Tolerability of Transcutaneous Vagal Nerve Stimulation

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT07735234
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
13 Years - 21 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Jul 29, 2026
Start date
Jul 30, 2026
Status verified
Jul 2026
Primary completion
Sep 4, 2026
Completion
Sep 4, 2026

Study Design

Enrollment
1 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: transcutaneous auricular vagus nerve stimulation (taVNS)

Primary Outcome Measure

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Stuart M Fraser, MD
[email protected]
(713) 500-7142
Melika A Abrahams
[email protected]
(713) 500-6138

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Stroke
By specialty
NeurologyBrain disorders
By research site
The University of Texas Health Science Center at Houston· Houston, TX

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