Transauricular Vagus Nerve Stimulation in Children

Hypoxia-Ischemia, Brain Clinical Trial

Official title:

Safety, Tolerability and Neurophysiological Response of Transauricular Vagus Nerve Stimulation in Children Without Brain Injury

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06168071
• Other study ID #: 202307034
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: November 15, 2025

Study information

• Verified date: December 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: November 15, 2025
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Ischemia
• Hypoxia
• Hypoxia-Ischemia, Brain
• Ischemia

Intervention

Device:
• taVNS
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.

Locations

Country	Name	City	State
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.