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.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06616831

At-Home taVNS - Stroke Rehab

Completed
NAAges 18–80InterventionalTreatment
Medical University of South Carolina
~5 participants
Updated 2026-08-13 on ClinicalTrials.gov
What's tested:Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired with Task-Specific Training

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants Dropped Out
Measured over 2 weeks
+3 more outcomes measured
Stroke
Stroke, Ischemic
Stroke Hemorrhagic

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.

  • Bashar Badran, PhD · PRINCIPAL_INVESTIGATOR · Medical University of South Carolina

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

18-80 years old with an ischemic or hemorrhagic stroke that occurred ≥6 months prior;
Ability to give consent;
Unilateral limb (left or right) weakness with Fugl Meyer-Upper Extremity Scale score of 19-53/60 points which indicates adequate arm/hand use for rehabilitation tasks;
active wrist flexion/extension ≥10° with active abduction/extension of thumb and at least 1 digit ≥10° to further assure ability to participate in rehabilitation tasks;
Passive range of motion in affected shoulder, elbow and wrist within 20 degrees of normal values.

Exclusion

Other concomitant neurological disorders affecting upper extremity motor function;
Presence of Dysphagia or aspiration difficulties;
Prior injury to vagus nerve;
Pregnancy;
Documented history of dementia before or after stroke;
Documented history of uncontrolled depression or psychiatric disorder either before or after stroke which could affect their ability to participate in the experiment;
Uncontrolled hypertension;
Botox injections within 4 weeks of the first day of rehabilitation therapy.
  • 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.