Non-invasive ear stimulation for managing autism symptoms
Developing Brain Imaging Biomarkers to Quantify the Effects of At-home taVNS Treatment in ASD
This study is testing if a new ear stimulation treatment can help teenagers with autism and anxiety feel better over four weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 12 Years to 17 Years |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT06698328 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on managing symptoms in adolescents with autism spectrum disorder (ASD) and co-occurring anxiety. Participants will undergo baseline evaluations, including MRI scans, before self-administering taVNS or a sham treatment at home for four weeks. The study aims to identify imaging biomarkers that track brain state changes during the treatment. Behavioral evaluations will be conducted before, during, and after the treatment period to assess any improvements.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 12-17 with a prior diagnosis of autism spectrum disorder and the ability to provide assent.
Not a fit: Patients with certain medical conditions, such as a history of seizures or significant ear trauma, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new non-invasive treatment option for managing symptoms of autism and anxiety in adolescents.
How similar studies have performed: While the use of taVNS is emerging, this specific application in ASD is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
Where this trial is running
Charleston, South Carolina
- 30 Bee Street — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Xiaolong Peng — Medical University of South Carolina
- Study coordinator: Nicole Cash
- Email: cashni@musc.edu
- Phone: 843-792-9502
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.