NCT06698328Completed
fMRI Tracking taVNS in ASD
Developing Brain Imaging Biomarkers to Quantify the Effects of At-home taVNS Treatment in ASD
Source: ClinicalTrials.gov · Last updated 5 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 16 (actual)
- First submitted
- 13 Nov 2024
- Start date
- 10 Feb 2025
- Primary completion date
- 2 Feb 2026
- Lead sponsor
- Medical University of South Carolina
- Diseases
- Autism
- NCT number
- NCT06698328
What you commit to
- Study type: Interventional
- Participants enrolled: 16
- From 10 Feb 2025 to the primary completion date, 2 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- 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
- Moderate to severe alcohol or substance use disorder
Other
- Facial/ear pain or recent ear trauma
- Individuals who are catatonic or otherwise unable to participate in the informed consent process
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 12 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 30 Bee Street Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.