Hypoxia-Ischemia, BrainNCT06168071
Transauricular Vagus Nerve Stimulation in Children
A study testing taVNS in people with Hypoxia-Ischemia, Brain, run by Washington University School of Medicine at 1 site in United States.
Trial 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?… Read more about this study
- Who is it for?
- Ages 7 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxia-Ischemia, Brain
- What is being tested?
- taVNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2023to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Admitted for clinical EEG for spell characterization at investigator's institution
Who cannot join
- known history of brain injury
- known history of bradycardia
- congenital heart disease
- pregnant
- pacemaker or wearable defibrillator
- undergoing active cancer treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
Official title: Safety, Tolerability and Neurophysiological Response of Transauricular Vagus Nerve Stimulation in Children Without Brain Injury
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
- Conditions
- Hypoxia-Ischemia, Brain
- Being tested
- taVNS
- Medical subject headings
- Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taVNSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| taVNS with EEG in healthy children | Experimental | 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. Receives: Device: taVNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Heart rate
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.
Measured: 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
Determined by continuous pulse oximeter. If oxygen saturation drops below 92% for more than 30 seconds, stimulation will stop.
Measured: 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)
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.
Measured: Baseline prior to stimulation, 15 minutes into the stimulation and immediately following the 30 minute stimulation.
Tolerability: Tolerance Questionnaire
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
Measured: Baseline prior to stimulation, 15 minutes into the stimulation and immediately following the 30 minute stimulation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start15 Nov 2023
- Primary completionMay 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxia-Ischemia, BrainStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alyssa Smith, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168071
- Sponsor's protocol ID
- 202307034
- Status last verified
- Aug 2026
- First submitted
- 28 Nov 2023
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Neurophysiological Response of Transauricular Vagus Nerve Stimulation in Children Without Brain Injury
- ClinicalTrials.gov ID
- NCT06168071
- Acronym / sponsor ID
- 202307034
- Conditions
- Hypoxia-Ischemia, Brain
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 13 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| taVNS with EEG in healthy children | Experimental | Device: taVNSThe 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. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Admitted for clinical EEG for spell characterization at investigator's institution
Key exclusion criteria (6 listed)
- known history of brain injury
- known history of bradycardia
- congenital heart disease
- pregnant
- pacemaker or wearable defibrillator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| taVNSRecently, 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. | Device | taVNS with EEG in healthy children |
Primary outcome
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.
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
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.
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)
Time frame: 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
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alyssa Smith, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing taVNS in people with Hypoxia-Ischemia, Brain, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.