Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06168071

Transauricular Vagus Nerve Stimulation in Children

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

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Hypoxia-Ischemia, Brain Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hypoxia Hypoxia, Brain Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Admitted for clinical EEG for spell characterization at investigator's institution

Exclusion criteria

  • known history of brain injury
  • known history of bradycardia
  • congenital heart disease
  • pregnant
  • pacemaker or wearable defibrillator
  • undergoing active cancer treatment

Treatment and study plan

taVNS

Device

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.

Primary outcomes

  1. Safety: Heart rate

    Time frame: Baseline and continuously for 30 minutes during study visit. It will be recorded and assessed every 5 minutes during 30 minute study visit.

    Determined by continuous pulse oximeter. If heart rate drops below 60 beats per minute (bpm) in children younger than 9 years and below 50 bpm in children older than 9 years for more than 30 seconds, the stimulation will be stopped.

  2. Safety: Oxygen saturation

    Time frame: Baseline and continuously for 30 minutes during study visit. It will be recorded and assessed every 5 minutes during 30 minute study visit.

    Determined by continuous pulse oximeter. If oxygen saturation drops below 92% for more than 30 seconds, stimulation will stop.

  3. Tolerability: Face, Legs, Activity, Cry, Consolability (FLACC)

    Time frame: Baseline prior to stimulation, 15 minutes into the stimulation and immediately following the 30 minute stimulation.

    Observation pain assessment before, during and after stimulation. FLACC scale is a 0-10 pain scale with 10 being severe pain and 0 being no pain.

  4. Tolerability: Tolerance Questionnaire

    Time frame: Baseline prior to stimulation, 15 minutes into the stimulation and immediately following the 30 minute stimulation.

    Qualitative survey of side effects, ranking of preference of taVNS activity and 6-point comfort scale (6 being severely uncomfortable). Completed before, during and after stimulation

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Safety, Tolerability and Neurophysiological Response of Transauricular Vagus Nerve Stimulation in Children Without Brain Injury

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 13, 2023
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.