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Not yet recruiting NCT07735234

Tolerability of Transcutaneous Vagal Nerve Stimulation

No phase Interventional Stroke

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: transcutaneous auricular vagus nerve stimulation (taVNS).
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: 13 years — 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

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.

Interventions

  • Device transcutaneous 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 ses

Primary outcome measures

  • Tolerability as assessed by the ability of the participant to complete the treatment protocol [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 [Time frame: Baseline, 1-week post therapy]
Secondary outcome measures (1)
  • 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Device feasibility

Study locations

United States · 1 center
  • The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT07735234 · HSC-MS-25-0434

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗