At-Home taVNS for Stroke Rehabilitation
This study is testing a new way to help stroke survivors improve movement in their arm and hand. It uses a device that delivers mild electrical stimulation to your ear, called transcutaneous auricular vagal nerve stimulation (taVNS), at the same time as you do exercises to improve your arm and hand function. The goal is to see if this combination, done at home, is safe and practical for people who have had a stroke (ischemic or hemorrhagic) at least six months ago and have some weakness in one arm. Researchers want to see if people can easily use the device at home and if it helps improve their arm and hand movement. This study plans to enroll 5 participants.
- Study design
- This is an interventional study with a planned enrollment of 5 participants. It is not specified if it is randomized or blinded.
- What's involved
- You would complete 2 weeks of task-specific training paired with transcutaneous auricular vagal nerve stimulation, three times per week.
- Compensation
- Not stated in the trial record.
- Follow-up
- Feasibility, safety, and compliance will be measured at 2 weeks.
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At-Home taVNS - Stroke Rehab
At a glance
Conditions
NCT06616831
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Medical University of South Carolina
Charleston, South Carolinano site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Bashar Badran, PhD · PRINCIPAL_INVESTIGATOR · Medical University of South Carolina
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
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Inclusion
Exclusion
What this trial measures
- Number of Participants Dropped Out2 weeks
Dropout rates will be assessed over the course of the study.
- Adverse Events2 weeks
Any side effects or adverse events will be assessed.
- Mean Participant Compliance With Prescribed At-Home Sessions2 weeks
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).
- Feasibility of Independent Completion of At-Home Study Procedures2 weeks
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.