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| Name | Class |
|---|---|
| MUSC COBRE in Neurodevelopment and its Disorders (CNDD) Pilot Projects Program (PPP) | UNKNOWN |
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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.
In this study, the Investigators main goal is to establish and validate new imaging biomarkers for evaluating and tracking changes in functional networks and dynamic brain states that occur over 1-month transcutaneous auricular vagus nerve stimulation (taVNS) treatment in individuals with autism spectrum disorder (ASD) at home.
In this double-blinded sham-controlled clinical trial, Investigators will recruit up to 16 patients with ASD and co-occurring anxiety symptoms from the outpatient clinics at MUSC, SPARK, Epic, and social media (i.e., Project Rex, SCARO). Each participant will first receive the baseline behavior evaluation using a neuropsychiatric battery. Then, participants will have a high-resolution structural MRI scan and four runs of resting-state fMRI scans (~30-min in total) at MUSC 30 Bee Street Center for Biomedical Imaging. This will be followed by an in-person training session with the subject (and legal guardian if applicable), where they will learn how to self-administer taVNS and ask any pertinent questions. Participants will self-administer taVNS (or sham) at home twice daily for 4 weeks. At the end of 4 weeks, participants will have the post-taVNS MRI scanning and behavioral evaluation. Additionally, participants will also complete the behavioral evaluation virtually right after the 2-week treatment, and follow-up 1 and 4 weeks after the completion of treatment.
Aim 1. Identify dynamic imaging biomarkers capable of tracking the brain state changes of ASD throughout a one-month taVNS treatment at home.
Aim 2. Explore whether dynamic brain state measures derived from baseline can predict symptom improvement and response to taVNS treatment.
Results from this study may help to further optimize this taVNS therapy and lead to more effective treatment for ASD, as well as identify dynamic imaging biomarkers that can quantify and track symptom recovery in this unique population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Vagus Nerve Stimulation | Active Comparator | This active vagus nerve stimulation uses electrodes on the ear to be administered twice daily, seven days per week, for four weeks at-home. |
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| Sham Stimulation | Sham Comparator | This sham nerve stimulation uses electrodes on the ear to be administered twice daily, seven days per week, for four weeks at-home. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transauricular Vagus Nerve Stimulation | Device | Mild non-invasive electrical stimulation to the vagus nerve using electrodes or "stickers" that adhere to the ear and the surrounding area. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants experiencing adverse outcomes as measured by questionnaire | Assessing adverse outcomes via qualitative questionnaire asking participants about experiences during stimulation and any consequences after stimulation. | 1 month of experimental at-home taVNS treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Dynamic Brain States Change Relative to ASD through fMRI | Participants will undergo two MRI scans looking at the changes in brain states. One scan will be prior to stimulation treatment and one scan will be after one month of stimulation treatment. | fMRI imaging will be conducted at baseline and at the 1 month follow-up final visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaolong Peng | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 30 Bee Street | Charleston | South Carolina | 29425 | United States |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D001008 | Anxiety Disorders |
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Sham Stimulation | Device | Sham non-invasive electrical stimulation using electrodes or "stickers" that adhere to the ear and the surrounding area. |
|
| Anxiety rating for participants using the generalized anxiety disorder -child scale |
Assessing the impact of stimulation on GAD-child scale, where lower numbers (0=none, 4=extreme) show improved anxiety |
| Through study completion, up to 2 months |
| Empagthic abilities as measured by the Toronto Empathy Questionnaire | Assessing the participants change in the ability to identify the emotions of others using the TEQ, while a score of less than 45 indicating below average empathy levels, and a max score of 64 | Through study completion, up to 2 months |