Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for the Treatment of Anxiety Comorbid With Autism Spectrum Disorder (ASD)

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 17
Healthy Volunteers: f
View:

• 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

Locations
United States
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Contact Information
Primary
Stewart Cox, MD,PhD
coxstew@musc.edu
843-243-7303
Backup
Bashar Badran, PhD
badran@musc.edu
Time Frame
Start Date: 2024-04-04
Estimated Completion Date: 2026-02-24
Participants
Target number of participants: 10
Treatments
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Medical University of South Carolina

This content was sourced from clinicaltrials.gov