Ear stimulation for anxiety in autistic teens
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for the Treatment of Anxiety Comorbid With Autism Spectrum Disorder (ASD)
This study is testing if a new ear stimulation treatment can help reduce anxiety in autistic teens aged 12-17 while they learn to use it at home.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (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 | NCT06258590 on ClinicalTrials.gov |
What this trial studies
This pilot trial investigates the safety and feasibility of transcutaneous auricular vagus nerve stimulation (taVNS) as a nonpharmacological intervention for managing anxiety in adolescents with Autism Spectrum Disorder (ASD). Up to 10 participants aged 12-17 will be recruited from outpatient clinics at the Medical University of South Carolina (MUSC). Participants will learn to self-administer taVNS treatments at home twice daily for four weeks, with the study assessing changes in anxiety and other neuropsychiatric symptoms through questionnaires. The study aims to evaluate the effectiveness of this wearable treatment approach while ensuring it does not interfere with existing mental health care.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adolescents aged 12-17 with a prior diagnosis of Autism Spectrum Disorder and significant anxiety symptoms.
Not a fit: Patients with certain medical conditions, such as recent ear trauma or a history of seizures, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a new, non-invasive treatment option for managing anxiety in adolescents with ASD.
How similar studies have performed: Previous studies have shown that taVNS is safe and feasible, suggesting potential for success in this novel application for anxiety in ASD.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Facial or 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 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 suffering from frequent/severe headaches. * Individuals with a reported 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
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Stewart Cox, MD,PhD
- Email: coxstew@musc.edu
- Phone: 843-243-7303
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.