Tolerability of Transcutaneous Vagal Nerve Stimulation for Childhood Stroke

This study is testing a device called transcutaneous auricular vagus nerve stimulation (taVNS) in children and young adults who have had a stroke. The goal is to see if taVNS is well-tolerated and can be used safely alongside occupational therapy to help improve arm function. Participants will be between 13 and 21 years old and have experienced a stroke between 29 days and 18 years of age, with some arm weakness. The main things the researchers are looking at are how well participants can complete the treatment and any changes in their arm function. The current recruitment status is unclear, and only one participant is planned for this study.

Study design: This is an interventional study with a planned enrollment of one participant. The phase of the study is not specified.
What's involved: You would have 2-hour therapy sessions, 3 times per week, for 4 weeks, totaling 12 occupational therapy sessions with stimulation after each visit. Each session involves 90 minutes of therapy.
Compensation: Not stated in the trial record.
Follow-up: Arm function will be assessed at baseline and again one week after the therapy ends.

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

Tolerability of Transcutaneous Vagal Nerve Stimulation

Not Yet Recruiting

NAAges 13–21InterventionalDevice feasibility

The University of Texas Health Science Center, Houston

~1 participants

Updated 2026-07-29 on ClinicalTrials.gov

What's tested:transcutaneous auricular vagus nerve stimulation (taVNS)

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

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

Measured over From baseline to end of treatment (5 weeks after baseline)

+1 more outcome measured

Conditions

Stroke

Where it's being run

1 sites across 1 states

Texas1

Study leadership

Stuart M Fraser, MD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston

Who to contact

Stuart M Fraser, MD

[email protected]

(713) 500-7142

Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime

Eligibility criteria

Inclusion

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

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.

What this trial measures

Tolerability as assessed by the ability of the participant to complete the treatment protocolFrom baseline to end of treatment (5 weeks after baseline)
Tolerability will be assessed by whether the single enrolled participant completes all 12 taVNS-paired occupational therapy sessions and the 1-week post-therapy assessment without withdrawal or a protocol deviation due to tolerability concerns. Completion will be determined using study attendance records, withdrawal documentation, and protocol-deviation records
Change in arm function as assessed by the Fugl-Meyer score of Upper extremityBaseline, 1-week post therapy
Upper extremity motor impairment will be assessed using the therapist-administered Upper Extremity Fugl-Meyer Assessment. The total score ranges from 0 to 66 points, with higher scores indicating better upper extremity motor function.

Trialytics