Tolerability of Transcutaneous Vagal Nerve Stimulation | NCT07735234

NCT07735234

Overview

NCT ID: NCT07735234
Lead Sponsor: The University of Texas Health Science Center, HoustonOTHER
Official Title: Tolerability of Transcutaneous Auricular Vagus Nerve Stimulation in Pediatric Stroke Survivors 1Tolerability of Transcutaneous Auricular Vagus Nerve Stimulation in Pediatric Stroke Survivors 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
Interventions: transcutaneous auricular vagus nerve stimulation (taVNS)

Ages Eligible for Study: Child (0-17)Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.

Central Contacts: Stuart M Fraser, MDContact
Stuart.M.Fraser@uth.tmc.edu(713) 500-7142