Transauricular Vagus Nerve Stimulation in Children
- Conditions
- Hypoxia-Ischemia, Brain
- 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
* 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 10
- Admitted for clinical EEG for spell characterization at investigator's institution
- known history of brain injury
- known history of bradycardia
- congenital heart disease
- pregnant
- pacemaker or wearable defibrillator
- undergoing active cancer treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Washington University in St. Louis
🇺🇸Saint Louis, Missouri, United States
Washington University in St. Louis🇺🇸Saint Louis, Missouri, United States