Developing Brain Imaging Biomarkers to Quantify the Effects of At-home taVNS Treatment in ASD
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
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)
• Have the capacity and ability to provide one's own assent, consent will be provided by legal guardian
Locations
United States
South Carolina
30 Bee Street
RECRUITING
Charleston
Contact Information
Primary
Nicole Cash
cashni@musc.edu
843-792-9502
Time Frame
Start Date: 2025-02-10
Estimated Completion Date: 2025-11-01
Participants
Target number of participants: 16
Treatments
Active_comparator: Active Vagus Nerve Stimulation
This active vagus nerve stimulation uses electrodes on the ear to be administered twice daily, seven days per week, for four weeks at-home.
Sham_comparator: Sham Stimulation
This sham nerve stimulation uses electrodes on the ear to be administered twice daily, seven days per week, for four weeks at-home.
Related Therapeutic Areas
Sponsors
Leads: Medical University of South Carolina
Collaborators: MUSC COBRE in Neurodevelopment and its Disorders (CNDD) Pilot Projects Program (PPP)