taVNS for Anxiety in ASD

NCT ID: NCT06258590

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-04
• Study Completion Date: 2026-02-24

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.

Detailed Description

This is a research study to find out if anxiety in patients with autism spectrum disorder are affected by a form of ear stimulation called transcutaneous auricular vagus nerve stimulation, or taVNS. Participants will learn how to self-administer ear stimulation treatments at home before starting the study. Over the course of a month, participants will self-administer ear stimulation treatments twice a day for a month. Each treatment will last up to 60 minutes (1 hour) and there will be a break of at least 30 minutes in between treatments. The study team will ask participants to complete a group of questionnaires at the beginning and end of the study. There will also be a smaller number of questionnaires completed electronically on a weekly basis. The questionnaires will ask questions about mental health symptoms that subjects may or may not be experiencing, including questions about mood, anxiety, and sleep.

Conditions

Autism Spectrum Disorder; Anxiety

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

tVNS

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.

Group Type: EXPERIMENTAL

Transcutaneous auricular vagus nerve stimulation

Intervention Type: DEVICE

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

Interventions

Transcutaneous auricular vagus nerve stimulation

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Stewart Cox, MD,PhD

Role: CONTACT

coxstew@musc.edu

843-243-7303

Bashar Badran, PhD

Role: CONTACT

badran@musc.edu

Facility Contacts

Frampton Gwynette, MD

Role: primary

gwynette@musc.edu

Stewart Cox, MD, PhD

Role: backup

coxstew@musc.edu

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro00128238

Identifier Type: -

Identifier Source: org_study_id