NCT06258590Completed
taVNS for Anxiety in ASD
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for the Treatment of Anxiety Comorbid With Autism Spectrum Disorder (ASD)
Source: ClinicalTrials.gov · Last updated 30 Mar 2026
Brief summary (registry, in English)
Investigators will recruit up to 10 patients with Anxiety comorbid with Autism Spectrum Disorder (ASD) from the outpatient clinics at MUSC. This pilot trial will be an open-label investigation of the safety and feasibility of transcutaneous auricular vagus nerve stimulation (taVNS) as a nonpharmacological wearable intervention used to manage anxiety and other neuropsychiatric symptoms at home, with patients/caretakers self-administering treatments. Each subject will undergo an initial in-person screening and be consented prior to participating in the study. This will be followed by an in-person training session with the subject (and caretaker if applicable), where they will learn how to self-administer taVNS and ask any pertinent questions. Participants will self-administer taVNS at home twice daily for 4 weeks. These treatments will not interfere with other aspects of their mental health care. Our investigators, over the prior 8 years, have demonstrated that taVNS is safe and feasible in the outpatient setting. Furthermore, investigators have recently demonstrated that taVNS is well tolerated and safely self-administered at home with remote monitoring. The investigators hypothesize that taVNS will be safe and feasible to administer at home in this new population. Results from this study may lead to further exploration of taVNS in this unique population.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 9 Jan 2024
- Start date
- 4 Apr 2024
- Primary completion date
- 1 Feb 2026
- Lead sponsor
- Medical University of South Carolina
- Diseases
- Autism
- NCT number
- NCT06258590
What you commit to
- Study type: Interventional
- Participants enrolled: 10
- From 4 Apr 2024 to the primary completion date, 1 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 or history of gastroparesis secondary to diabetes mellitus.
- 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.
- Individuals with a reported history of psychosis or mania, or individuals who are actively manic or psychotic.
- Moderate to severe alcohol or substance use disorder.
Other
- Facial or ear pain or recent ear trauma.
- Individuals suffering from frequent/severe headaches.
- 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)
- Score \>24 on SCARED
- IQ \>70
- 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 |
|---|---|---|---|
| Medical University of South Carolina 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.