Stroke
Conditions
Keywords
childhood stroke
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.
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.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 21 Years
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability as assessed by the ability of the participant to complete the treatment protocol | From 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 extremity | Baseline, 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. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Contacts
CONTACTStuart M Fraser, MD
CONTACTMelika A Abrahams
PRINCIPAL_INVESTIGATORStuart M Fraser, MD
The University of Texas Health Science Center, Houston
Outcome results
None listed