By InvitationNot Applicable

Transauricular Vagus Nerve Stimulation in Children

United States10 participantsStarted 2023-11-15

Plain-language 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

Who can participate

Age range

7 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety: Heart rate

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

Safety: Oxygen saturation

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

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

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

Tolerability: Tolerance Questionnaire

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

Trial details

NCT IDNCT06168071

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05

View on ClinicalTrials.gov More Hypoxia-Ischemia, Brain trials

Plain-language summary

Who can participate

Age range

7 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Safety: Heart rate

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

Safety: Oxygen saturation

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

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

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

Tolerability: Tolerance Questionnaire

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