This research study is looking to test a new form of ear stimulation for the treatment of anxiety symptoms in children with autism spectrum disorder (ASD) ages 12-17 who are verbal. The treatment being researched is a sticker that attaches to the outer part of the ear.

This stimulation method is called Trans Auricular Vagus Nerve Stimulation (TAVNS) and it has been used in many populations, including premature infants, and has been found to be a safe and durable potential method of treatment. It targets the Vagus nerve, which is a part of the parasympathetic nervous system. This system aids in calming the body during stressful situations. Our hope is that by stimulating this nerve that symptoms of anxiety can be reduced. The Vagus nerve has many branches but this study will only target the branch that extends to the ear. The stimulation device is a small handheld unit that uses an electrode or “sticker” to deliver mild noninvasive electrical stimulation to this nerve. It sticks to the part of the front of the ear known as the tragus, behind the ear, and just entering the part of the ear canal called the cymba. (You may see the electrode’s placement in the image in the flyer below.) This stimulation feels like a slight vibration or tickling sensation.

The study lasts four weeks and requires three in-person visits to MUSC’s downtown campus:

    • At the first visit, the parent and participating child meet with Dr. Frampton Gwynette to go over the consent forms so the process is fully understood.
    • At the second visit, both the child and parent answer questionnaires on a computer about their lives and symptoms. The child will also complete an emotion/empathy assessment, which is simply looking at pictures of faces on a computer and selecting the correct emotion that fits with the picture and rating their empathy with the person on the screen. The child will also complete an MRI. At the end of the visit, the child and parent will be taught how to use the stimulation device and undergo their first treatment with the study staff. A virtual follow-up meeting will take place at the two week mark.
    • The third and final visit occurs at the four week mark. At this meeting, the device is returned and consent forms are again reviewed to ensure full understanding. Four weeks after treatment, a set of follow up questionnaires will be sent to gauge the persistence of the treatment’s effects, if any, after it is discontinued

Compensation is provided for participation in this study.

If you are interested in participating, please call 843-792-9502 or send an email to Nicole Cash (cashni@musc.edu) or Falon Sutton (suttonf@musc.edu).

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