fMRI Tracking taVNS in ASD

NCT06698328 | Completed

• 1 other identifier: Pro00140411
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autistic Spectrum Disorders

Keywords

Adolescents; Anxiety; Autism

Outcome Measures

Primary Outcomes (1)

• Number of participants experiencing adverse outcomes as measured by questionnaire

  Assessing adverse outcomes via qualitative questionnaire asking participants about experiences during stimulation and any consequences after stimulation.

  1 month of experimental at-home taVNS treatment

Secondary Outcomes (3)

• Dynamic Brain States Change Relative to ASD through fMRI

  fMRI imaging will be conducted at baseline and at the 1 month follow-up final visit

• Anxiety rating for participants using the generalized anxiety disorder -child scale

  Through study completion, up to 2 months

• Empagthic abilities as measured by the Toronto Empathy Questionnaire

  Through study completion, up to 2 months

Study Arms (2)

Active Vagus Nerve Stimulation

ACTIVE COMPARATOR

This active vagus nerve stimulation uses electrodes on the ear to be administered twice daily, seven days per week, for four weeks at-home.

Device: Transauricular Vagus Nerve Stimulation

Sham Stimulation

SHAM COMPARATOR

This sham nerve stimulation uses electrodes on the ear to be administered twice daily, seven days per week, for four weeks at-home.

Device: Sham Stimulation

Interventions

Transauricular Vagus Nerve Stimulation DEVICE

Mild non-invasive electrical stimulation to the vagus nerve using electrodes or "stickers" that adhere to the ear and the surrounding area.

Active Vagus Nerve Stimulation

Sham Stimulation DEVICE

Sham non-invasive electrical stimulation using electrodes or "stickers" that adhere to the ear and the surrounding area.

Sham Stimulation

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• MUSC COBRE in Neurodevelopment and its Disorders (CNDD) Pilot Projects Program (PPP): collaborator

Study Sites (1)

30 Bee Street

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Anxiety Disorders; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Xiaolong Peng

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Instructor-Faculty

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 21, 2024
• Study Start: February 10, 2025
• Primary Completion: February 2, 2026
• Study Completion: February 2, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

US (1)