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Transauricular Vagus Nerve Stimulation in Children

NCT06168071 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-12-31

No results posted yet for this study

Summary

The goal of this clinical trial is to learn about brain waves during transauricular vagus nerve stimulation (taVNS) in healthy children.

The main questions it aims to answer are:

* What is the safety, tolerability, and physiological response of taVNS in children?
* Does the electroencephalogram (EEG) change during taVNS?

Participants will

* undergo a brief titration session where taVNS will be titrated to below perceptual threshold
* receive one session of 30 minutes of taVNS
* undergo clinical EEG monitoring during taVNS
* Continuous cardiorespiratory monitoring via pulse oximetry and blood pressure every 5 minutes
* Answer tolerability questions before, during and after 30 minute taVNS session

Conditions

  • Hypoxia-Ischemia, Brain

Interventions

DEVICE

taVNS

Recently, implantable VNS received FDA approval for augmenting motor recovery from ischemic stroke-induced hemiplegia when used during standard physical and occupational therapy sessions. VNS is FDA-approved for epilepsy therapy in children and is used for generalized refractory epilepsy. VNS may be achieved through an implantable stimulator on the left vagus nerve in the carotid sheath, or transcutaneously through the auricular branch of the vagus nerve (taVNS). All participants will be fitted with the device by attaching adhesive contacts to the left ear. Stimulation sessions will occur once for 30 minutes. The investigators will obtain baseline measure, tolerability questionnaires, vital signs, and EEG data.

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Alyssa Smith, MD · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-15
Primary Completion
2026-05-31
Completion
2026-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06168071 on ClinicalTrials.gov