Transauricular Vagus Nerve Stimulation in Children

Not Applicable

• Conditions: Hypoxia-Ischemia, Brain
• Interventions: Device: taVNS

• Registration Number: NCT06168071
• Lead Sponsor: Washington University School of Medicine

Brief 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
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Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2023-11-15
• Study First Submitted: 2023-11-28
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-08
• Last Update Submitted: 2023-12-08
• Study First Posted: 2023-12-13
• Last Update Posted: 2023-12-13
• Primary Completion: 2024-11-15
• Study Completion: 2025-11-15

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
taVNS with EEG in healthy children	taVNS	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.

Primary Outcome Measures

Name	Time	Method
Safety: Heart rate	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.
Safety: Oxygen saturation	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.
Tolerability: Face, Legs, Activity, Cry, Consolability (FLACC)	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.
Tolerability: Tolerance Questionnaire	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

Trial Locations

Locations (1)

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States