RECRUITING

FMRI Tracking TaVNS in ASD

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Conditions

Autistic Spectrum DisordersAdolescentsAnxietyAutism

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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

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.

Official Title

Developing Brain Imaging Biomarkers to Quantify the Effects of At-home TaVNS Treatment in ASD

Quick Facts

Study Start:2025-02-01
Study Completion:2025-11-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06698328

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. * Have the capacity and ability to provide one's own assent, consent will be provided by legal guardian
  1. * Facial/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 (DM) or gastroparesis secondary to DM
  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. * Personal history of frequent/severe headaches
  10. * Personal 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

Nicole Cash
CONTACT
843-792-9502
cashni@musc.edu

Principal Investigator

Xiaolong Peng
PRINCIPAL_INVESTIGATOR
Medical University of South Carolina

Study Locations (Sites)

30 Bee Street
Charleston, South Carolina, 29425
United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

  • Xiaolong Peng, PRINCIPAL_INVESTIGATOR, 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 Date2025-02-01
Study Completion Date2025-11-01

Study Record Updates

Study Start Date2025-02-01
Study Completion Date2025-11-01

Terms related to this study

Keywords Provided by Researchers

  • Adolescents
  • Anxiety
  • Autism

Additional Relevant MeSH Terms

  • Autistic Spectrum Disorders