Tolerability of Transcutaneous Vagal Nerve Stimulation

N/ANot Yet RecruitingNCT07735234

The University of Texas Health Science Center, Houston1 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Stroke

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.

Eligibility

Sex: ALLMin age: 13 YearsMax age: 21 Years

Medical Language ↔ Plain English

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.

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: Baseline, 1-week post therapy

Secondary Outcomes

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

Time frame: 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

Central 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

Data from ClinicalTrials.gov

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