Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
10 participants
INTERVENTIONAL
2023-11-15
2026-07-31
Brief Summary
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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
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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taVNS with EEG in healthy children
The investigators will enroll 10 children between 7-18 years of age who are admitted to the hospital for EEG monitoring for spell characterization to receive one session of 30 minutes of taVNS. The investigators will titrate taVNS to below perceptual threshold of stimulation and objectively assess tolerability. The following parameters will be used for taVNS: frequency 25 Hz, pulse width 250 µs, and varying intensities from 0.5 milliampere (mA) to 2 mA. Intensity will be titrated to be a level below perceptual threshold in a patient. The participant will have continuous cardiorespiratory monitoring via pulse oximetry and blood pressure every 5 minutes. EEG data will be compared before, during and after taVNS.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* known history of bradycardia
* congenital heart disease
* pregnant
* pacemaker or wearable defibrillator
* undergoing active cancer treatment
7 Years
18 Years
ALL
Yes
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Alyssa Smith, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University in St. Louis
St Louis, Missouri, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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202307034
Identifier Type: -
Identifier Source: org_study_id