Hypoxia-Ischemia, Brain
Conditions
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
Interventions
DEVICEtaVNS
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.
Sponsors
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAlyssa Smith, MD
Washington University School of Medicine
Outcome results
None listed