Transauricular Vagus Nerve Stimulation in Children

The Washington University

Status: Invitation-only

Conditions: Hypoxia-Ischemia, Brain

Treatments: Device: taVNS

Study type: Interventional

Funder types: Other

Identifiers

NCT06168071

202307034

Details and patient eligibility

About

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

Enrollment: 10 estimated patients

Sex: All

Ages: 7 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

taVNS with EEG in healthy children

Experimental group

Description:

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.

Treatment:

Device: taVNS