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| ID | Type | Description | Link |
|---|---|---|---|
| 1UH3NS100553-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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The purpose of this study is to investigate the clinical efficacy of directional DBS electrode technology and whether electrophysiology biomarkers can predict effective contact segments for chronic therapy.
Although deep brain stimulation (DBS) can be remarkable for treating symptoms of Parkinson's disease, improvement varies across clinical trials, individual patients, and over time. A major limitation to the advancement of DBS therapy is that there are no established biomarkers to tailor stimulator settings in individuals. Emerging segmented ("directional") lead technology allows current steering, a new opportunity to improve tolerability and efficacy by shaping the DBS electrical field. This novel lead design has 8 contacts rather than the 4 available with currently available leads. How do the investigators optimally adjust stimulation parameters when there are far more potentially useful settings than can be practically evaluated in clinic? How do the investigators know that DBS settings in a given patient are optimal or appropriate? The investigators have pioneered minimally invasive, rapidly acquired biomarkers to solve these important problems. Using electrocorticography, electroencephalography, and subcortical local field potentials, the investigators will measure whether resting or stimulus-evoked electrophysiology can serve as a predictive biomarker to guide activation and adjustment of a directional DBS system. The purpose of this randomized, double-blind crossover study is to measure the clinical efficacy of directional versus omnidirectional stimulation and to explore whether electrophysiology biomarkers can rapidly predict effective, well-tolerated contacts for directional DBS therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Directional DBS guided by behavior | Active Comparator | Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation. |
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| Omnidirectional DBS guided by behavior | Placebo Comparator | Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation. |
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| Directional DBS guided by biomarkers | Active Comparator | Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Boston Scientific Vercise PC IPG with directional DBS lead | Device | Deep brain stimulation |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Preoperative Baseline in Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS Part III) "Off" Medications | A blinded examiner will measure Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 motor scores "off" medications. MDS-UPDRS Part III is a motor examination consisting of 18 summed items where the investigator rates the severity of Parkinson's motor symptoms based on a scale of 0 - 4. Higher values indicate worse function (possible min score = 0, possible max score = 72). A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | 2, 4, and 6 months post op |
| Treatment Preference Survey Programming Strategy Preference | Based on overall quality of life, participants will select their preference between directional and omnidirectional DBS. | 4 months post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Preoperative Baseline in the Beck Depression Inventory-2 (BDI-2) | The Beck Depression Inventory-2 is a 21 question self-report inventory which evaluates a person's severity of depression. Items are answered on a 0 - 3 scale. Higher values indicate worse function (possible min score = 0, possible max score = 63). A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harrison Walker, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35598419 | Derived | Black SD, Del Bene VA, Celka AS, Guthrie B, Martin RC, Olson J, Shumake J, Walker HC. Nascent visual artistic expression following right hemisphere subthalamic nucleus deep brain stimulation for Parkinson's disease. Parkinsonism Relat Disord. 2022 Jun;99:47-50. doi: 10.1016/j.parkreldis.2022.04.020. Epub 2022 May 1. No abstract available. |
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We will share data through the Data Archive BRAIN Initiative (DABI) data sharing consortium.
The data will be made available after analyses of the primary and secondary outcomes.
Users must set up an account on the DABI website to be able to access data.
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| ID | Title | Description |
|---|---|---|
| FG000 | Directional DBS by Behavior; Omnidirectional DBS by Behavior; Directional DBS by Biomarkers Last | Participants were randomly assigned to directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments. Next they were assigned to omnidirectional stimulation based on behavior. Finally, they were assigned to directional DBS based on biomarkers recorded in surgery. First Intervention (2 months), Second Intervention (2 months), and Third Intervention (2 months). |
| FG001 | Omnidirectional DBS by Behavior; Directional DBS by Behavior; Directional DBS by Biomarkers Last | Participants were randomly assigned to omnidirectional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments. Next they were assigned to directional stimulation based on behavior. Finally, they were assigned to directional DBS based on biomarkers recorded in surgery. First Intervention (2 months), Second Intervention (2 months), and Third Intervention (2 months). |
| FG002 | Either Directional DBS or Omnidirectional DBS by Behavior; Directional DBS by Biomarkers Last | Upon completion of the first two periods (either directional stimulation or omnidirectional stimulation based on behavioral assessments), all participants were assigned to a directional unilateral subthalamic stimulation strategy with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm). First Intervention (2 months), Second Intervention (2 months), and Third Intervention (2 months). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (2 Months) |
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| Second Intervention (2 Months) |
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| Third Intervention (2 Months) |
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All 31 participants experienced all arms of the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Aggregate baseline data for all study participants |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Preoperative Baseline in Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS Part III) "Off" Medications | A blinded examiner will measure Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 motor scores "off" medications. MDS-UPDRS Part III is a motor examination consisting of 18 summed items where the investigator rates the severity of Parkinson's motor symptoms based on a scale of 0 - 4. Higher values indicate worse function (possible min score = 0, possible max score = 72). A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | All participants experienced all three arms of the crossover study. | Posted | Mean | Standard Deviation | change from baseline units on a scale | 2, 4, and 6 months post op |
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1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Directional DBS Guided by Behavior | Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation. Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SAE1 | Cardiac disorders | Systematic Assessment | Myocardial infarction |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AE1 | Product Issues | Systematic Assessment | Short circuit between DBS contacts |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Program Manger | University of Alabama at Birmingham | (205) 934-0683 | clg17@uab.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 14, 2017 | Sep 21, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 30, 2023 | Nov 30, 2023 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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This is a triple blind, randomized crossover study of directional versus omnidirectional unilateral subthalamic deep brain stimulation for Parkinson's disease with motor fluctuations.
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This is a triple blind study. Participants, raters, and investigator are masked to the assignment of directional versus omnidirectional unilateral subthalamic deep brain stimulation guided by behavioral programming for Parkinson's disease with motor fluctuations. For the nested exploratory arm evaluating directional DBS guided by electrophysiology biomarkers, the study is double-blind (investigator is not blinded).
| 2, 4, and 6 months post op |
| Change From Preoperative Baseline in the Beck Anxiety Inventory (BAI) | The Beck Anxiety Inventory is a 21 question self-report inventory which evaluates a person's severity of anxiety. Items are answered on a 0 - 3 scale. Higher values indicate worse function (possible min score = 0, possible max score = 63). A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | 2, 4, and 6 months post op |
| Change From Preoperative Baseline in the Auditory Verbal Learning Test (AVLT) Delayed Recall Raw Score (Versions AB, CD, CR, GE) | The Auditory Verbal Learning Test (AVLT) delayed recall raw score (versions AB, CD, CR, GE) evaluates a person's ability to encode, consolidate, store, and retrieve verbal information. Participants are read a list of 12 words and later asked to recall the items on the list. Scores indicate the number of items recalled. Higher values indicate better function (possible min score = 0, possible max score = 12). A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | 2, 4, and 6 months post op |
| Change From Preoperative Baseline in the Auditory Verbal Learning Test (AVLT) Recognition Raw Score (Versions AB, CD, CR, GE) | The Auditory Verbal Learning Test (AVLT) Recognition Raw Score (versions AB, CD, CR, GE) evaluates a person's ability to encode, consolidate, store, and retrieve verbal information. Participants are given a list of 15 target words. The list is taken away and each is asked to now pick out the 15 target words from a larger list of 30 words. Scores indicate the overall number of target words correctly recognized (minimum = 0, maximum = 15). Higher scores indicate better performance. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | 2, 4, and 6 months post op |
| Change From Preoperative Baseline in the Auditory Verbal Learning Test (AVLT) Learning Raw Score (Versions AB, CD, CR, GE) | The AVLT (versions AB, CD, CR, GE) evaluates a person's ability to encode, consolidate, store, and retrieve verbal information. Participants are read a list of 12 words and asked to immediately recall the items on the list over 6 separate trials. Scores indicate the number of items recalled. Higher values indicate better function (possible min score = 0, possible max score = 72). A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | 2, 4, and 6 months post op |
| Change From Preoperative Baseline in the Letter Fluency Test Raw Score (Version: CFL, FAS) | The Letter Fluency Test (version: CFL, FAS) evaluates the number of words beginning with the letters C, F, L, A, and S that a participant can produce in one minute (minimum = 0, maximum = infinity). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | 2, 4, and 6 months post op |
| Change From Preoperative Baseline in the Voice Handicap Index | The Voice Handicap Index evaluates speech function with a 30-item self-administered questionnaire that asks participants to describe their voice and the effects of their voice on their lives. Participants respond on a 0 - 4 scale (minimum = 0, maximum = 120. Higher scores indicate worse functiion. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | 2, 4, and 6 months post op |
| Change From Preoperative Baseline in the Communicative Participation Item Bank (CPIB) | The Communicative Participation Item Bank (CPIB) evaluates the extent to which communication disorders interfere with communicative participation. Participants respond on a 0 - 3 scale (minimum = 0, maximum = 30). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | 2, 4, and 6 months post op |
| Change From Preoperative Baseline in the 9-Hole Pegboard Test | The 9-Hole Pegboard Test evaluates one's upper extremity motor function. It is a timed test in which participants place 9 pegs in a pegboard and then remove them. Faster times indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | 2, 4, and 6 months post op |
| Change From Preoperative Baseline in Gait Initiation Test | The gait initiation test evaluates the phase between standing motionless and steady-state locomotion. This is a timed test in which participants are given a go signal and the time until first stride is recorded. Faster times indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | 2, 4, and 6 months post op |
| Change From Preoperative Baseline in Stepping Thresholds Test | The stepping thresholds test evaluates a person's compensatory stepping thresholds. This is a test in which the floor surface is unexpectedly moved beneath a participant. The distance a participant moves their feet in order to compensate is recorded. The smaller displacement scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | 2, 4, and 6 months post op |
| Change From Preoperative Baseline in Quiet Stance Measure | The quiet stance measure evaluates a person's postural control during quiet standing. This is a measure of sway distance. Lower scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | 2, 4, and 6 months post op |
| Change From Preoperative Baseline in the Parkinson's Disease Quality of Life | The Parkinson's Disease Quality of Life (PDQ-8) evaluates overall health status. It consists of eight questions regarding mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. Participants choose answers on a scale ranging from never (0) to always (4) (minimum = 0, maximum = 32). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | 2, 4, and 6 months post op |
| Change From Preoperative Baseline in the the Neuro-QOL Item Bank v1.0 "Positive Affect and Well-Being" Short Form | The Neuro-QOL Item Bank v1.0 "Positive Affect and Well-Being" Short Form evaluates feelings that reflect a level of general satisfaction with life as well as a sense that life has purpose and meaning. Participants respond to questions on a 1-5 scale (minimum = 9, maximum = 45). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | 2, 4, and 6 months post op |
| Change From Preoperative Baseline in the Neuro-QOL Item Bank v1.1 "Satisfaction With Social Roles and Activities" Short Form | The Neuro-QOL Item Bank v1.1 "Satisfaction with Social Roles and Activities" short form short form evaluates one's satisfaction and discontentment with performing usual social roles and activities. Participants respond to questions on a 1-5 scale (minimum = 8, maximum = 40). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | 2, 4, and 6 months post op |
| Change From Preoperative Baseline in the Neuro-QOL Item Bank v2.0 "Cognitive Function" Short Form | The Neuro-QOL Item Bank v2.0 ""Cognitive Function" short form evaluates mental acuity, concentration, verbal and nonverbal memory, verbal fluency, and perceived changes in these cognitive functions. Participants respond to questions on a 1-5 scale (minimum = 8, maximum = 40). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | 2, 4, and 6 months post op |
| Change From Preoperative Baseline in the Neuro-QOL Item Bank v1.0 "Lower Extremity Function (Mobility)" Short Form | The Neuro-QOL Item Bank v1.0 "Lower Extremity Function (Mobility)" short form evaluates functioning of one's lower extremities. Participants respond to questions on a 1-5 scale (minimum = 8, maximum = 40). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | 2, 4, and 6 months post op |
| Change From Preoperative Baseline in the Neuro-QOL Item Bank v1.0 "Upper Extremity Function (Fine Motor, ADL)" Short Form | The Neuro-QOL Item Bank v1.0 "Upper Extremity Function (Fine Motor, ADL)" short form evaluates functioning of one's upper extremity function in fine motor and ADL capabilities. Participants respond to questions on a 1-5 scale (minimum = 9, maximum = 45). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | 2, 4, and 6 months post op |
| Change From Preoperative Baseline in the Neuro-QOL Item Bank v1.0 "Stigma" Short Form | The Neuro-QOL Item Bank v1.0 "Stigma" short form evaluates one's sensitivity of illness-related stigma. Participants respond to questions on a 1-5 scale (minimum = 8, maximum = 40). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | 2, 4, and 6 months post op |
| Change From Preoperative Baseline in the Neuro-QOL Scale v1.0 "Communication" Short Form | The Neuro-QOL Scale v1.0 "Communication" short form evaluates one's difficulty with communication. Participants respond to questions on a 1-5 scale (minimum = 5, maximum = 25). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | 2, 4, and 6 months post op |
| Change From Preoperative Baseline in the Neuro-QOL Item Bank v1.0 "Emotional and Behavioral Dyscontrol" Short Form | Neuro-QOL Item Bank v1.0 "Emotional and Behavioral Dyscontrol" short form evaluates one's confidence to manage/control symptoms of frustration, disappointment, anger, and other negative emotions. Participants respond to questions on a 1-5 scale (minimum = 8, maximum = 40). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | 2, 4, and 6 months post op |
| Change From Preoperative Baseline in Patient-Reported Outcomes Measurement Information System PROMIS v1.0 "Global Health" Short Form | The PROMIS v1.0 "Global Health" short form evaluates the individual's global health. This is a 10 question scale on which 9 of the questions are answered with a 1 - 5 score. The remaining item is answered with a 0 - 10 score. (minimum = 9, maximum = 55). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | 2, 4, and 6 months post op |
| Change From Preoperative Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 "Global Health Mental Health Score" | The (PROMIS) Scale v1.2 "Global Health" evaluates one's overall physical and mental health. This is a 10 item scale with scores ranging from 4-20. Higher scores indicate better overall health. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | 2, 4, and 6 months post op |
| Change From Preoperative Baseline in Patient-Reported Outcomes Measurement Information System PROMIS v2.0 "Ability to Participate in Social Roles and Activities" Short Form | The PROMIS v2.0 "Ability to Participate in Social Roles and Activities" short form evaluates one's perceived ability to perform one's usual social roles and activities. This is an 8 question measure and answers are given on a 1 - 5 scale (minimum = 8, maximum = 40). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | 2, 4, and 6 months post op |
| Change From Preoperative Baseline in Patient-Reported Outcomes Measurement Information System PROMIS v1.0 "Emotional Distress - Anxiety" Short Form | The PROMIS v1.0 "Emotional Distress - Anxiety" short form evaluates one's feelings of anxiety, such as fear and worry. This is a 7 item scale and participants answer with a 1 - 5 score for each item (minimum = 7, maximum = 35). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | 2, 4, and 6 months post op |
| Change From Preoperative Baseline in Patient-Reported Outcomes Measurement Information System PROMIS v1.0 "Emotional Distress - Depression" Short Form | The PROMIS v1.0 "Emotional Distress - Depression" short form evaluates one's feelings of negative mood and depression. This is an 8 item scale and participants answer with a 1 - 5 score for each item (minimum = 8, maximum = 40). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | 2, 4, and 6 months post op |
| Change From Preoperative Baseline in Patient-Reported Outcomes Measurement Information System PROMIS v1.0 "Fatigue" Short Form | The PROMIS v1.0 "Fatigue" short form evaluates one's range of symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. This is a 6 item scale and participants answer with a 1 - 5 score for each item (minimum = 6, maximum = 30). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | 2, 4, and 6 months post op |
| Change From Preoperative Baseline in Patient-Reported Outcomes Measurement Information System PROMIS v2.0 "Physical Function" Short Form | The PROMIS v2.0 "Physical Function" short form measures self-reported capability rather than actual performance of physical activities. This is a 10 item scale and participants answer with a 1 - 5 score for each item (minimum = 10, maximum = 50). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | 2, 4, and 6 months post op |
| Change From Preoperative Baseline in Patient-Reported Outcomes Measurement | The PROMIS v1.0 "Pain Interference" short form evaluates the consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. This is a 6 item scale and participants answer with a 1 - 5 score for each item (minimum = 6, maximum = 30). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | 2, 4, and 6 months post op |
| Change From Preoperative Baseline in Patient-Reported Outcomes Measurement Information System PROMIS v1.0 "Sleep Disturbance" Short Form | The PROMIS v1.0 "Sleep Disturbance" short form evaluates one's perceptions of sleep quality. This is an 8 item scale and participants answer with a 1 - 5 score for each item (minimum = 8, maximum = 40). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | 2, 4, and 6 months post op |
| Change From Preoperative Baseline in NIH Toolbox Cognition Battery Dimensional Change Card Sort Score | The NIH Toolbox Cognition Battery evaluates cognitive function with Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, List Sorting Working Memory Test, Picture Vocabulary Test, Pattern Comparison Processing Speed Test, Picture Sequence Memory Test, and Oral Reading Recognition. On this test participants are asked to match pictures to a category and receive one point for each correct match (minimum = 0, maximum = 40). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | 2, 4, and 6 months post op |
| Change From Preoperative Baseline in NIH Toolbox Cognition Battery Flanker Test Score | The NIH Toolbox Cognition Battery evaluates cognitive function with Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, List Sorting Working Memory Test, Picture Vocabulary Test, Pattern Comparison Processing Speed Test, Picture Sequence Memory Test, and Oral Reading Recognition. The Flanker Test is a test in which participants are asked to focus on a particular stimulus while inhibiting attention to another. An accuracy score is derived by calculating (Accuracy Score = 0.125 * Number of Correct Responses) (minimum=0, maximum=5). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | 2, 4, and 6 months post op |
| Change From Preoperative Baseline in NIH Toolbox Cognition Battery List Sorting Working Memory Test Score | The NIH Toolbox Cognition Battery evaluates cognitive function with Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, List Sorting Working Memory Test, Picture Vocabulary Test, Pattern Comparison Processing Speed Test, Picture Sequence Memory Test, and Oral Reading Recognition. The list sorting working memory test is a test in which lists of items are presented and participants are asked to recall items from the list in a particular order. Scoring is done based on the number of items correctly recalled and sequenced (minimum = 0, maximum = 26). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | 2, 4, and 6 months post op |
| Change From Preoperative Baseline in NIH Toolbox Cognition Battery Oral Reading Test Score | The NIH Toolbox Cognition Battery evaluates cognitive function with Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, List Sorting Working Memory Test, Picture Vocabulary Test, Pattern Comparison Processing Speed Test, Picture Sequence Memory Test, and Oral Reading Recognition. The oral reading recognition test is a test in which participants are asked to read and pronounce words as accurately as possible. Pronunciation is judged by the test administrator and a score is given to each response (minimum = 0, maximum = 25). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | 2, 4, and 6 months post op |
| Change From Preoperative Baseline in NIH Toolbox Cognition Battery Pattern Comparison Test Score | The NIH Toolbox Cognition Battery evaluates cognitive function with Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, List Sorting Working Memory Test, Picture Vocabulary Test, Pattern Comparison Processing Speed Test, Picture Sequence Memory Test, and Oral Reading Recognition. The pattern comparison test is a test in which participants are presented with two pictures and are asked to discern whether they are he same or different. Correct answers are given one point for up to a maximum of 130 trials (minimum = 0, maximum = 130). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | 2, 4, and 6 months post op |
| Change From Preoperative Baseline in NIH Toolbox Cognition Battery Picture Sequencing Test Score | The picture sequencing test is a test of episodic memory in which participants are asked to recall increasingly lengthy series of illustrated objects and activities that are presented in a particular order on a computer screen. Participants are given credit for each adjacent pair of pictures they correctly place up to the maximum value for the sequence, which is one less than the sequence length (minimum = 0, maximum = 105). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | 2, 4, and 6 months post op |
| Change From Preoperative Baseline in NIH Toolbox Cognition Battery Picture Vocabulary Test Score | The NIH Toolbox Cognition Battery evaluates cognitive function with Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, List Sorting Working Memory Test, Picture Vocabulary Test, Pattern Comparison Processing Speed Test, Picture Sequence Memory Test, and Oral Reading Recognition. The picture vocabulary test is a test in which participants are presented with an audio recording of a word and four photographic images on the computer screen and asked to select the picture that most closely matches the meaning of the word (minimum = 0, maximum = 25). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | 2, 4, and 6 months post op |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG000 |
| Directional DBS Guided by Behavior |
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation. Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation |
| OG001 | Omnidirectional DBS Guided by Behavior | Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation. Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation |
| OG002 | Directional DBS Guided by Biomarkers | Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm). Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation |
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| Primary | Treatment Preference Survey Programming Strategy Preference | Based on overall quality of life, participants will select their preference between directional and omnidirectional DBS. | All participants experienced all three arms of the crossover study. | Posted | Count of Participants | Participants | 4 months post surgery |
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| Secondary | Change From Preoperative Baseline in the Beck Depression Inventory-2 (BDI-2) | The Beck Depression Inventory-2 is a 21 question self-report inventory which evaluates a person's severity of depression. Items are answered on a 0 - 3 scale. Higher values indicate worse function (possible min score = 0, possible max score = 63). A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | All participants experienced all three arms of the crossover study. | Posted | Mean | Standard Deviation | change from baseline units on a scale | 2, 4, and 6 months post op |
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| Secondary | Change From Preoperative Baseline in the Beck Anxiety Inventory (BAI) | The Beck Anxiety Inventory is a 21 question self-report inventory which evaluates a person's severity of anxiety. Items are answered on a 0 - 3 scale. Higher values indicate worse function (possible min score = 0, possible max score = 63). A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | All participants experienced all three arms of the crossover study. | Posted | Mean | Standard Deviation | change from baseline units on a scale | 2, 4, and 6 months post op |
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| Secondary | Change From Preoperative Baseline in the Auditory Verbal Learning Test (AVLT) Delayed Recall Raw Score (Versions AB, CD, CR, GE) | The Auditory Verbal Learning Test (AVLT) delayed recall raw score (versions AB, CD, CR, GE) evaluates a person's ability to encode, consolidate, store, and retrieve verbal information. Participants are read a list of 12 words and later asked to recall the items on the list. Scores indicate the number of items recalled. Higher values indicate better function (possible min score = 0, possible max score = 12). A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | All participants experienced all three arms of the crossover study. | Posted | Mean | Standard Deviation | change from baseline units on a scale | 2, 4, and 6 months post op |
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| Secondary | Change From Preoperative Baseline in the Auditory Verbal Learning Test (AVLT) Recognition Raw Score (Versions AB, CD, CR, GE) | The Auditory Verbal Learning Test (AVLT) Recognition Raw Score (versions AB, CD, CR, GE) evaluates a person's ability to encode, consolidate, store, and retrieve verbal information. Participants are given a list of 15 target words. The list is taken away and each is asked to now pick out the 15 target words from a larger list of 30 words. Scores indicate the overall number of target words correctly recognized (minimum = 0, maximum = 15). Higher scores indicate better performance. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | All participants experienced all three arms of the crossover study. | Posted | Mean | Standard Deviation | change from baseline units on a scale | 2, 4, and 6 months post op |
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| Secondary | Change From Preoperative Baseline in the Auditory Verbal Learning Test (AVLT) Learning Raw Score (Versions AB, CD, CR, GE) | The AVLT (versions AB, CD, CR, GE) evaluates a person's ability to encode, consolidate, store, and retrieve verbal information. Participants are read a list of 12 words and asked to immediately recall the items on the list over 6 separate trials. Scores indicate the number of items recalled. Higher values indicate better function (possible min score = 0, possible max score = 72). A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | All participants experienced all three arms of the crossover study. | Posted | Mean | Standard Deviation | change from baseline units on a scale | 2, 4, and 6 months post op |
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| Secondary | Change From Preoperative Baseline in the Letter Fluency Test Raw Score (Version: CFL, FAS) | The Letter Fluency Test (version: CFL, FAS) evaluates the number of words beginning with the letters C, F, L, A, and S that a participant can produce in one minute (minimum = 0, maximum = infinity). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | All participants experienced all three arms of the crossover study. | Posted | Mean | Standard Deviation | words generated | 2, 4, and 6 months post op |
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| Secondary | Change From Preoperative Baseline in the Voice Handicap Index | The Voice Handicap Index evaluates speech function with a 30-item self-administered questionnaire that asks participants to describe their voice and the effects of their voice on their lives. Participants respond on a 0 - 4 scale (minimum = 0, maximum = 120. Higher scores indicate worse functiion. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | All participants experienced all three arms of the crossover study. | Posted | Mean | Standard Deviation | change from baseline units on a scale | 2, 4, and 6 months post op |
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| Secondary | Change From Preoperative Baseline in the Communicative Participation Item Bank (CPIB) | The Communicative Participation Item Bank (CPIB) evaluates the extent to which communication disorders interfere with communicative participation. Participants respond on a 0 - 3 scale (minimum = 0, maximum = 30). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | All participants experienced all three arms of the crossover study. | Posted | Mean | Standard Deviation | change from baseline units on a scale | 2, 4, and 6 months post op |
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| Secondary | Change From Preoperative Baseline in the 9-Hole Pegboard Test | The 9-Hole Pegboard Test evaluates one's upper extremity motor function. It is a timed test in which participants place 9 pegs in a pegboard and then remove them. Faster times indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | All participants experienced all three arms of the crossover study. | Posted | Mean | Standard Deviation | time (seconds) | 2, 4, and 6 months post op |
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| Secondary | Change From Preoperative Baseline in Gait Initiation Test | The gait initiation test evaluates the phase between standing motionless and steady-state locomotion. This is a timed test in which participants are given a go signal and the time until first stride is recorded. Faster times indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | All participants experienced all three arms of the crossover study. | Posted | Mean | Standard Deviation | time (seconds) | 2, 4, and 6 months post op |
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| Secondary | Change From Preoperative Baseline in Stepping Thresholds Test | The stepping thresholds test evaluates a person's compensatory stepping thresholds. This is a test in which the floor surface is unexpectedly moved beneath a participant. The distance a participant moves their feet in order to compensate is recorded. The smaller displacement scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | All participants experienced all three arms of the crossover study. | Posted | Mean | Standard Deviation | mm displacement | 2, 4, and 6 months post op |
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| Secondary | Change From Preoperative Baseline in Quiet Stance Measure | The quiet stance measure evaluates a person's postural control during quiet standing. This is a measure of sway distance. Lower scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | All participants experienced all three arms of the crossover study. | Posted | Mean | Standard Deviation | change from baseline mm sway | 2, 4, and 6 months post op |
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| Secondary | Change From Preoperative Baseline in the Parkinson's Disease Quality of Life | The Parkinson's Disease Quality of Life (PDQ-8) evaluates overall health status. It consists of eight questions regarding mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. Participants choose answers on a scale ranging from never (0) to always (4) (minimum = 0, maximum = 32). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | All participants experienced all three arms of the crossover study. | Posted | Mean | Standard Deviation | change from baseline units on a scale | 2, 4, and 6 months post op |
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| Secondary | Change From Preoperative Baseline in the the Neuro-QOL Item Bank v1.0 "Positive Affect and Well-Being" Short Form | The Neuro-QOL Item Bank v1.0 "Positive Affect and Well-Being" Short Form evaluates feelings that reflect a level of general satisfaction with life as well as a sense that life has purpose and meaning. Participants respond to questions on a 1-5 scale (minimum = 9, maximum = 45). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | All participants experienced all three arms of the crossover study. | Posted | Mean | Standard Deviation | change from baseline units on a scale | 2, 4, and 6 months post op |
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| Secondary | Change From Preoperative Baseline in the Neuro-QOL Item Bank v1.1 "Satisfaction With Social Roles and Activities" Short Form | The Neuro-QOL Item Bank v1.1 "Satisfaction with Social Roles and Activities" short form short form evaluates one's satisfaction and discontentment with performing usual social roles and activities. Participants respond to questions on a 1-5 scale (minimum = 8, maximum = 40). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | All participants experienced all three arms of the crossover study. | Posted | Mean | Standard Deviation | change from baseline units on a scale | 2, 4, and 6 months post op |
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| Secondary | Change From Preoperative Baseline in the Neuro-QOL Item Bank v2.0 "Cognitive Function" Short Form | The Neuro-QOL Item Bank v2.0 ""Cognitive Function" short form evaluates mental acuity, concentration, verbal and nonverbal memory, verbal fluency, and perceived changes in these cognitive functions. Participants respond to questions on a 1-5 scale (minimum = 8, maximum = 40). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | All participants experienced all three arms of the crossover study. | Posted | Mean | Standard Deviation | change from baseline units on a scale | 2, 4, and 6 months post op |
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| Secondary | Change From Preoperative Baseline in the Neuro-QOL Item Bank v1.0 "Lower Extremity Function (Mobility)" Short Form | The Neuro-QOL Item Bank v1.0 "Lower Extremity Function (Mobility)" short form evaluates functioning of one's lower extremities. Participants respond to questions on a 1-5 scale (minimum = 8, maximum = 40). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | All participants experienced all three arms of the crossover study. | Posted | Mean | Standard Deviation | change from baseline units on a scale | 2, 4, and 6 months post op |
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| Secondary | Change From Preoperative Baseline in the Neuro-QOL Item Bank v1.0 "Upper Extremity Function (Fine Motor, ADL)" Short Form | The Neuro-QOL Item Bank v1.0 "Upper Extremity Function (Fine Motor, ADL)" short form evaluates functioning of one's upper extremity function in fine motor and ADL capabilities. Participants respond to questions on a 1-5 scale (minimum = 9, maximum = 45). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | All participants experienced all three arms of the crossover study. | Posted | Mean | Standard Deviation | change from baseline units on a scale | 2, 4, and 6 months post op |
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| Secondary | Change From Preoperative Baseline in the Neuro-QOL Item Bank v1.0 "Stigma" Short Form | The Neuro-QOL Item Bank v1.0 "Stigma" short form evaluates one's sensitivity of illness-related stigma. Participants respond to questions on a 1-5 scale (minimum = 8, maximum = 40). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | All participants experienced all three arms of the crossover study. | Posted | Mean | Standard Deviation | change from baseline units on a scale | 2, 4, and 6 months post op |
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| Secondary | Change From Preoperative Baseline in the Neuro-QOL Scale v1.0 "Communication" Short Form | The Neuro-QOL Scale v1.0 "Communication" short form evaluates one's difficulty with communication. Participants respond to questions on a 1-5 scale (minimum = 5, maximum = 25). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | All participants experienced all three arms of the crossover study. | Posted | Mean | Standard Deviation | change from baseline units on a scale | 2, 4, and 6 months post op |
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| Secondary | Change From Preoperative Baseline in the Neuro-QOL Item Bank v1.0 "Emotional and Behavioral Dyscontrol" Short Form | Neuro-QOL Item Bank v1.0 "Emotional and Behavioral Dyscontrol" short form evaluates one's confidence to manage/control symptoms of frustration, disappointment, anger, and other negative emotions. Participants respond to questions on a 1-5 scale (minimum = 8, maximum = 40). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | All participants experienced all three arms of the crossover study. | Posted | Mean | Standard Deviation | change from baseline units on a scale | 2, 4, and 6 months post op |
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| Secondary | Change From Preoperative Baseline in Patient-Reported Outcomes Measurement Information System PROMIS v1.0 "Global Health" Short Form | The PROMIS v1.0 "Global Health" short form evaluates the individual's global health. This is a 10 question scale on which 9 of the questions are answered with a 1 - 5 score. The remaining item is answered with a 0 - 10 score. (minimum = 9, maximum = 55). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | All participants experienced all three arms of the crossover study. | Posted | Mean | Standard Deviation | change from baseline units on a scale | 2, 4, and 6 months post op |
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| Secondary | Change From Preoperative Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 "Global Health Mental Health Score" | The (PROMIS) Scale v1.2 "Global Health" evaluates one's overall physical and mental health. This is a 10 item scale with scores ranging from 4-20. Higher scores indicate better overall health. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | All participants experienced all three arms of the crossover study. | Posted | Mean | Standard Deviation | change from baseline units on a scale | 2, 4, and 6 months post op |
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| Secondary | Change From Preoperative Baseline in Patient-Reported Outcomes Measurement Information System PROMIS v2.0 "Ability to Participate in Social Roles and Activities" Short Form | The PROMIS v2.0 "Ability to Participate in Social Roles and Activities" short form evaluates one's perceived ability to perform one's usual social roles and activities. This is an 8 question measure and answers are given on a 1 - 5 scale (minimum = 8, maximum = 40). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | All participants experienced all three arms of the crossover study. | Posted | Mean | Standard Deviation | change from baseline units on a scale | 2, 4, and 6 months post op |
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| Secondary | Change From Preoperative Baseline in Patient-Reported Outcomes Measurement Information System PROMIS v1.0 "Emotional Distress - Anxiety" Short Form | The PROMIS v1.0 "Emotional Distress - Anxiety" short form evaluates one's feelings of anxiety, such as fear and worry. This is a 7 item scale and participants answer with a 1 - 5 score for each item (minimum = 7, maximum = 35). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | All participants experienced all three arms of the crossover study. | Posted | Mean | Standard Deviation | change from baseline units on a scale | 2, 4, and 6 months post op |
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| Secondary | Change From Preoperative Baseline in Patient-Reported Outcomes Measurement Information System PROMIS v1.0 "Emotional Distress - Depression" Short Form | The PROMIS v1.0 "Emotional Distress - Depression" short form evaluates one's feelings of negative mood and depression. This is an 8 item scale and participants answer with a 1 - 5 score for each item (minimum = 8, maximum = 40). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | All participants experienced all three arms of the crossover study. | Posted | Mean | Standard Deviation | change from baseline units on a scale | 2, 4, and 6 months post op |
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| Secondary | Change From Preoperative Baseline in Patient-Reported Outcomes Measurement Information System PROMIS v1.0 "Fatigue" Short Form | The PROMIS v1.0 "Fatigue" short form evaluates one's range of symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. This is a 6 item scale and participants answer with a 1 - 5 score for each item (minimum = 6, maximum = 30). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | All participants experienced all three arms of the crossover study. | Posted | Mean | Standard Deviation | change from baseline units on a scale | 2, 4, and 6 months post op |
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| Secondary | Change From Preoperative Baseline in Patient-Reported Outcomes Measurement Information System PROMIS v2.0 "Physical Function" Short Form | The PROMIS v2.0 "Physical Function" short form measures self-reported capability rather than actual performance of physical activities. This is a 10 item scale and participants answer with a 1 - 5 score for each item (minimum = 10, maximum = 50). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | All participants experienced all three arms of the crossover study. | Posted | Mean | Standard Deviation | change from baseline units on a scale | 2, 4, and 6 months post op |
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| Secondary | Change From Preoperative Baseline in Patient-Reported Outcomes Measurement | The PROMIS v1.0 "Pain Interference" short form evaluates the consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. This is a 6 item scale and participants answer with a 1 - 5 score for each item (minimum = 6, maximum = 30). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | All participants experienced all three arms of the crossover study. | Posted | Mean | Standard Deviation | change from baseline units on a scale | 2, 4, and 6 months post op |
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| Secondary | Change From Preoperative Baseline in Patient-Reported Outcomes Measurement Information System PROMIS v1.0 "Sleep Disturbance" Short Form | The PROMIS v1.0 "Sleep Disturbance" short form evaluates one's perceptions of sleep quality. This is an 8 item scale and participants answer with a 1 - 5 score for each item (minimum = 8, maximum = 40). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | All participants experienced all three arms of the crossover study. | Posted | Mean | Standard Deviation | change from baseline units on a scale | 2, 4, and 6 months post op |
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| Secondary | Change From Preoperative Baseline in NIH Toolbox Cognition Battery Dimensional Change Card Sort Score | The NIH Toolbox Cognition Battery evaluates cognitive function with Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, List Sorting Working Memory Test, Picture Vocabulary Test, Pattern Comparison Processing Speed Test, Picture Sequence Memory Test, and Oral Reading Recognition. On this test participants are asked to match pictures to a category and receive one point for each correct match (minimum = 0, maximum = 40). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | All participants experienced all three arms of the crossover study. | Posted | Mean | Standard Deviation | change from baseline units on a scale | 2, 4, and 6 months post op |
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| Secondary | Change From Preoperative Baseline in NIH Toolbox Cognition Battery Flanker Test Score | The NIH Toolbox Cognition Battery evaluates cognitive function with Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, List Sorting Working Memory Test, Picture Vocabulary Test, Pattern Comparison Processing Speed Test, Picture Sequence Memory Test, and Oral Reading Recognition. The Flanker Test is a test in which participants are asked to focus on a particular stimulus while inhibiting attention to another. An accuracy score is derived by calculating (Accuracy Score = 0.125 * Number of Correct Responses) (minimum=0, maximum=5). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | All participants experienced all three arms of the crossover study. | Posted | Mean | Standard Deviation | accuracy score | 2, 4, and 6 months post op |
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| Secondary | Change From Preoperative Baseline in NIH Toolbox Cognition Battery List Sorting Working Memory Test Score | The NIH Toolbox Cognition Battery evaluates cognitive function with Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, List Sorting Working Memory Test, Picture Vocabulary Test, Pattern Comparison Processing Speed Test, Picture Sequence Memory Test, and Oral Reading Recognition. The list sorting working memory test is a test in which lists of items are presented and participants are asked to recall items from the list in a particular order. Scoring is done based on the number of items correctly recalled and sequenced (minimum = 0, maximum = 26). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | All participants experienced all three arms of the crossover study. | Posted | Mean | Standard Deviation | change from baseline units on a scale | 2, 4, and 6 months post op |
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| Secondary | Change From Preoperative Baseline in NIH Toolbox Cognition Battery Oral Reading Test Score | The NIH Toolbox Cognition Battery evaluates cognitive function with Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, List Sorting Working Memory Test, Picture Vocabulary Test, Pattern Comparison Processing Speed Test, Picture Sequence Memory Test, and Oral Reading Recognition. The oral reading recognition test is a test in which participants are asked to read and pronounce words as accurately as possible. Pronunciation is judged by the test administrator and a score is given to each response (minimum = 0, maximum = 25). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | All participants experienced all three arms of the crossover study. | Posted | Mean | Standard Deviation | words/letters correctly pronounced | 2, 4, and 6 months post op |
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| Secondary | Change From Preoperative Baseline in NIH Toolbox Cognition Battery Pattern Comparison Test Score | The NIH Toolbox Cognition Battery evaluates cognitive function with Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, List Sorting Working Memory Test, Picture Vocabulary Test, Pattern Comparison Processing Speed Test, Picture Sequence Memory Test, and Oral Reading Recognition. The pattern comparison test is a test in which participants are presented with two pictures and are asked to discern whether they are he same or different. Correct answers are given one point for up to a maximum of 130 trials (minimum = 0, maximum = 130). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | All participants experienced all three arms of the crossover study. | Posted | Mean | Standard Deviation | units on a scale | 2, 4, and 6 months post op |
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| Secondary | Change From Preoperative Baseline in NIH Toolbox Cognition Battery Picture Sequencing Test Score | The picture sequencing test is a test of episodic memory in which participants are asked to recall increasingly lengthy series of illustrated objects and activities that are presented in a particular order on a computer screen. Participants are given credit for each adjacent pair of pictures they correctly place up to the maximum value for the sequence, which is one less than the sequence length (minimum = 0, maximum = 105). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | All participants experienced all three arms of the crossover study. | Posted | Mean | Standard Deviation | number of correct sequences identified | 2, 4, and 6 months post op |
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| Secondary | Change From Preoperative Baseline in NIH Toolbox Cognition Battery Picture Vocabulary Test Score | The NIH Toolbox Cognition Battery evaluates cognitive function with Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, List Sorting Working Memory Test, Picture Vocabulary Test, Pattern Comparison Processing Speed Test, Picture Sequence Memory Test, and Oral Reading Recognition. The picture vocabulary test is a test in which participants are presented with an audio recording of a word and four photographic images on the computer screen and asked to select the picture that most closely matches the meaning of the word (minimum = 0, maximum = 25). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers. | All participants experienced all three arms of the crossover study. | Posted | Mean | Standard Deviation | number of correct matches | 2, 4, and 6 months post op |
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| 0 |
| 30 |
| 3 |
| 31 |
| 2 |
| 31 |
| EG001 | Omnidirectional DBS Guided by Behavior | Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation. Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation | 0 | 30 | 4 | 31 | 0 | 31 |
| EG002 | Directional DBS Guided by Biomarkers | Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm). Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation | 0 | 30 | 0 | 31 | 0 | 31 |
| SAE2 | Surgical and medical procedures | Systematic Assessment | DBS lead placed suboptimally |
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| SAE3 | Nervous system disorders | Systematic Assessment | Postoperative seizure |
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| SAE4 | Psychiatric disorders | Systematic Assessment | Panic attack |
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| SAE5 | Product Issues | Systematic Assessment | Separation of product components post surgery |
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Not provided
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |