taVNS for Anxiety in ASD

NCT06258590 | Completed

• 1 other identifier: Pro00128238
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism Spectrum Disorder; Anxiety

Keywords

Brain stimulation; Transcutaneous auricular vagus nerve stimulation

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 stimualtion

  4 weeks during trial with 30 day follow-up to assess adverse effects

Secondary Outcomes (2)

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

  Testing occurs prior to testing, at two weeks, and following the 4 week trial, along wioth a 30-day post trial follow-up

• Empagthic abilities as measured by the Toronto Empathy Questionnaire

  Testing occurs prior to testing, at two weeks, and following the 4 week trial, along wioth a 30-day post trial follow-up

Study Arms (1)

tVNS

EXPERIMENTAL

All patients will receive at-home Transcutaneous auricular vagus nerve stimulation (taVNS) and assess the impact on multiple behavioral outcomes associated with ASD and anxiety. This is an open-label trial.

Device: Transcutaneous auricular vagus nerve stimulation

Interventions

Transcutaneous auricular vagus nerve stimulation DEVICE

Patients will receive non invasive vagus nerve stimulation via electrodes attached to the ear.

tVNS

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)
• Score \>24 on SCARED
• IQ \>70
• Have the capacity and ability to provide one's own assent, consent will be provided by legal guardian

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Anxiety Disorders

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: February 14, 2024
• Study Start: April 4, 2024
• Primary Completion: February 1, 2026
• Study Completion: March 25, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

US (1)