fMRI Tracking taVNS in ASD

Last updated: March 25, 2025
Sponsor: Medical University of South Carolina
Overall Status: Active - Recruiting

Phase

N/A

Condition

Asperger's Disorder

Williams Syndrome

Treatment

Sham Stimulation

Transauricular Vagus Nerve Stimulation

Clinical Study ID

NCT06698328
Pro00140411
  • Ages 12-17
  • All Genders

Study 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). 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.

Eligibility Criteria

Inclusion

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 providedby legal guardian

Exclusion

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 gastroparesissecondary to DM

  • Personal or family history of seizure or epilepsy or personal use of medicationsthat substantially reduce seizure threshold (e.g., olanzapine, chlorpromazine,lithium)

  • Personal history of head injury, concussion, or self-report of moderate to severetraumatic brain injury

  • Personal history of frequent/severe headaches

  • Personal history of psychosis or mania, or individuals who are actively manic orpsychotic

  • Individuals who are catatonic or otherwise unable to participate in the informedconsent process

  • Moderate to severe alcohol or substance use disorder

  • Pregnancy

Study Design

Total Participants: 16
Treatment Group(s): 2
Primary Treatment: Sham Stimulation
Phase:
Study Start date:
February 10, 2025
Estimated Completion Date:
November 01, 2025

Study 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.

Connect with a study center

  • 30 Bee Street

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

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