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| Name | Class |
|---|---|
| Weill Medical College of Cornell University | OTHER |
| University of Utah | OTHER |
| Harvard Medical School (HMS and HSDM) | OTHER |
| The Cleveland Clinic |
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This study involves the treatment of cognitive impairment secondary to moderate to severe brain injury using central thalamic deep brain stimulation. Although all patients will receive stimulation continuously through a surgically implanted pacemaker-like device, half of the patients will have the device deactivated during a blinded assessment phase. The device will be reactivated following this assessment and patients will have the option to continue stimulation in an open-label continuation.
This preliminary safety study evaluates the use of the Medtronic Activa PC+S system and Medtronic Nexus-E system for central thalamic deep brain stimulation (CT-DBS) in the treatment of cognitive impairment secondary to traumatic brain injury (TBI). It involves a neurosurgical procedure in which electrodes are implanted in the brain, connected to an implanted pacemaker-like device in the chest. The proposed study, if successful, will provide supporting evidence for the development of a novel therapeutic approach utilizing CT-DBS to improve these enduring cognitive impairments arising in persons with multi-focal structural brain injuries. This research will address the critical gap of the lack of any available treatments. CT-DBS targets well-defined neuronal populations within the central thalamus that have known anatomical and physiological specializations, which not only provide a key role in arousal regulation during cognitively-mediated behaviors, but also exhibit a particular vulnerability to dysfunction in the setting of multi-focal, non-selective brain injuries.
Our proposed study aims to support development of CT-DBS as a novel therapeutic avenue for accessing cognitive reserve in patients with acquired brain injuries. In the proposed feasibility study of 6 subjects at a single investigational site, we will test the safety of CT-DBS in the severe traumatic brain injury (STBI) population with GOSE 6-7 level recovery and collect data to establish the translation of preclinical studies into human application of CT-DBS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Subjects will be treated with deep brain stimulation throughout the study, with the exception of a brief, 21 day blinded withdrawal phase that will be undertaken to assess for any possible therapeutic effect. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep brain stimulation | Device | Delivery of continuous, low-voltage electrical pulses to deep portions of the brain via an implantable pacemaker-like device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Trail Making Test Part B Time to Completion | The Trail Making Test is a measure of attention, speed and mental flexibility. It also tests spatial organization, visual pursuits, recall, and recognition. Part A requires the individual to draw lines to connect 25 encircled numbers distributed on a page. Part A tests visual scanning, numeric sequencing, and visuomotor speed. Part B is similar except the person must alternate between numbers and letters and is believed to be more difficult and takes longer to complete. Part B tests cognitive demands including visual motor and visual spatial abilities and mental flexibility. Both sections are timed and the score represents the amount of time required to complete the task. Lower scores (shorter times) correspond to a better outcome. | Pre-surgery baseline to treatment phase end (up to 197 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Trail Making Test Part A Time to Completion | The Trail Making Test is a measure of attention, speed and mental flexibility. It also tests spatial organization, visual pursuits, recall, and recognition. Part A requires the individual to draw lines to connect 25 encircled numbers distributed on a page. Part A tests visual scanning, numeric sequencing, and visuomotor speed. Part B is similar except the person must alternate between numbers and letters and is believed to be more difficult and takes longer to complete. Part B tests cognitive demands including visual motor and visual spatial abilities and mental flexibility. Both sections are timed and the score represents the amount of time required to complete the task. Lower scores (shorter times) correspond to a better outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaimie M Henderson, MD | Stanford University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Health Care | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9726257 | Background | Wilson JT, Pettigrew LE, Teasdale GM. Structured interviews for the Glasgow Outcome Scale and the extended Glasgow Outcome Scale: guidelines for their use. J Neurotrauma. 1998 Aug;15(8):573-85. doi: 10.1089/neu.1998.15.573. | |
| 38049620 | Derived | Schiff ND, Giacino JT, Butson CR, Choi EY, Baker JL, O'Sullivan KP, Janson AP, Bergin M, Bronte-Stewart HM, Chua J, DeGeorge L, Dikmen S, Fogarty A, Gerber LM, Krel M, Maldonado J, Radovan M, Shah SA, Su J, Temkin N, Tourdias T, Victor JD, Waters A, Kolakowsky-Hayner SA, Fins JJ, Machado AG, Rutt BK, Henderson JM. Thalamic deep brain stimulation in traumatic brain injury: a phase 1, randomized feasibility study. Nat Med. 2023 Dec;29(12):3162-3174. doi: 10.1038/s41591-023-02638-4. Epub 2023 Dec 4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Subjects were treated with deep brain stimulation throughout the study, with the exception of a brief, 21 day blinded withdrawal phase that was be undertaken to assess for any possible therapeutic effect. Deep brain stimulation: Delivery of continuous, low-voltage electrical pulses to deep portions of the brain via an implantable pacemaker-like device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hospital Admission and Surgery (3 Days) |
| |||||||||||||
| Post-surgical Washout (65 to 93 Days) |
| |||||||||||||
| DBS Titration-Optimization (14 Days) |
| |||||||||||||
| Unblinded Treatment Phase (90 Days) |
| |||||||||||||
| Withdrawal Phase (21 Days) |
| |||||||||||||
| Continuation Phase (6 Months) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Subjects were treated with deep brain stimulation throughout the study, with the exception of a brief, 21 day blinded withdrawal phase that was be undertaken to assess for any possible therapeutic effect. Deep brain stimulation: Delivery of continuous, low-voltage electrical pulses to deep portions of the brain via an implantable pacemaker-like device. |
| 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 | Percent Change in Trail Making Test Part B Time to Completion | The Trail Making Test is a measure of attention, speed and mental flexibility. It also tests spatial organization, visual pursuits, recall, and recognition. Part A requires the individual to draw lines to connect 25 encircled numbers distributed on a page. Part A tests visual scanning, numeric sequencing, and visuomotor speed. Part B is similar except the person must alternate between numbers and letters and is believed to be more difficult and takes longer to complete. Part B tests cognitive demands including visual motor and visual spatial abilities and mental flexibility. Both sections are timed and the score represents the amount of time required to complete the task. Lower scores (shorter times) correspond to a better outcome. | Subjects who completed all study assessments through the open label treatment phase | Posted | Median | Inter-Quartile Range | percent change in time | Pre-surgery baseline to treatment phase end (up to 197 days) |
|
1 year (treatment phase plus continuation phase)
Adverse events are presented in a single group because the study was designed to assess any adverse events during the study as a whole, not whether adverse events were associated with any particular study phase.
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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 | Treatment | Subjects will be treated with deep brain stimulation throughout the study, with the exception of a brief, 21 day blinded withdrawal phase that will be undertaken to assess for any possible therapeutic effect. Deep brain stimulation: Delivery of continuous, low-voltage electrical pulses to deep portions of the brain via an implantable pacemaker-like device. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection of DBS device | Infections and infestations | Systematic Assessment | Infection of deep brain stimulator system, requiring removal |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jaimie Henderson | Stanford University School of Medicine | +1 (650) 723-5574 | henderj@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 30, 2022 | Oct 11, 2022 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 3, 2022 | Sep 26, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| OTHER |
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|
| Pre-surgery baseline to treatment phase end (up to 197 days) |
| Percent Change in Traumatic Brain Injury Quality of Life - Executive Function Short Form (TBI-QOL) Scale Score | The TBI-QOL was developed as a comprehensive patient-reported outcomes (PRO) measurement system specifically for individuals with TBI. It consists of 20 independent calibrated item banks and 2 uncalibrated scales that measure physical, emotional, cognitive, and social aspects of health-related quality of life. We will administer the short form (6-10 questions each) of the TBI-QOL Fatigue, Attention/Concentration, and Executive Function subscales. Executive Function score range: 10-50, higher scores correspond to better executive function. | Pre-surgery baseline to treatment phase end (up to 197 days) |
| Percent Change Traumatic Brain Injury Quality of Life - Attention/Concentration Short Form Scale Score | The TBI-QOL was developed as a comprehensive patient-reported outcomes (PRO) measurement system specifically for individuals with TBI. It consists of 20 independent calibrated item banks and 2 uncalibrated scales that measure physical, emotional, cognitive, and social aspects of health-related quality of life. We will administer the short form (6-10 questions each) of the TBI-QOL Fatigue, Attention/Concentration, and Executive Function subscales. Attention/Concentration score range: 6-30, higher scores correspond to better attention and concentration. | Pre-surgery baseline to treatment phase end (up to 197 days) |
| Percent Change in Traumatic Brain Injury Quality of Life - Fatigue Short Form Scale Score | The TBI-QOL was developed as a comprehensive patient-reported outcomes (PRO) measurement system specifically for individuals with TBI. It consists of 20 independent calibrated item banks and 2 uncalibrated scales that measure physical, emotional, cognitive, and social aspects of health-related quality of life. We will administer the short form (6-10 questions each) of the TBI-QOL Fatigue, Attention/Concentration, and Executive Function subscales. Fatigue score range: 10-50, lower scores correspond to less fatigue. | Pre-surgery baseline to treatment phase end (up to 197 days) |
| Percent Change in Rivermead Post-Concussion Symptom Questionnaire Scale Score | The Rivermead PCS Questionnaire (RPQ) was originally developed as a measure of severity of symptoms following mild TBI. It consists of 16 post-concussion symptoms including headaches, dizziness, nausea/vomiting, noise sensitivity, sleep disturbance, fatigue, irritability, feeling depressed/tearful, feeling frustrated/ impatient, forgetfulness, poor concentration, taking longer to think, blurred vision, light sensitivity, double vision and restlessness. In the original version of the RPQ, participants are asked to rate the degree (on a scale of 0 to 4) to which a particular symptom has been absent or a mild, moderate or severe problem over the previous 24 hours compared with premorbid levels. Score range: 0-64, lower scores correspond to fewer symptoms | Pre-surgery baseline to treatment phase end (up to 197 days) |
| Percent Change in Ruff 2 and 7 Automatic Detection Speed Score | The Ruff 2 & 7 Test was developed to measure two aspects of visual attention: sustained attention (ability to maintain consistent performance level over time) and selective attention (ability to select relevant stimuli while ignoring distractors). The test consists of a series of 20 trials of a visual search and cancellation task. The respondent detects and marks through all occurrences of the two target digits: "2" and "7." In the 10 Automatic Detection trials, the target digits are embedded among alphabetical letters that serve as distractors. In the 10 Controlled Search trials, the target digits are embedded among other numbers that serve as distractors. Correct hits and errors are counted for each trial and serve as the basis for scoring the test. Speed scores reflect the total number of correctly identified targets (hits). Score range: 0 to 300, with higher numbers representing more correctly identified targets within the allotted time (5 minutes) | Pre-surgery baseline to treatment phase end (up to 197 days) |
| Percent Change in Ruff 2 and 7 Automatic Detection Accuracy Score | The Ruff 2 & 7 Test was developed to measure two aspects of visual attention: sustained attention (ability to maintain consistent performance level over time) and selective attention (ability to select relevant stimuli while ignoring distractors). The test consists of a series of 20 trials of a visual search and cancellation task. The respondent detects and marks through all occurrences of the two target digits: "2" and "7." In the 10 Automatic Detection trials, the target digits are embedded among alphabetical letters that serve as distractors. In the 10 Controlled Search trials, the target digits are embedded among other numbers that serve as distractors. Correct hits and errors are counted for each trial and serve as the basis for scoring the test. Accuracy scores evaluate the number of targets identified in relation to the number of possible targets (n=300), expressed as a percentage. Higher scores represent higher accuracy of target identification. | Pre-surgery baseline to treatment phase end (up to 197 days) |
| Percent Change in Ruff 2 and 7 Controlled Search Speed Score | The Ruff 2 & 7 Test was developed to measure two aspects of visual attention: sustained attention (ability to maintain consistent performance level over time) and selective attention (ability to select relevant stimuli while ignoring distractors). The test consists of a series of 20 trials of a visual search and cancellation task. The respondent detects and marks through all occurrences of the two target digits: "2" and "7." In the 10 Automatic Detection trials, the target digits are embedded among alphabetical letters that serve as distractors. In the 10 Controlled Search trials, the target digits are embedded among other numbers that serve as distractors. Correct hits and errors are counted for each trial and serve as the basis for scoring the test. Speed scores reflect the total number of correctly identified targets (hits). Score range: 0 to 300, with higher numbers representing more correctly identified targets within the allotted time (5 minutes) | Pre-surgery baseline to treatment phase end (up to 197 days) |
| Percent Change in Ruff 2 and 7 Controlled Search Accuracy Score | The Ruff 2 & 7 Test was developed to measure two aspects of visual attention: sustained attention (ability to maintain consistent performance level over time) and selective attention (ability to select relevant stimuli while ignoring distractors). The test consists of a series of 20 trials of a visual search and cancellation task. The respondent detects and marks through all occurrences of the two target digits: "2" and "7." In the 10 Automatic Detection trials, the target digits are embedded among alphabetical letters that serve as distractors. In the 10 Controlled Search trials, the target digits are embedded among other numbers that serve as distractors. Correct hits and errors are counted for each trial and serve as the basis for scoring the test. Accuracy scores evaluate the number of targets identified in relation to the number of possible targets (n=300), expressed as a percentage. Higher scores represent higher accuracy of target identification. | Pre-surgery baseline to treatment phase end (up to 197 days) |
| Percent Change in Patient Health Questionnaire - 9 Scale Score. | The Participant Health Questionnaire 9 is a standardized assessment instrument designed to screen, diagnose, monitor, and measure the severity of depression. Score range: 0 to 27, lower scores correspond to better health outcomes. | Pre-surgery baseline to treatment phase end (up to 197 days) |
| Number of Participants With ≥1 Point Increase in Glasgow Outcome Scale - Extended Scale Score | The Glasgow Outcome Scale Extended (GOS-E) is a measure of disability and handicap intended for use following head injury. The GOS-E subdivides the upper three categories of the original Glasgow Outcome Scale (GOS), severe disability, moderate disability and good recovery, into an eight-category scale: 1 = dead, 2 = vegetative state, 3 = lower severe disability, 4 = upper severe disability, 5 = lower moderate disability, 6 = upper moderate disability, 7 = lower good recovery, and 8 = upper good recovery to provide more detailed assessment of the functional effects of the injury. A structured interview has been developed to standardize assignment of an outcome category (Wilson et al. 1998). Increase of 1 point on this scale represents a meaningful change in health outcome. | Pre-surgery baseline to treatment phase end (up to 197 days) |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Years since injury | Median | Inter-Quartile Range | years |
|
| Years of education | Median | Inter-Quartile Range | years |
|
| Trail-making test, part B | This test requires the connection of circles marked by numbers and letters in alternating sequence and is considered a benchmark of executive function. The test score is the time required to complete the task in seconds. | Median | Inter-Quartile Range | seconds |
|
| Treatment |
Subjects were treated with deep brain stimulation throughout the study, with the exception of a brief, 21 day blinded withdrawal phase that was be undertaken to assess for any possible therapeutic effect. Deep brain stimulation: Delivery of continuous, low-voltage electrical pulses to deep portions of the brain via an implantable pacemaker-like device. |
|
|
| Secondary | Percent Change in Trail Making Test Part A Time to Completion | The Trail Making Test is a measure of attention, speed and mental flexibility. It also tests spatial organization, visual pursuits, recall, and recognition. Part A requires the individual to draw lines to connect 25 encircled numbers distributed on a page. Part A tests visual scanning, numeric sequencing, and visuomotor speed. Part B is similar except the person must alternate between numbers and letters and is believed to be more difficult and takes longer to complete. Part B tests cognitive demands including visual motor and visual spatial abilities and mental flexibility. Both sections are timed and the score represents the amount of time required to complete the task. Lower scores (shorter times) correspond to a better outcome. | Subjects who completed all study assessments through the open label treatment phase | Posted | Median | Inter-Quartile Range | percent change in time | Pre-surgery baseline to treatment phase end (up to 197 days) |
|
|
|
| Secondary | Percent Change in Traumatic Brain Injury Quality of Life - Executive Function Short Form (TBI-QOL) Scale Score | The TBI-QOL was developed as a comprehensive patient-reported outcomes (PRO) measurement system specifically for individuals with TBI. It consists of 20 independent calibrated item banks and 2 uncalibrated scales that measure physical, emotional, cognitive, and social aspects of health-related quality of life. We will administer the short form (6-10 questions each) of the TBI-QOL Fatigue, Attention/Concentration, and Executive Function subscales. Executive Function score range: 10-50, higher scores correspond to better executive function. | Subjects who completed all study assessments through the open label treatment phase | Posted | Median | Inter-Quartile Range | percent change in score | Pre-surgery baseline to treatment phase end (up to 197 days) |
|
|
|
| Secondary | Percent Change Traumatic Brain Injury Quality of Life - Attention/Concentration Short Form Scale Score | The TBI-QOL was developed as a comprehensive patient-reported outcomes (PRO) measurement system specifically for individuals with TBI. It consists of 20 independent calibrated item banks and 2 uncalibrated scales that measure physical, emotional, cognitive, and social aspects of health-related quality of life. We will administer the short form (6-10 questions each) of the TBI-QOL Fatigue, Attention/Concentration, and Executive Function subscales. Attention/Concentration score range: 6-30, higher scores correspond to better attention and concentration. | Subjects who completed all study assessments through the open label treatment phase | Posted | Median | Inter-Quartile Range | percent change in score | Pre-surgery baseline to treatment phase end (up to 197 days) |
|
|
|
| Secondary | Percent Change in Traumatic Brain Injury Quality of Life - Fatigue Short Form Scale Score | The TBI-QOL was developed as a comprehensive patient-reported outcomes (PRO) measurement system specifically for individuals with TBI. It consists of 20 independent calibrated item banks and 2 uncalibrated scales that measure physical, emotional, cognitive, and social aspects of health-related quality of life. We will administer the short form (6-10 questions each) of the TBI-QOL Fatigue, Attention/Concentration, and Executive Function subscales. Fatigue score range: 10-50, lower scores correspond to less fatigue. | Subjects who completed all study assessments through the open label treatment phase | Posted | Median | Inter-Quartile Range | percent change in score | Pre-surgery baseline to treatment phase end (up to 197 days) |
|
|
|
| Secondary | Percent Change in Rivermead Post-Concussion Symptom Questionnaire Scale Score | The Rivermead PCS Questionnaire (RPQ) was originally developed as a measure of severity of symptoms following mild TBI. It consists of 16 post-concussion symptoms including headaches, dizziness, nausea/vomiting, noise sensitivity, sleep disturbance, fatigue, irritability, feeling depressed/tearful, feeling frustrated/ impatient, forgetfulness, poor concentration, taking longer to think, blurred vision, light sensitivity, double vision and restlessness. In the original version of the RPQ, participants are asked to rate the degree (on a scale of 0 to 4) to which a particular symptom has been absent or a mild, moderate or severe problem over the previous 24 hours compared with premorbid levels. Score range: 0-64, lower scores correspond to fewer symptoms | Subjects who completed all study assessments through the open label treatment phase | Posted | Median | Inter-Quartile Range | percent change in score | Pre-surgery baseline to treatment phase end (up to 197 days) |
|
|
|
| Secondary | Percent Change in Ruff 2 and 7 Automatic Detection Speed Score | The Ruff 2 & 7 Test was developed to measure two aspects of visual attention: sustained attention (ability to maintain consistent performance level over time) and selective attention (ability to select relevant stimuli while ignoring distractors). The test consists of a series of 20 trials of a visual search and cancellation task. The respondent detects and marks through all occurrences of the two target digits: "2" and "7." In the 10 Automatic Detection trials, the target digits are embedded among alphabetical letters that serve as distractors. In the 10 Controlled Search trials, the target digits are embedded among other numbers that serve as distractors. Correct hits and errors are counted for each trial and serve as the basis for scoring the test. Speed scores reflect the total number of correctly identified targets (hits). Score range: 0 to 300, with higher numbers representing more correctly identified targets within the allotted time (5 minutes) | Subjects who completed all study assessments through the open label treatment phase | Posted | Median | Inter-Quartile Range | percent change in score | Pre-surgery baseline to treatment phase end (up to 197 days) |
|
|
|
| Secondary | Percent Change in Ruff 2 and 7 Automatic Detection Accuracy Score | The Ruff 2 & 7 Test was developed to measure two aspects of visual attention: sustained attention (ability to maintain consistent performance level over time) and selective attention (ability to select relevant stimuli while ignoring distractors). The test consists of a series of 20 trials of a visual search and cancellation task. The respondent detects and marks through all occurrences of the two target digits: "2" and "7." In the 10 Automatic Detection trials, the target digits are embedded among alphabetical letters that serve as distractors. In the 10 Controlled Search trials, the target digits are embedded among other numbers that serve as distractors. Correct hits and errors are counted for each trial and serve as the basis for scoring the test. Accuracy scores evaluate the number of targets identified in relation to the number of possible targets (n=300), expressed as a percentage. Higher scores represent higher accuracy of target identification. | Subjects who completed all study assessments through the open label treatment phase | Posted | Median | Inter-Quartile Range | percent change in score | Pre-surgery baseline to treatment phase end (up to 197 days) |
|
|
|
| Secondary | Percent Change in Ruff 2 and 7 Controlled Search Speed Score | The Ruff 2 & 7 Test was developed to measure two aspects of visual attention: sustained attention (ability to maintain consistent performance level over time) and selective attention (ability to select relevant stimuli while ignoring distractors). The test consists of a series of 20 trials of a visual search and cancellation task. The respondent detects and marks through all occurrences of the two target digits: "2" and "7." In the 10 Automatic Detection trials, the target digits are embedded among alphabetical letters that serve as distractors. In the 10 Controlled Search trials, the target digits are embedded among other numbers that serve as distractors. Correct hits and errors are counted for each trial and serve as the basis for scoring the test. Speed scores reflect the total number of correctly identified targets (hits). Score range: 0 to 300, with higher numbers representing more correctly identified targets within the allotted time (5 minutes) | Subjects who completed all study assessments through the open label treatment phase, and who had calculable scores | Posted | Median | Inter-Quartile Range | percent change in score | Pre-surgery baseline to treatment phase end (up to 197 days) |
|
|
|
| Secondary | Percent Change in Ruff 2 and 7 Controlled Search Accuracy Score | The Ruff 2 & 7 Test was developed to measure two aspects of visual attention: sustained attention (ability to maintain consistent performance level over time) and selective attention (ability to select relevant stimuli while ignoring distractors). The test consists of a series of 20 trials of a visual search and cancellation task. The respondent detects and marks through all occurrences of the two target digits: "2" and "7." In the 10 Automatic Detection trials, the target digits are embedded among alphabetical letters that serve as distractors. In the 10 Controlled Search trials, the target digits are embedded among other numbers that serve as distractors. Correct hits and errors are counted for each trial and serve as the basis for scoring the test. Accuracy scores evaluate the number of targets identified in relation to the number of possible targets (n=300), expressed as a percentage. Higher scores represent higher accuracy of target identification. | Subjects who completed all study assessments through the open label treatment phase, and who had calculable scores | Posted | Median | Inter-Quartile Range | percent change in score | Pre-surgery baseline to treatment phase end (up to 197 days) |
|
|
|
| Secondary | Percent Change in Patient Health Questionnaire - 9 Scale Score. | The Participant Health Questionnaire 9 is a standardized assessment instrument designed to screen, diagnose, monitor, and measure the severity of depression. Score range: 0 to 27, lower scores correspond to better health outcomes. | Subjects who completed all study assessments through the open label treatment phase | Posted | Median | Inter-Quartile Range | percent change in score | Pre-surgery baseline to treatment phase end (up to 197 days) |
|
|
|
| Secondary | Number of Participants With ≥1 Point Increase in Glasgow Outcome Scale - Extended Scale Score | The Glasgow Outcome Scale Extended (GOS-E) is a measure of disability and handicap intended for use following head injury. The GOS-E subdivides the upper three categories of the original Glasgow Outcome Scale (GOS), severe disability, moderate disability and good recovery, into an eight-category scale: 1 = dead, 2 = vegetative state, 3 = lower severe disability, 4 = upper severe disability, 5 = lower moderate disability, 6 = upper moderate disability, 7 = lower good recovery, and 8 = upper good recovery to provide more detailed assessment of the functional effects of the injury. A structured interview has been developed to standardize assignment of an outcome category (Wilson et al. 1998). Increase of 1 point on this scale represents a meaningful change in health outcome. | Subjects who completed all study assessments through the open label treatment phase | Posted | Count of Participants | Participants | Pre-surgery baseline to treatment phase end (up to 197 days) |
|
|
|
| 0 |
| 6 |
| 2 |
| 6 |
| 4 |
| 6 |
|
| Syncope | Nervous system disorders | Systematic Assessment | Syncope when standing to urinate |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Wound site bleeding | Surgical and medical procedures | Systematic Assessment | Scabbing at surgical site with small amount of bleeding |
|
| Unintended stimulator deactivation | Product Issues | Systematic Assessment | Stimulator de-activated unintentionally (felt to be due to theft detector in store) |
|
| Gait disturbance | Nervous system disorders | Systematic Assessment | Gait unsteadiness (self limited) |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Lower extremity pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Tinnitus | Nervous system disorders | Systematic Assessment |
|
| Cognitive difficulty | Nervous system disorders | Systematic Assessment | Difficulty with planning, organization and word recall |
|
| COVID-19 | Infections and infestations | Systematic Assessment |
|
Not provided
Not provided
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |