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This single-center, randomized, quadruple-blinded, double-crossover comparative efficacy trial will study the effects of unilateral 50% voltage reduction in axial motor dysfunction for patients with Parkinson's disease that develop treatment-resistant postural stability gait dysfunction after bilateral subthalamic nucleus deep brain stimulation surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baseline STN-DBS | No Intervention | Maintenance of baseline bilateral STN-DBS settings. | |
| Asymmetric STN-DBS 1 | Experimental | Unilateral 50% reduction of voltage (e.g. right side) |
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| Asymmetric STN-DBS 2 | Experimental | Unilateral 50% reduction of voltage (e.g. left side) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Asymmetric STN-DBS | Other | Asymmetric deep brain stimulation |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Gait Velocity | As measured during the 10-meter walk test. In this test, participants walk at their usual, regular pace over a total distance of 10 meters. The middle 6-meters (between the 2-meter and 8-meter marks) are timed to measure gait velocity during steady-state gait. | Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Motor Function | As measured by the MDS-UPDRS (Movement Disorders Society Unified Parkinson's Disease Rating Scale), which is a clinical and research tool to measure symptoms and signs of Parkinson's disease. It has 4 parts: I (non-motor experiences of daily living), II (motor experiences of daily living), III (motor exam) and IV (motor complications). The MDS-UPDRS has 60 items, scored from 0-4 each. The minimum score is 0 and the maximum score is 240. The MDS-UPDRS (motor) is Part III and measures motor signs. It has 28 items, scored from 0-4 each, so the minimum score is 0 and the maximum score is 112. The MDS-UPDRS (axial motor) is composed of items 3.1 to 3.3a and 3.9 to 3.13 of Part III of the MDS-UPDRS and measures axial motor signs. It has 8 items, scored from 0-4 each, so the minimum score is 0 and the maximum score is 32. In the MDS-UPDRS total, motor and axial motor sub-scales, lower scores indicate better symptoms/signs and higher scores indicate worse symptoms/signs, respectively. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alfonso Fasano, MD, PhD | University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Movement disorders Centre, Toronto Western Hospital | Toronto | Ontario | M5T 2S8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21370271 | Background | Fasano A, Herzog J, Seifert E, Stolze H, Falk D, Reese R, Volkmann J, Deuschl G. Modulation of gait coordination by subthalamic stimulation improves freezing of gait. Mov Disord. 2011 Apr;26(5):844-51. doi: 10.1002/mds.23583. Epub 2011 Mar 2. | |
| 27278062 | Background | Lizarraga KJ, Jagid JR, Luca CC. Comparative effects of unilateral and bilateral subthalamic nucleus deep brain stimulation on gait kinematics in Parkinson's disease: a randomized, blinded study. J Neurol. 2016 Aug;263(8):1652-6. doi: 10.1007/s00415-016-8191-3. Epub 2016 Jun 8. |
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To be shared as supplementary data upon publication of the results of the trial.
To be shared as supplementary data upon publication of the results of the trial.
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22 of 38 patients were enrolled. Of the 16 patients not enrolled, 9 did not meet inclusion criteria and 7 declined to participate.
There were no significant events between enrollment and randomization.
The first study participant was enrolled on March 14, 2018. The last study participant was enrolled on January 29, 2019.
38 patients with Parkinson's disease (PD) who developed postural instability gait dysfunction (PIGD) after bilateral subthalamic (STN) deep brain stimulation (DBS) were screened for eligibility between January 22, 2018 and January 29, 2019 at the DBS clinic of the Movement Disorders Center at the University of Toronto in Toronto, Ontario, Canada.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bilateral DBS Then Asymmetric DBS 1 Then Asymmetric DBS 2 | Baseline bilateral STN-DBS for 3 to 4 weeks, followed by asymmetric STN-DBS 1 (right STN-DBS amplitude reduced by 50%) for 3 to 4 weeks, followed by asymmetric STN-DBS 2 (left STN-DBS amplitude reduced by 50%) for 3 to 4 weeks. |
| FG001 | Bilateral DBS Then Asymmetric DBS 2 Then Asymmetric DBS 1 | Baseline bilateral STN-DBS for 3 to 4 weeks, followed by asymmetric STN-DBS 2 (left STN-DBS amplitude reduced by 50%) for 3 to 4 weeks, followed by asymmetric STN-DBS 1 (right STN-DBS amplitude reduced by 50%) for 3 to 4 weeks. |
| FG002 | Asymmetric DBS 1 Then Bilateral DBS Then Asymmetric DBS 2 | Asymmetric STN-DBS 1 (right STN amplitude reduced by 50%) for 3 to 4 weeks, followed by baseline bilateral STN-DBS for 3 to 4 weeks, followed by asymmetric STN-DBS 2 (left STN-DBS amplitude reduced by 50%) for 3 to 4 weeks. |
| FG003 | Asymmetric DBS 1 Then Asymmetric DBS 2 Then Bilateral DBS | Asymmetric STN-DBS 1 (right STN-DBS amplitude reduced by 50%) for 3 to 4 weeks, followed by asymmetric STN-DBS 2 (left STN-DBS amplitude reduced by 50%) for 3 to 4 weeks, followed by baseline bilateral STN-DBS for 3 to 4 weeks. |
| FG004 | Asymmetric DBS 2 Then Bilateral DBS Then Asymmetric DBS 1 | Asymmetric STN-DBS 2 (left STN-DBS amplitude reduced by 50%) for 3 to 4 weeks, followed by baseline bilateral STN-DBS for 3 to 4 weeks, followed by asymmetric STN-DBS 1 (right STN-DBS amplitude reduced by 50%) for 3 to 4 weeks. |
| FG005 | Asymmetric DBS 2 Then Asymmetric DBS 1 Then Bilateral DBS | Asymmetric STN-DBS 2 (left STN-DBS amplitude reduced by 50%) for 3 to 4 weeks, followed by asymmetric STN-DBS 1 (right STN-DBS amplitude reduced by 50%) for 3 to 4 weeks, followed by baseline bilateral STN-DBS for 3 to 4 weeks. |
| FG006 | Asymmetric DBS 1 (Open Label) | After the Study Phase (Randomized, Blinded Period) was completed, patients were offered to participate in an Open Label Phase in which they would be switched for at least 12 weeks to either the Asymmetric DBS 1 or the Asymmetric DBS 2 condition if it was associated with axial symptom improvement when compared to their baseline bilateral DBS condition. Out of the 22 patients initially enrolled, 17 opted to participate. Out of the 17 patients that opted to participate, 7 were switched to the Asymmetric DBS 1 condition: 50% reduction of right STN-DBS amplitude (voltage) |
| FG007 | Asymmetric DBS 2 (Open Label) | After the Study Phase (Randomized, Blinded Period) was completed, patients were offered to participate in an Open Label Phase in which they would be switched for at least 12 weeks to either the Asymmetric DBS 1 or the Asymmetric DBS 2 condition if it was associated with axial symptom improvement when compared to their baseline bilateral DBS condition. Out of the 22 patients initially enrolled, 17 opted to participate. Out of the 17 patients that opted to participate, 10 were switched to the Asymmetric DBS 2 condition: 50% reduction of left STN-DBS amplitude (voltage) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Study Phase (Randomized, Blinded Period) |
| |||||||||||||
| Open Label Phase |
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Different arms/groups/sequences are combined because all 22 study participants received all treatments in the randomized/blinded phase of the study. The subsequent open label phase was optional and based on the results of the randomized/blinded phase.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All Study Participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 in Gait Velocity | As measured during the 10-meter walk test. In this test, participants walk at their usual, regular pace over a total distance of 10 meters. The middle 6-meters (between the 2-meter and 8-meter marks) are timed to measure gait velocity during steady-state gait. | Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to report the changes associated with the 2 asymmetric conditions. | Posted | Least Squares Mean | Standard Error | m/s | Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2) |
|
Adverse event data were collected for 12-18 weeks (study duration per patient) plus at least 12 additional weeks for patients who opted for the open label phase after study completion.
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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 | Bilateral STN-DBS (Study Phase) | Bilateral (baseline) STN-DBS settings (During the randomized, blinded phase) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Treatment failure | Nervous system disorders | Systematic Assessment | Patient did not tolerate this condition due to either 1) increase of 30% or more in the baseline MDS-UPDRS or 2) increase of less than 30% in the baseline MDS-UPDRS that did not respond to compensatory increase in the levodopa equivalent daily dose. |
There were no dropouts. The study phase of the trial concluded after the 22nd patient completed participation. As established by the sample size calculation, the originally planned enrollment of 27 patients was not necessary.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karlo J Lizarraga, MD, MS / Assistant Professor of Neurology | University of Rochester | 585-341-7500 | karlo.lizarraga@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Oct 8, 2019 | Apr 15, 2020 | Prot_SAP_ICF_000.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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| Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2) |
| Change in Axial Motor Function (1) | As measured by the Mini-BESTest. The Mini-BESTest is a shorter version of the BESTest (Balance Evaluation Systems Test). It is a clinical and research tool to measure balance control. The Mini-BESTest has 14 items, scored from 0-2 each, so the minimum score is 0 and the maximum score is 28. Lower scores indicate worse balance control and higher scores indicate better balance control. | Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2) |
| Change in Axial Motor Function (2) | As measured by the UPDRS-PIGD sub-scale. The UPDRS-PIGD is the Postural Instability Gait Dysfunction (PIGD) sub-scale of the Unified Parkinson's Disease Rating Scale (UPDRS). It is a clinical and research tool to measure PIGD. The UPDRS-PIGD has 5 items, scored from 0-4 each, so the minimum score is 0 and the maximum score is 20. Lower scores indicate better PIGD and higher scores indicate worse PIGD. | Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2) |
| Change in Axial Motor Function (3) | As measured by the Freezing of Gait Questionnaire. The Freezing of Gait Questionnaire is a clinical and research tool to measure freezing of gait. It has 6 items, scored from 0-4 each, so the minimum score is 0 and the maximum score is 24. Lower scores indicate better and higher scores indicate worse freezing of gait, respectively. | Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2) |
| Change in Quantitative Gait Analysis (1) | Changes in gait velocity in m/s as measured by a quantitative gait analysis system (Zeno walkway). | Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2) |
| Change in Quantitative Gait Analysis (2) | Changes in step length in cm (mean, right, left) as measured by a quantitative gait analysis system (Zeno walkway). Step length difference = [right - left step length] | Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2) |
| Change in Quantitative Gait Analysis (3) | Step length ratio = [right step length] / [left step length] Step length symmetry = ([right - left step length] / [right + left step length]) | Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2) |
| Change in Quantitative Speech Analysis (1) | Changes in pitch in Hertz (Hz) as measured by the Praat software. | Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2) |
| Change in Quantitative Speech Analysis (2) | Changes in loudness in decibels (dB) as measured by the Praat software. | Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2) |
| Change in Quantitative Speech Analysis (3) | Changes in jitter measured in percentage by the Praat software. In this case, jitter is the percentage change in the stability of the frequency of speech tone (i.e. speech cycle-to-cycle frequency variation) | Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2) |
| Change in Quantitative Speech Analysis (4) | Changes in shimmer measured in percentage by the Praat software. In this case, shimmer is the percentage change in the stability of the amplitude of speech tone (i.e. speech cycle-to-cycle amplitude variation) | Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2) |
| Change in Quality of Life | As measured by the Total Score of the 39-item Parkinson's Disease Quality of Life Questionnaire (PDQ-39). The PDQ-39 is a clinical and research tool to measure quality of life in Parkinson's disease. It has 39 questions, which patients score as never (0% of the time), occasionally (25% of the time), sometimes (50% of the time), often (75% of the time) or always (100% of the time). The PDQ-39 Total Score or Summary Index is the average of the 39 questions, expressed. The minimum score is 0% (never) and the maximum score is 100% (always). Lower scores indicate better quality of life and higher scores indicate worse quality of life. | Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2) |
| Change in Select Cognitive Tasks | Left brain cognitive function: Hopkins Verbal Learning Test-Revised: Total recall trials 1-3 (0-36), delayed recall (0-12); Phonemic Verbal Fluency (0-no max); Semantic Verbal Fluency (Animal cue) (0-no max); Letter 1-back and 2-back working memory tasks (0-100%). Right brain cognitive function: Brief Visual Memory Test-Revised: Total recall trials 1-3 (0-36), delayed recall (0-12); Computerized landmark line bisection (-10 to 10); Spatial 1-back and 2-back working memory tasks (0-100%). Ranges in parentheses. Line bisection: closer to 0 is more accurate. For the rest: higher values are better | Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2) |
| 29184712 | Background | Lizarraga KJ, Luca CC, De Salles A, Gorgulho A, Lang AE, Fasano A. Asymmetric neuromodulation of motor circuits in Parkinson's disease: The role of subthalamic deep brain stimulation. Surg Neurol Int. 2017 Oct 24;8:261. doi: 10.4103/sni.sni_292_17. eCollection 2017. |
| 35156734 | Derived | Lizarraga KJ, Gnanamanogaran B, Al-Ozzi TM, Cohn M, Tomlinson G, Boutet A, Elias GJB, Germann J, Soh D, Kalia SK, Hodaie M, Munhoz RP, Marras C, Hutchison WD, Lozano AM, Lang AE, Fasano A. Lateralized Subthalamic Stimulation for Axial Dysfunction in Parkinson's Disease: A Randomized Trial. Mov Disord. 2022 May;37(5):1079-1087. doi: 10.1002/mds.28953. Epub 2022 Feb 13. |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Hand dominance | Laterality Index as measured by the Edinburgh inventory: Scale range is -100 (minimum) to 100 (maximum), -100 indicates complete left handedness and 100 indicates complete right handedness. | Median | Full Range | units on a scale |
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| Parkinson's disease duration | Median | Full Range | years |
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| Predominant motor symptom at onset | Count of Participants | Participants |
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| More affected hemibody at onset | Count of Participants | Participants |
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| Indication for STN-DBS surgery | Count of Participants | Participants |
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| Time since STN-DBS surgery | Median | Full Range | months |
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| Time between STN-DBS surgery and onset of axial dysfunction | Mean | Full Range | months |
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| More affected hemibody at enrollment | Count of Participants | Participants |
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| Levodopa equivalent daily dose | Median | Full Range | mg/day |
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| Baseline right STN-DBS type | Count of Participants | Participants |
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| Baseline right STN-DBS amplitude | Median | Full Range | Volts |
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| Baseline right STN-DBS frequency | Median | Full Range | Hertz |
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| Baseline right STN-DBS pulse width | Median | Full Range | Microseconds |
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| Baseline total electrical energy delivered (TEED) to the right STN | Formula: TEED = (Voltage)(Voltage)*(Pulse Width)*(Frequency) / (Impedance) | Median | Full Range | Joules/second |
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| Baseline left STN-DBS type | Count of Participants | Participants |
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| Baseline left STN-DBS amplitude | Median | Full Range | Volts |
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| Baseline left STN-DBS frequency | Median | Full Range | Hertz |
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| Baseline left STN-DBS pulse width | Median | Full Range | Microseconds |
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| Baseline total electrical energy delivered (TEED) to the left STN | Formula: TEED = (Voltage)(Voltage)*(Pulse Width)*(Frequency) / (Impedance) | Median | Full Range | Joules/second |
|
| Gait velocity | As measured during the 10-meter walk test. In this test, participants walk at their usual, regular pace over a total distance of 10 meters. The middle 6-meters (between the 2-meter and 8-meter marks) are timed to measure gait velocity during steady-state gait. | Mean | Full Range | m/s |
|
| MDS-UPDRS (total) | The MDS-UPDRS (Movement Disorders Society Unified Parkinson's Disease Rating Scale) is a clinical and research tool to measure symptoms and signs of Parkinson's disease. It has 4 parts: Part I (non-motor experiences of daily living), Part II (motor experiences of daily living), Part III (motor examination) and Part IV (motor complications). The MDS-UPDRS has a total of 60 items, scored from 0-4 each. The minimum score is 0 and the maximum score is 240. Lower scores indicate better and higher scores indicate worse symptoms and signs of Parkinson's disease, respectively. | Median | Full Range | units on a scale |
|
| MDS-UPDRS (motor) | The MDS-UPDRS (motor) is Part III of the Movement Disorders Society Unified Parkinson's Disease Rating Scale. It is a clinical and research tool to measure motor signs of Parkinson's disease. Part III of the MDS-UPDRS has 28 items, scored from 0-4 each, so the minimum score is 0 and the maximum score is 112. Lower scores indicate better and higher scores indicate worse motor signs of Parkinson's disease, respectively. | Median | Full Range | units on a scale |
|
| MDS-UPDRS (axial motor) | The MDS-UPDRS (axial motor) is composed of items 3.1 to 3.3a and 3.9 to 3.13 of the Part III of the Movement Disorders Society Unified Parkinson's Disease Rating Scale. It is a clinical and research tool to measure axial motor signs of Parkinson's disease. MDS-UPDRS (axial motor) has 8 items, scored from 0-4 each, so the minimum score is 0 and the maximum score is 32. Lower scores indicate better and higher scores indicate worse axial motor signs of Parkinson's disease, respectively. | Median | Full Range | units on a scale |
|
| Mini-BESTest score | The Mini-BESTest is a shorter version of the BESTest (Balance Evaluation Systems Test). It is a clinical and research tool to measure balance control. The Mini-BESTest has 14 items, scored from 0-2 each, so the minimum score is 0 and the maximum score is 28. Lower scores indicate worse balance control and higher scores indicate better balance control. | Median | Full Range | units on a scale |
|
| UPDRS-PIGD score | The UPDRS-PIGD is the Postural Instability Gait Dysfunction (PIGD) sub-scale of the Unified Parkinson's Disease Rating Scale (UPDRS). It is a clinical and research tool to measure PIGD. The UPDRS-PIGD has 5 items, scored from 0-4 each, so the minimum score is 0 and the maximum score is 20. Lower scores indicate better PIGD and higher scores indicate worse PIGD. | Median | Full Range | units on a scale |
|
| Freezing of gait questionnaire | The Freezing of Gait Questionnaire is a clinical and research tool to measure freezing of gait. It has 6 items, scored from 0-4 each, so the minimum score is 0 and the maximum score is 24. Lower scores indicate better and higher scores indicate worse freezing of gait, respectively. | Median | Full Range | units on a scale |
|
| Summary index of the PDQ-39 | The 39-item Parkinson's Disease Quality of Life Questionnaire (PDQ-39) is a clinical and research tool to measure quality of life in Parkinson's disease. It has 39 questions, which patients score as never (0% of the time), occasionally (25% of the time), sometimes (50% of the time), often (75% of the time) or always (100% of the time). The PDQ-39 Total Score or Summary Index is the average of the 39 questions. The minimum score is 0% (never) and the maximum score is 100% (always). Lower scores indicate better quality of life and higher scores indicate worse quality of life. | Median | Full Range | units on a scale |
|
| Select cognitive tasks | Left brain cognitive function: Hopkins Verbal Learning Test-Revised: Total recall trials 1-3 (0-36), delayed recall (0-12); Phonemic Verbal Fluency (0-no max); Semantic Verbal Fluency (Animal cue) (0-no max); Letter 1-back and 2-back working memory tasks (0-100%). Right brain cognitive function: Brief Visual Memory Test-Revised: Total recall trials 1-3 (0-36), delayed recall (0-12); Computerized landmark line bisection (-10 to 10); Spatial 1-back and 2-back working memory tasks (0-100%). Ranges in parentheses. Line bisection: closer to 0 is more accurate. For the rest: higher values are better | Two patients could not complete cognitive tasks due to language barrier. | Mean | Standard Deviation | units on a scale |
|
| OG001 |
| Asymmetric STN-DBS 1 |
50% reduction of right STN-DBS amplitude (voltage) |
| OG002 | Asymmetric STN-DBS 2 | 50% reduction of left STN-DBS amplitude (voltage) |
|
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| Secondary | Change in Motor Function | As measured by the MDS-UPDRS (Movement Disorders Society Unified Parkinson's Disease Rating Scale), which is a clinical and research tool to measure symptoms and signs of Parkinson's disease. It has 4 parts: I (non-motor experiences of daily living), II (motor experiences of daily living), III (motor exam) and IV (motor complications). The MDS-UPDRS has 60 items, scored from 0-4 each. The minimum score is 0 and the maximum score is 240. The MDS-UPDRS (motor) is Part III and measures motor signs. It has 28 items, scored from 0-4 each, so the minimum score is 0 and the maximum score is 112. The MDS-UPDRS (axial motor) is composed of items 3.1 to 3.3a and 3.9 to 3.13 of Part III of the MDS-UPDRS and measures axial motor signs. It has 8 items, scored from 0-4 each, so the minimum score is 0 and the maximum score is 32. In the MDS-UPDRS total, motor and axial motor sub-scales, lower scores indicate better symptoms/signs and higher scores indicate worse symptoms/signs, respectively. | Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2) |
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| Secondary | Change in Axial Motor Function (1) | As measured by the Mini-BESTest. The Mini-BESTest is a shorter version of the BESTest (Balance Evaluation Systems Test). It is a clinical and research tool to measure balance control. The Mini-BESTest has 14 items, scored from 0-2 each, so the minimum score is 0 and the maximum score is 28. Lower scores indicate worse balance control and higher scores indicate better balance control. | Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to report the changes associated with the 2 asymmetric conditions. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2) |
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| Secondary | Change in Axial Motor Function (2) | As measured by the UPDRS-PIGD sub-scale. The UPDRS-PIGD is the Postural Instability Gait Dysfunction (PIGD) sub-scale of the Unified Parkinson's Disease Rating Scale (UPDRS). It is a clinical and research tool to measure PIGD. The UPDRS-PIGD has 5 items, scored from 0-4 each, so the minimum score is 0 and the maximum score is 20. Lower scores indicate better PIGD and higher scores indicate worse PIGD. | Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2) |
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| Secondary | Change in Axial Motor Function (3) | As measured by the Freezing of Gait Questionnaire. The Freezing of Gait Questionnaire is a clinical and research tool to measure freezing of gait. It has 6 items, scored from 0-4 each, so the minimum score is 0 and the maximum score is 24. Lower scores indicate better and higher scores indicate worse freezing of gait, respectively. | Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2) |
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| Secondary | Change in Quantitative Gait Analysis (1) | Changes in gait velocity in m/s as measured by a quantitative gait analysis system (Zeno walkway). | Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions. | Posted | Least Squares Mean | Standard Error | m/s | Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2) |
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| Secondary | Change in Quantitative Gait Analysis (2) | Changes in step length in cm (mean, right, left) as measured by a quantitative gait analysis system (Zeno walkway). Step length difference = [right - left step length] | Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions. | Posted | Least Squares Mean | Standard Error | cm | Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2) |
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| Secondary | Change in Quantitative Gait Analysis (3) | Step length ratio = [right step length] / [left step length] Step length symmetry = ([right - left step length] / [right + left step length]) | Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions. | Posted | Least Squares Mean | Standard Error | ratio | Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2) |
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| Secondary | Change in Quantitative Speech Analysis (1) | Changes in pitch in Hertz (Hz) as measured by the Praat software. | Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions. | Posted | Least Squares Mean | Standard Error | Hz | Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2) |
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| Secondary | Change in Quantitative Speech Analysis (2) | Changes in loudness in decibels (dB) as measured by the Praat software. | Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions. | Posted | Least Squares Mean | Standard Error | dB | Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2) |
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| Secondary | Change in Quantitative Speech Analysis (3) | Changes in jitter measured in percentage by the Praat software. In this case, jitter is the percentage change in the stability of the frequency of speech tone (i.e. speech cycle-to-cycle frequency variation) | Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions. | Posted | Least Squares Mean | Standard Error | percentage change in speech tone freq. | Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2) |
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| Secondary | Change in Quantitative Speech Analysis (4) | Changes in shimmer measured in percentage by the Praat software. In this case, shimmer is the percentage change in the stability of the amplitude of speech tone (i.e. speech cycle-to-cycle amplitude variation) | Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions. | Posted | Least Squares Mean | Standard Error | percentage change in speech tone amplit. | Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2) |
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| Secondary | Change in Quality of Life | As measured by the Total Score of the 39-item Parkinson's Disease Quality of Life Questionnaire (PDQ-39). The PDQ-39 is a clinical and research tool to measure quality of life in Parkinson's disease. It has 39 questions, which patients score as never (0% of the time), occasionally (25% of the time), sometimes (50% of the time), often (75% of the time) or always (100% of the time). The PDQ-39 Total Score or Summary Index is the average of the 39 questions, expressed. The minimum score is 0% (never) and the maximum score is 100% (always). Lower scores indicate better quality of life and higher scores indicate worse quality of life. | Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2) |
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| Secondary | Change in Select Cognitive Tasks | Left brain cognitive function: Hopkins Verbal Learning Test-Revised: Total recall trials 1-3 (0-36), delayed recall (0-12); Phonemic Verbal Fluency (0-no max); Semantic Verbal Fluency (Animal cue) (0-no max); Letter 1-back and 2-back working memory tasks (0-100%). Right brain cognitive function: Brief Visual Memory Test-Revised: Total recall trials 1-3 (0-36), delayed recall (0-12); Computerized landmark line bisection (-10 to 10); Spatial 1-back and 2-back working memory tasks (0-100%). Ranges in parentheses. Line bisection: closer to 0 is more accurate. For the rest: higher values are better | Two patients could not complete cognitive tasks due to language barrier. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2) |
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| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Asymmetric STN-DBS 1 (Study Phase) | 50% reduction of right STN-DBS amplitude (voltage) (During the randomized, blinded phase) | 0 | 22 | 0 | 22 | 8 | 22 |
| EG002 | Asymmetric STN-DBS 2 (Study Phase) | 50% reduction of left STN-DBS amplitude (voltage) (During the randomized, blinded phase) | 0 | 22 | 0 | 22 | 3 | 22 |
| EG003 | Asymmetric STN-DBS 1 (Open Label Phase) | 50% reduction of right STN-DBS amplitude (voltage) (During the open label phase) | 0 | 7 | 0 | 7 | 1 | 7 |
| EG004 | Asymmetric STN-DBS 2 (Open Label Phase) | 50% reduction of left STN-DBS amplitude (voltage) (During the open label phase) | 0 | 10 | 0 | 10 | 2 | 10 |
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| Increase in levodopa equivalent daily dose | Nervous system disorders | Systematic Assessment | Patient required compensatory increase in levodopa equivalent daily dose in order to tolerate this condition (Increase of less than 30% in the baseline MDS-UPDRS that responded to compensatory increase in the levodopa equivalent daily dose) |
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Not provided
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| MDS-UPDRS (axial motor) |
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| Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to report the changes associated with the 2 asymmetric conditions. | Mixed Models Analysis | 0.778 | Holm-adjusted P-Value: 0.902 *MDS-UPDRS total for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS | Superiority |
| Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions. | Mixed Models Analysis | 0.039 | Holm-adjusted P-Value: 0.157 *MDS-UPDRS (motor) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS | Superiority |
| Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions. | Mixed Models Analysis | 0.451 | Holm-adjusted P-Value: 0.902 *MDS-UPDRS (motor) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS | Superiority |
| Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions. | Mixed Models Analysis | 0.111 | Holm-adjusted P-Value: 0.333 *MDS-UPDRS (axial motor) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS | Superiority |
| Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions. | Mixed Models Analysis | 0.005 | Holm-adjusted P-Value: 0.030 *MDS-UPDRS (axial motor) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS | Superiority |
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Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions. |
| Mixed Models Analysis |
| 0.067 |
Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS |
| Superiority |
|
Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions. |
| Mixed Models Analysis |
| 0.051 |
Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS |
| Superiority |
|
Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions. |
| Mixed Models Analysis |
| 0.024 |
Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS |
| Superiority |
| Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions. | Mixed Models Analysis | 0.750 | Holm-adjusted P-Value: 1.00 *Gait velocity for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS | Superiority |
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| Step length (left) |
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| Step length difference |
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| Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions. | Mixed Models Analysis | 0.117 | Holm-adjusted P-Value: 1.00 *Step length (mean) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS | Superiority |
| Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions. | Mixed Models Analysis | 0.145 | Holm-adjusted P-Value: 1.00 *Step length (right) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS | Superiority |
| Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions. | Mixed Models Analysis | 0.056 | Holm-adjusted P-Value: 1.00 *Step length (right) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS | Superiority |
| Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions. | Mixed Models Analysis | 0.151 | Holm-adjusted P-Value: 1.00 *Step length (left) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS | Superiority |
| Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions. | Mixed Models Analysis | 0.129 | Holm-adjusted P-Value: 1.00 *Step length (left) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS | Superiority |
| Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions. | Mixed Models Analysis | 0.698 | Holm-adjusted P-Value: 1.00 *Step length difference for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS | Superiority |
| Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions. | Mixed Models Analysis | 0.779 | Holm-adjusted P-Value: 1.00 *Step length difference for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS | Superiority |
|
| Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions. | Mixed Models Analysis | 0.976 | Holm-adjusted P-Value: 1.00 *Step length ratio for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS | Superiority |
| Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions. | Mixed Models Analysis | 0.859 | Holm-adjusted P-Value: 1.00 *Step length symmetry for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS | Superiority |
| Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions. | Mixed Models Analysis | 0.860 | Holm-adjusted P-Value: 1.00 *Step length symmetry for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS | Superiority |
|
| Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions. | Mixed Models Analysis | 0.883 | Holm-adjusted P-Value: 1.00 *Pitch (minimum) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS | Superiority |
| Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions. | Mixed Models Analysis | 0.071 | Holm-adjusted P-Value: 0.781 *Pitch (maximum) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS | Superiority |
| Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions. | Mixed Models Analysis | 0.327 | Holm-adjusted P-Value: 1.00 *Pitch (maximum) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS | Superiority |
|
| Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions. | Mixed Models Analysis | 0.861 | Holm-adjusted P-Value: 1.00 *Loudness (minimum) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS | Superiority |
| Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions. | Mixed Models Analysis | 0.411 | Holm-adjusted P-Value: 1.00 *Loudness (maximum) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS | Superiority |
| Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions. | Mixed Models Analysis | 0.997 | Holm-adjusted P-Value: 1.00 *Loudness (maximum) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS | Superiority |
| Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions. | Mixed Models Analysis | 0.684 | Holm-adjusted P-Value: 1.00 *Jitter for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS | Superiority |
| Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions. | Mixed Models Analysis | 0.712 | Holm-adjusted P-Value: 1.00 *Shimmer for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS | Superiority |
|
Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions. |
| Mixed Models Analysis |
| 0.216 |
Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS |
| Superiority |
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| Phonemic Verbal Fluency |
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| Semantic Verbal Fluency (Animal cue) |
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| Letter 1-Back Working Memory Task |
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| Letter 2-Back Working Memory Task |
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| Brief Visual Memory Test-Revised: RecallTrials 1-3 |
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| Brief Visual Memory Test-Revised: Delayed Recall |
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| Computerized landmark line bisection task |
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| Spatial 1-Back Working Memory Task |
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| Spatial 2-Back Working Memory Task |
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