Tolerability of Transcutaneous Vagal Nerve Stimulation

NCT07735234 | Not Yet Recruiting FDA Device

• 1 other identifier: HSC-MS-25-0434
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Keywords

childhood stroke

Outcome Measures

Primary Outcomes (2)

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

  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

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

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

  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.

  Baseline, 1-week post therapy

Secondary Outcomes (1)

• Change in tolerability as assessed by the number of side effects that occur as documented on the stimulation monitoring sheet

  Pre and immediately post stimulation on day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10, day 11 and day 12

Study Arms (1)

transcutaneous auricular vagus nerve stimulation (taVNS)

EXPERIMENTAL

Device: transcutaneous auricular vagus nerve stimulation (taVNS)

Interventions

transcutaneous auricular vagus nerve stimulation (taVNS) DEVICE

The participant will undergo 2-hour therapy sessions, 3 times per week, for 4 weeks for a total of 12 occupational therapy sessions with stimulation after the visit. Participants will receive 90 minutes of therapy per session. Stimulation will be delivered using a biphasic rectangular pulse, pulse width of 250 us, frequency of 25Hz, duty cycle of 30 seconds on / 30 seconds off during active therapy. 1 second ramp up and ramp down will be used to improve comfort. Maximum total stimulation per session will not exceed 45 minutes.

transcutaneous auricular vagus nerve stimulation (taVNS)

Eligibility Criteria

• Age: 13 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Stuart M Fraser, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stuart M Fraser, MD

CONTACT

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

Melika A Abrahams

CONTACT

(713) 500-6138; Melika.A.Abrahams@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 29, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): September 4, 2026
• Study Completion (Estimated): September 4, 2026
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)