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NCT07735234
Tolerability of Transcutaneous Vagal Nerve Stimulation
Conditions: Stroke
Sex: All
Ages: 13 Years – 21 Years
Healthy volunteers: No
Phase: NA
Enrollment: 1
Sponsor: The University of Texas Health Science Center, Houston
Location: The University of Texas Health Science Center at Houston Houston Texas
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.
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.
Source: ClinicalTrials.gov (NCT07735234). StuddyBuddy aggregates publicly available trial information.