Vagus Nerve Stimulation in Children

Overseen by Alyssa Smith, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Washington University School of Medicine

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

Research Team

Alyssa Smith, MD

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for healthy children who are undergoing clinical EEG at the investigator's institution to characterize spells. It excludes those with brain injury, heart issues like bradycardia or congenital heart disease, pregnancy, and those with a pacemaker or active cancer treatment.

Inclusion Criteria

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

Exclusion Criteria

Pregnant

Pacemaker or wearable defibrillator

I was born with a heart condition.

Treatment Details

Interventions

• Transauricular Vagus Nerve Stimulation (Behavioural Intervention)

Trial Overview The study tests transauricular vagus nerve stimulation (taVNS) in kids to see if it's safe and how their bodies respond. It looks at changes in brain waves during taVNS using an EEG while also monitoring heart rate and blood pressure.

Participant Groups

Group I: taVNS with EEG in healthy children Experimental Treatment 1 Intervention

The investigators will enroll 10 children between 7-18 years of age who are admitted to the hospital for EEG monitoring for spell characterization to receive one session of 30 minutes of taVNS. The investigators will titrate taVNS to below perceptual threshold of stimulation and objectively assess tolerability. The following parameters will be used for taVNS: frequency 25 Hz, pulse width 250 µs, and varying intensities from 0.5 milliampere (mA) to 2 mA. Intensity will be titrated to be a level below perceptual threshold in a patient. The participant will have continuous cardiorespiratory monitoring via pulse oximetry and blood pressure every 5 minutes. EEG data will be compared before, during and after taVNS.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+