Back to search results
NCT06168071

Transauricular Vagus Nerve Stimulation in Children

Enrolling by Invitation
NAAges 7–18Interventional
Washington University School of Medicine
~10 participants
Updated 2025-12-31 on ClinicalTrials.gov
What's tested:taVNS

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety: Heart rate
Measured over Baseline and continuously for 30 minutes during study visit. It will be recorded and assessed every 5 minutes during 30 minute study visit.
+3 more outcomes measured

Conditions

Hypoxia-Ischemia, Brain

Where it's being run

1 sites across 1 states
Missouri1

Study leadership

  • Alyssa Smith, MD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Admitted for clinical EEG for spell characterization at investigator's institution

Exclusion

known history of brain injury
known history of bradycardia
congenital heart disease
pregnant
pacemaker or wearable defibrillator
undergoing active cancer treatment

What this trial measures

  • Safety: Heart rateBaseline 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 saturationBaseline 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 QuestionnaireBaseline 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