Transauricular Vagus Nerve Stimulation in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: taVNS.
- Who it may be relevant to
- Registry conditions: Hypoxia-Ischemia, Brain. Basic parameters: 7 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Safety, Tolerability and Neurophysiological Response of Transauricular Vagus Nerve Stimulation in Children Without Brain Injury
Overview
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
- 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
Primary outcome measures
- Safety: Heart rate [Time frame: 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 [Time frame: 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) [Time frame: Baseline prior to stimulation, 15 minutes into the stimulation and immediately following the 30 minute stimulation.]
- Tolerability: Tolerance Questionnaire [Time frame: Baseline prior to stimulation, 15 minutes into the stimulation and immediately following the 30 minute stimulation.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Washington University in St. Louis — St Louis
Identifiers
NCT: NCT06168071 · 202307034