Transauricular Vagus Nerve Stimulation in Children

NCT06168071 | Enrolling By Invitation

• 1 other identifier: 202307034
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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
• 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

Outcome Measures

Primary Outcomes (4)

• Safety: Heart rate

  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.

  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

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

  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)

  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.

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

• Tolerability: Tolerance Questionnaire

  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

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

Study Arms (1)

taVNS with EEG in healthy children

EXPERIMENTAL

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.

Device: taVNS

Interventions

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.

taVNS with EEG in healthy children

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

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

Study Officials

• Alyssa Smith, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 13, 2023
• Study Start: November 15, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

US (1)