fMRI Tracking taVNS in ASD

Completed · Not applicable · Has a placebo group

Conditions studied: Autistic Spectrum Disorders

In brief

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.

Key facts

Study ID

NCT06698328

Run by

Medical University of South Carolina

People needed

16

Starts

2025-02-10

Expected to finish

2026-02-02

Last updated by the study team

2026-02-05

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• 30 Bee Street — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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