Autistic Spectrum DisordersNCT06698328
fMRI Tracking taVNS in ASD
A study testing Transauricular Vagus Nerve Stimulation in people with Autistic Spectrum Disorders, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to explore whether a non-invasive form of ear stimulation called transcutaneous auricular vagus nerve stimulation (taVNS) can manage symptoms in patients with autism spectrum disorder (ASD). Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Autistic Spectrum Disorders
- What is being tested?
- Transauricular Vagus Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2025to 2 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ages 12-17
- English speaking
- Prior diagnosis of ASD using autism diagnostic observation schedule (ADOS)
- Have the capacity and ability to provide one's own assent, consent will be provided by legal guardian
Who cannot join
- Facial/ear pain or recent ear trauma
- Metal implant devices in the head, heart, or neck
- History of brain surgery
- History of myocardial infarction or arrhythmia/bradycardia
- Acute exacerbation of a chronic respiratory disorder or acute COVID-related symptoms
- Active GI symptoms with a history of diabetes mellitus (DM) or gastroparesis secondary to DM
Show all 13Show fewer
- Personal or family history of seizure or epilepsy or personal use of medications that substantially reduce seizure threshold (e.g., olanzapine, chlorpromazine, lithium)
- Personal history of head injury, concussion, or self-report of moderate to severe traumatic brain injury
- Personal history of frequent/severe headaches
- Personal history of psychosis or mania, or individuals who are actively manic or psychotic
- Individuals who are catatonic or otherwise unable to participate in the informed consent process
- Moderate to severe alcohol or substance use disorder
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing Brain Imaging Biomarkers to Quantify the Effects of At-home taVNS Treatment in ASD
The purpose of this study is to explore whether a non-invasive form of ear stimulation called transcutaneous auricular vagus nerve stimulation (taVNS) can manage symptoms in patients with autism spectrum disorder (ASD). Additionally, this study also uses magnetic resonance imaging (MRI) to capture images of participants' brains and apply an image processing method called INSCAPE to track brain state changes during taVNS treatment in ASD. Investigators will recruit up to 16 participants with ASD.
Read the detailed description
In this study, the Investigators main goal is to establish and validate new imaging biomarkers for evaluating and tracking changes in functional networks and dynamic brain states that occur over 1-month transcutaneous auricular vagus nerve stimulation (taVNS) treatment in individuals with autism spectrum disorder (ASD) at home.
In this double-blinded sham-controlled clinical trial, Investigators will recruit up to 16 patients with ASD and co-occurring anxiety symptoms from the outpatient clinics at MUSC, SPARK, Epic, and social media (i.e., Project Rex, SCARO). Each participant will first receive the baseline behavior evaluation using a neuropsychiatric battery. Then, participants will have a high-resolution structural MRI scan and four runs of resting-state fMRI scans (~30-min in total) at MUSC 30 Bee Street Center for Biomedical Imaging. This will be followed by an in-person training session with the subject (and legal guardian if applicable), where they will learn how to self-administer taVNS and ask any pertinent questions. Participants will self-administer taVNS (or sham) at home twice daily for 4 weeks. At the end of 4 weeks, participants will have the post-taVNS MRI scanning and behavioral evaluation. Additionally, participants will also complete the behavioral evaluation virtually right after the 2-week treatment, and follow-up 1 and 4 weeks after the completion of treatment.
Aim 1. Identify dynamic imaging biomarkers capable of tracking the brain state changes of ASD throughout a one-month taVNS treatment at home.
Aim 2. Explore whether dynamic brain state measures derived from baseline can predict symptom improvement and response to taVNS treatment.
Results from this study may help to further optimize this taVNS therapy and lead to more effective treatment for ASD, as well as identify dynamic imaging biomarkers that can quantify and track symptom recovery in this unique population.
- Conditions
- Autistic Spectrum Disorders
- Being tested
- Transauricular Vagus Nerve Stimulation, Sham Stimulation
- Keywords
- Adolescents, Anxiety, Autism
- Medical subject headings
- Autism Spectrum Disorder, Anxiety Disorders, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transauricular Vagus Nerve StimulationDevice
Mild non-invasive electrical stimulation to the vagus nerve using electrodes or "stickers" that adhere to the ear and the surrounding area.
Sham StimulationDevice
Sham non-invasive electrical stimulation using electrodes or "stickers" that adhere to the ear and the surrounding area.
| Study group | Role | What they receive |
|---|---|---|
| Active Vagus Nerve Stimulation | Active comparator | This active vagus nerve stimulation uses electrodes on the ear to be administered twice daily, seven days per week, for four weeks at-home. Receives: Device: Transauricular Vagus Nerve Stimulation |
| Sham Stimulation | Sham comparator | This sham nerve stimulation uses electrodes on the ear to be administered twice daily, seven days per week, for four weeks at-home. Receives: Device: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants experiencing adverse outcomes as measured by questionnaire
Assessing adverse outcomes via qualitative questionnaire asking participants about experiences during stimulation and any consequences after stimulation.
Measured: 1 month of experimental at-home taVNS treatment
Secondary outcomes (3)
Dynamic Brain States Change Relative to ASD through fMRI
Participants will undergo two MRI scans looking at the changes in brain states. One scan will be prior to stimulation treatment and one scan will be after one month of stimulation treatment.
Measured: fMRI imaging will be conducted at baseline and at the 1 month follow-up final visit
Anxiety rating for participants using the generalized anxiety disorder -child scale
Assessing the impact of stimulation on GAD-child scale, where lower numbers (0=none, 4=extreme) show improved anxiety
Measured: Through study completion, up to 2 months
Empagthic abilities as measured by the Toronto Empathy Questionnaire
Assessing the participants change in the ability to identify the emotions of others using the TEQ, while a score of less than 45 indicating below average empathy levels, and a max score of 64
Measured: Through study completion, up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start10 Feb 2025
- Primary completion2 Feb 2026
- Study completion2 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autistic Spectrum DisordersStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- MUSC COBRE in Neurodevelopment and its Disorders (CNDD) Pilot Projects Program (PPP)
- Responsible party
- Principal investigator, Xiaolong Peng, Medical University of South Carolina
- Investigators
- Xiaolong Peng, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698328
- Sponsor's protocol ID
- Pro00140411
- Status last verified
- Feb 2026
- First submitted
- 13 Nov 2024
- Last updated
- 5 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Brain Imaging Biomarkers to Quantify the Effects of At-home taVNS Treatment in ASD
- ClinicalTrials.gov ID
- NCT06698328
- Acronym / sponsor ID
- Pro00140411
- Conditions
- Autistic Spectrum Disorders
- Keywords
- Adolescents, Anxiety, Autism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- MUSC COBRE in Neurodevelopment and its Disorders (CNDD) Pilot Projects Program (PPP)
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 2 Feb 2026 (actual)
- Study completion
- 2 Feb 2026 (actual)
- First posted
- 21 Nov 2024 (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 purpose of this study is to explore whether a non-invasive form of ear stimulation called transcutaneous auricular vagus nerve stimulation (taVNS) can manage symptoms in patients with autism spectrum disorder (ASD). Additionally, this study also uses magnetic resonance imaging (MRI) to capture images of participants' brains and apply an image processing method called INSCAPE to track brain state changes during taVNS treatment in ASD. Investigators will recruit up to 16 participants with ASD.
Detailed description
In this study, the Investigators main goal is to establish and validate new imaging biomarkers for evaluating and tracking changes in functional networks and dynamic brain states that occur over 1-month transcutaneous auricular vagus nerve stimulation (taVNS) treatment in individuals with autism spectrum disorder (ASD) at home.
In this double-blinded sham-controlled clinical trial, Investigators will recruit up to 16 patients with ASD and co-occurring anxiety symptoms from the outpatient clinics at MUSC, SPARK, Epic, and social media (i.e., Project Rex, SCARO). Each participant will first receive the baseline behavior evaluation using a neuropsychiatric battery. Then, participants will have a high-resolution structural MRI scan and four runs of resting-state fMRI scans (~30-min in total) at MUSC 30 Bee Street Center for Biomedical Imaging. This will be followed by an in-person training session with the subject (and legal guardian if applicable), where they will learn how to self-administer taVNS and ask any pertinent questions. Participants will self-administer taVNS (or sham) at home twice daily for 4 weeks. At the end of 4 weeks, participants will have the post-taVNS MRI scanning and behavioral evaluation. Additionally, participants will also complete the behavioral evaluation virtually right after the 2-week treatment, and follow-up 1 and 4 weeks after the completion of treatment.
Aim 1. Identify dynamic imaging biomarkers capable of tracking the brain state changes of ASD throughout a one-month taVNS treatment at home.
Aim 2. Explore whether dynamic brain state measures derived from baseline can predict symptom improvement and response to taVNS treatment.
Results from this study may help to further optimize this taVNS therapy and lead to more effective treatment for ASD, as well as identify dynamic imaging biomarkers that can quantify and track symptom recovery in this unique population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Vagus Nerve Stimulation | Active comparator | Device: Transauricular Vagus Nerve StimulationThis active vagus nerve stimulation uses electrodes on the ear to be administered twice daily, seven days per week, for four weeks at-home. |
| Sham Stimulation | Sham comparator | Device: Sham StimulationThis sham nerve stimulation uses electrodes on the ear to be administered twice daily, seven days per week, for four weeks at-home. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Ages 12-17
- English speaking
- Prior diagnosis of ASD using autism diagnostic observation schedule (ADOS)
- Have the capacity and ability to provide one's own assent, consent will be provided by legal guardian
Key exclusion criteria (13 listed)
- Facial/ear pain or recent ear trauma
- Metal implant devices in the head, heart, or neck
- History of brain surgery
- History of myocardial infarction or arrhythmia/bradycardia
- Acute exacerbation of a chronic respiratory disorder or acute COVID-related symptoms
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 |
|---|---|---|
| Transauricular Vagus Nerve StimulationMild non-invasive electrical stimulation to the vagus nerve using electrodes or "stickers" that adhere to the ear and the surrounding area. | Device | Active Vagus Nerve Stimulation |
| Sham StimulationSham non-invasive electrical stimulation using electrodes or "stickers" that adhere to the ear and the surrounding area. | Device | Sham Stimulation |
Primary outcome
Number of participants experiencing adverse outcomes as measured by questionnaire
Time frame: 1 month of experimental at-home taVNS treatment
Assessing adverse outcomes via qualitative questionnaire asking participants about experiences during stimulation and any consequences after stimulation.
3 secondary outcomes
Dynamic Brain States Change Relative to ASD through fMRI
Time frame: fMRI imaging will be conducted at baseline and at the 1 month follow-up final visit
Anxiety rating for participants using the generalized anxiety disorder -child scale
Time frame: Through study completion, up to 2 months
Empagthic abilities as measured by the Toronto Empathy Questionnaire
Time frame: Through study completion, up to 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 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. This study is not recruiting at the moment.
Xiaolong Peng principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transauricular Vagus Nerve Stimulation in people with Autistic Spectrum Disorders, run by Medical University of South Carolina 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 4 inclusion and 13 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: finished, as of the sponsor's last update on 5 Feb 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants experiencing adverse outcomes as measured by questionnaire (time frame: 1 month of experimental at-home taVNS treatment). 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 5 Feb 2026.