Tolerability of Transcutaneous Auricular Vagus Nerve Stimulation in Pediatric Stroke Survivors 1Tolerability of Transcutaneous Auricular Vagus Nerve Stimulation in Pediatric Stroke Survivors 1
The University of Texas Health Science Center, Houston
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
- Age range
- 13–21 years
- Sex
- All
- Healthy volunteers
- No
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 underwe…
Interventions
- Devicetranscutaneous auricular vagus nerve stimulation (taVNS)
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.
Location
- The University of Texas Health Science Center at HoustonHouston, Texas