RECRUITING

taVNS for Anxiety in ASD

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-04-04
Study Completion:2025-02-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06258590

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Ages 12-17
  2. * English speaking
  3. * Prior diagnosis of ASD using autism diagnostic observation schedule (ADOS)
  4. * Score \>24 on SCARED
  5. * IQ \>70
  6. * Have the capacity and ability to provide one's own assent, consent will be provided by legal guardian
  1. * Facial or ear pain or recent ear trauma.
  2. * Metal implant devices in the head, heart or neck.
  3. * History of brain surgery.
  4. * History of myocardial infarction or arrhythmia, bradycardia.
  5. * Acute exacerbation of a chronic respiratory disorder or acute COVID-related symptoms.
  6. * Active GI symptoms with a history of diabetes mellitus or history of gastroparesis secondary to diabetes mellitus.
  7. * Personal or family history of seizure or epilepsy or personal use of medications that substantially reduce seizure threshold (e.g., olanzapine, chlorpromazine, lithium).
  8. * Personal history of head injury, concussion, or self-report of moderate to severe traumatic brain injury.
  9. * Individuals suffering from frequent/severe headaches.
  10. * Individuals with a reported history of psychosis or mania, or individuals who are actively manic or psychotic.
  11. * Individuals who are catatonic or otherwise unable to participate in the informed consent process.
  12. * Moderate to severe alcohol or substance use disorder.
  13. * Pregnancy

Contacts and Locations

Study Contact

Stewart Cox, MD,PhD
CONTACT
843-243-7303
coxstew@musc.edu
Bashar Badran, PhD
CONTACT
badran@musc.edu

Study Locations (Sites)

Medical University of South Carolina
Charleston, South Carolina, 29425
United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-04
Study Completion Date2025-02-24

Study Record Updates

Study Start Date2024-04-04
Study Completion Date2025-02-24

Terms related to this study

Keywords Provided by Researchers

  • Brain stimulation
  • Transcutaneous auricular vagus nerve stimulation

Additional Relevant MeSH Terms

  • Autism Spectrum Disorder
  • Anxiety