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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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The purpose of this study is to examine the feasibility and preliminary efficacy of using transcutaneous vagus nerve stimulation (tVNS) at home, to enhance cognitive recovery in patients with mild-moderate traumatic brain injury (TBI).
This is a single-blind, open-label pilot study to evaluate the feasibility and preliminary efficacy of remotely supervised, at-home delivery of tVNS in individuals with moderate to severe TBI during the post-acute recovery phase. Eligible participants will complete a 2-week tVNS intervention protocol at home. Mixed methods (quantitative and qualitative) will be used to evaluate outcomes. Eligible participants will be invited to initial baseline assessment and tVNS training session (Visit 1). Then, they will complete two weeks of at-home administration period. Lastly, they will return to a post- stimulation assessment (Visit 2). In the assessment sessions participants will complete tasks of set shifting and working memory, core executive functions, as well as complete surveys regarding fatigue, sleep, and overall quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Stimulation | Experimental | Active stimulation using trans auricular nerve stimulation device (tVNS), one hour a day for 14 days at home. Pre and post assessment occurring at day 0 and day 15. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Vagus Nerve Stimulation (tVNS) | Device | tVNS stimulation, one hour a day, for 14 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who successfully completed 75% of the sessions. | Recording the number of participant who completed at least 75% of the sessions out of the number of participants enrolled in the study. | Day 15 |
| Participant-Reported Acceptability of Home-Based tVNS Therapy | Completion of the Treatment Acceptability/Adherence Scale at baseline (day 0) and post stimulation assessment (day 15) | Day 0 and Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| N-Back task | In the N-Back Task, participants are presented a series of visual stimuli. They are asking for each stimulus whether is matches a stimulus n-trials before. For example, in a 2-back task, in which the trials consist of letters, participants have to decide whether the current letter is the same as the letter in the trial n-2. We will use a computerized version of this task. | Day 0 Baseline and Day 15 Post Stimulation Assessment |
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Inclusion Criteria:
Age 18-75 years.
Exclusion Criteria:
Acute medical issues requiring close physician or nursing monitoring.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shirley Ryan AbilityLab | Chicago | Illinois | 60611 | United States |
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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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| California Verbal Learning Test | The California Verbal Learning Test evaluates the ability to encode, recall, and recognize verbally presented information across multiple learning trials and delayed recall conditions. Participants are read multiple lists of words and asked to recall specific words at different time allotments. | Day 0 Baseline and Day 15 Post Stimulation Assessment |
| Trail Making Test A&B | Trail Making Part A requires participant to draw a line between circles containing numbers in ascending order. Part B requires participants to alternate drawing a line between ascending letters and numbers. The key measures are the time required to complete and the number of errors made in Part A and Part B. The test measures various aspects of cognition including attention, visual search, motor coordination, reasoning, and task switching. | Day 0 Baseline and Day 15 Post Stimulation Assessment |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |