Not Yet RecruitingNot Applicable

Tolerability of Transcutaneous Vagal Nerve Stimulation

United States1 participantsStarted 2026-07-30

Plain-language summary

The purpose of this study is to assess the feasibility and tolerability of transcutaneous auricular vagus nerve stimulation (taVNS) in childhood stroke survivors undergoing bi-manual occupational therapy.

Who can participate

Age range

13 Years – 21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Childhood stroke survivor - either arterial ischemic stroke or intracerebral hemorrhage. * Stroke must be childhood onset, defined as occurring day 29 of life to 18 years of age (per the American Heart Association's definition of childhood stroke) * 6 months or greater from stroke onset * Arm impairment, defined as pediatric stroke outcome measure of 1 or greater of affected arm. * Affected arm Fugl-Meyer score of 60 or lower. * Able to participate in occupational therapy sessions. Exclusion Criteria: * Craniectomy without replacement of bone flap. Patients who underwent craniectomy will need the bone flap reattached prior to participation. * Presence of cranial metal implants or implant device that could be affected by taVNS: cochlear implant, implanted brain stimulator, or programmable ventriculoperitoneal shunt.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Tolerability as assessed by the ability of the participant to complete the treatment protocol

Timeframe: From baseline to end of treatment (5 weeks after baseline)

Change in arm function as assessed by the Fugl-Meyer score of Upper extremity

Timeframe: Baseline, 1-week post therapy

Trial details

NCT IDNCT07735234

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-04

Contact for this trial

Stuart M Fraser, MD

(713) 500-7142 Stuart.M.Fraser@uth.tmc.edu

View on ClinicalTrials.gov More Stroke trials

Who can participate

Age range

13 Years – 21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.