Trial Outcomes & Findings for At-Home taVNS - Stroke Rehab (NCT NCT06616831)
NCT ID: NCT06616831
Last Updated: 2026-08-13
Results Overview
Dropout rates will be assessed over the course of the study.
COMPLETED
NA
5 participants
2 weeks
2026-08-13
Participant Flow
Participant milestones
| Measure |
Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired With Task Specific Training
Task-specific training (TST) paired with EMG activated Transcutaneous Auricular Vagal Nerve Stimulation (taVNS) three times a week for two weeks in an At-Home setting.
Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired with Task-Specific Training: Each participant will complete 2 weeks, 3 times per week, task-specific training paired with transcutaneous auricular vagal nerve stimulation.
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Overall Study
STARTED
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5
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Overall Study
COMPLETED
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5
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
At-Home taVNS - Stroke Rehab
Baseline characteristics by cohort
| Measure |
Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired With Task Specific Training
n=5 Participants
Task-specific training (TST) paired with EMG activated Transcutaneous Auricular Vagal Nerve Stimulation (taVNS) three times a week for two weeks in an At-Home setting.
Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired with Task-Specific Training: Each participant will complete 2 weeks, 3 times per week, task-specific training paired with transcutaneous auricular vagal nerve stimulation.
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Age, Categorical
<=18 years
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0 Participants
n=1 Participants
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Age, Categorical
Between 18 and 65 years
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4 Participants
n=1 Participants
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Age, Categorical
>=65 years
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1 Participants
n=1 Participants
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Sex: Female, Male
Female
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2 Participants
n=1 Participants
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Sex: Female, Male
Male
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3 Participants
n=1 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=1 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=1 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=1 Participants
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Race (NIH/OMB)
Black or African American
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1 Participants
n=1 Participants
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Race (NIH/OMB)
White
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4 Participants
n=1 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=1 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=1 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=1 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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4 Participants
n=1 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=1 Participants
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Region of Enrollment
United States
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5 participants
n=1 Participants
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Motor Function- Fugl-Meyer Assessment
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41.4 FMA-UE score
STANDARD_DEVIATION 10.09 • n=1 Participants
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Motor Function- Wolf Motor Function
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42.6 Wolf Motor Function Test Score
STANDARD_DEVIATION 14.42 • n=1 Participants
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PRIMARY outcome
Timeframe: 2 weeksDropout rates will be assessed over the course of the study.
Outcome measures
| Measure |
Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired With Task Specific Training
n=5 Participants
Task-specific training (TST) paired with EMG activated Transcutaneous Auricular Vagal Nerve Stimulation (taVNS) three times a week for two weeks in an At-Home setting.
Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired with Task-Specific Training: Each participant will complete 2 weeks, 3 times per week, task-specific training paired with transcutaneous auricular vagal nerve stimulation.
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|---|---|
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Number of Participants Dropped Out
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0 Participants
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PRIMARY outcome
Timeframe: 2 weeksAny side effects or adverse events will be assessed.
Outcome measures
| Measure |
Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired With Task Specific Training
n=5 Participants
Task-specific training (TST) paired with EMG activated Transcutaneous Auricular Vagal Nerve Stimulation (taVNS) three times a week for two weeks in an At-Home setting.
Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired with Task-Specific Training: Each participant will complete 2 weeks, 3 times per week, task-specific training paired with transcutaneous auricular vagal nerve stimulation.
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|---|---|
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Adverse Events
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0 Adverse Events or side effects noted
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PRIMARY outcome
Timeframe: 2 weeksPopulation: At least 45 minutes of stimulation+therapy was completed per participant during virtual visits with study members and compliance was confirmed.
Compliance defined as the percentage of prescribed at-home transcutaneous auricular vagus nerve stimulation (taVNS) paired with task-specific training sessions completed by each participant during the 2-week intervention (6 sessions per participant).
Outcome measures
| Measure |
Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired With Task Specific Training
n=5 Participants
Task-specific training (TST) paired with EMG activated Transcutaneous Auricular Vagal Nerve Stimulation (taVNS) three times a week for two weeks in an At-Home setting.
Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired with Task-Specific Training: Each participant will complete 2 weeks, 3 times per week, task-specific training paired with transcutaneous auricular vagal nerve stimulation.
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Mean Participant Compliance With Prescribed At-Home Sessions
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100 percentage
Standard Deviation 0
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PRIMARY outcome
Timeframe: 2 weeksPopulation: Participants were evaluated during each supervised at-home session using a 3-point assistance scale. Scores were assigned as follows: 1 = no assistance required, 2 = minimal assistance required, and 3 = maximum assistance required to complete study procedures. Lower scores indicate greater participant independence and feasibility of at-home administration.
Feasibility was assessed during each remotely supervised at-home session using a 3-point assistance scale evaluating the participant's ability to independently complete study procedures at home. Ratings were assigned as follows: 1 = no assistance required, 2 = minimal assistance required, and 3 = maximum assistance required. Lower scores indicate greater participant independence and greater feasibility of at-home administration.
Outcome measures
| Measure |
Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired With Task Specific Training
n=5 Participants
Task-specific training (TST) paired with EMG activated Transcutaneous Auricular Vagal Nerve Stimulation (taVNS) three times a week for two weeks in an At-Home setting.
Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired with Task-Specific Training: Each participant will complete 2 weeks, 3 times per week, task-specific training paired with transcutaneous auricular vagal nerve stimulation.
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Feasibility of Independent Completion of At-Home Study Procedures
Virtual Visit 1
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1.6 scores on a scale
Standard Deviation 0.89
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Feasibility of Independent Completion of At-Home Study Procedures
Virtual Visit 2
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1.2 scores on a scale
Standard Deviation 0.45
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Feasibility of Independent Completion of At-Home Study Procedures
Virtual Visit 3
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0.45 scores on a scale
Standard Deviation 1.2
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Feasibility of Independent Completion of At-Home Study Procedures
Virtual Visit 4
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1 scores on a scale
Standard Deviation 0
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Feasibility of Independent Completion of At-Home Study Procedures
Virtual Visit 5
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1 scores on a scale
Standard Deviation 0
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Feasibility of Independent Completion of At-Home Study Procedures
Virtual Visit 6
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1 scores on a scale
Standard Deviation 0
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SECONDARY outcome
Timeframe: 2 weeksPopulation: All supervised at-home sessions completed by enrolled participants were included in the analysis. Feasibility was defined as meeting both prespecified criteria: completion of greater than 80% of prescribed motor rehabilitation activities and receipt of at least 45 minutes of stimulation during the session. A total of 30 supervised sessions were evaluated.
Feasibility was defined as the proportion of supervised at-home sessions that met both prespecified criteria: (1) completion of greater than 80% of prescribed motor rehabilitation activities and (2) receipt of at least 45 minutes of transcutaneous auricular vagus nerve stimulation during the session.
Outcome measures
| Measure |
Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired With Task Specific Training
n=30 Sessions
Task-specific training (TST) paired with EMG activated Transcutaneous Auricular Vagal Nerve Stimulation (taVNS) three times a week for two weeks in an At-Home setting.
Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired with Task-Specific Training: Each participant will complete 2 weeks, 3 times per week, task-specific training paired with transcutaneous auricular vagal nerve stimulation.
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Percentage of Supervised At-Home Sessions Meeting Prespecified Feasibility Criteria
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96.7 percentage of session
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SECONDARY outcome
Timeframe: 2 weeksPopulation: The Fugl-Meyer Assessment (FMA) Upper Extremity (UE) test was conducted for all participants at baseline and final. The highest score of 66 indicates normal motor function while the lowest score of 0 indicates extremely impaired motor function.
Motor function will be assessed in-person at baseline and at the end of the two-week intervention using the Fugl-Meyer Assessment (FMA).
Outcome measures
| Measure |
Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired With Task Specific Training
n=5 Participants
Task-specific training (TST) paired with EMG activated Transcutaneous Auricular Vagal Nerve Stimulation (taVNS) three times a week for two weeks in an At-Home setting.
Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired with Task-Specific Training: Each participant will complete 2 weeks, 3 times per week, task-specific training paired with transcutaneous auricular vagal nerve stimulation.
|
|---|---|
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Motor Function- Fugl-Meyer Assessment
Baseline Score
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41.4 FMA-UE score
Standard Deviation 10.09
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Motor Function- Fugl-Meyer Assessment
Final Score
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44.6 FMA-UE score
Standard Deviation 7.92
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SECONDARY outcome
Timeframe: 2-weeksPopulation: The Wolf Motor Function test was conducted for all participants at baseline and final. The highest score of 75 indicates normal motor function while the lowest score of 0 indicates extremely impaired motor function.
Motor function will be assessed in-person at baseline and at the end of the two-week intervention using the Wolf Motor Function Test.
Outcome measures
| Measure |
Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired With Task Specific Training
n=5 Participants
Task-specific training (TST) paired with EMG activated Transcutaneous Auricular Vagal Nerve Stimulation (taVNS) three times a week for two weeks in an At-Home setting.
Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired with Task-Specific Training: Each participant will complete 2 weeks, 3 times per week, task-specific training paired with transcutaneous auricular vagal nerve stimulation.
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|---|---|
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Motor Function- Wolf Motor Function
Baseline
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42.6 Wolf Motor Function Test Score
Standard Deviation 14.42
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Motor Function- Wolf Motor Function
Final
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44.0 Wolf Motor Function Test Score
Standard Deviation 12.94
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Adverse Events
Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired With Task Specific Training
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place