Clinical trial NCT06698328: fMRI Tracking taVNS in ASD
Official title: Developing Brain Imaging Biomarkers to Quantify the Effects of At-home taVNS Treatment in ASD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autistic Spectrum Disorders
Keywords: Adolescents
Anxiety
Autism
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: MUSC COBRE in Neurodevelopment and its Disorders (CNDD) Pilot Projects Program (PPP)
First posted: 2024-11-21
Enrollment: 16
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Facial/ear pain or recent ear trauma
* Metal implant devices in the head, heart, or neck
* History of brain surgery
* History of myocardial infarction or arrhythmia/bradycardia
* Acute exacerbation of a chronic respiratory disorder or acute COVID-related symptoms
* Active GI symptoms with a history of diabetes mellitus (DM) or gastroparesis secondary to DM
* Personal or family history of seizure or epilepsy or personal use of medications that substantially reduce seizure threshold (e.g., olanzapine, chlorpromazine, lithium)
* Personal history of head injury, concussion, or self-report of moderate to severe traumatic brain injury
* Personal history of frequent/severe headaches
* Personal history of psychosis or mania, or individuals who are actively manic or psychotic
* Individuals who are catatonic or otherwise unable to participate in the informed consent process
* Moderate to severe alcohol or substance use disorder
* Pregnancy

Primary outcomes:
measure: Number of participants experiencing adverse outcomes as measured by questionnaire
timeFrame: 1 month of experimental at-home taVNS treatment
Secondary outcomes:
measure: Dynamic Brain States Change Relative to ASD through fMRI
timeFrame: fMRI imaging will be conducted at baseline and at the 1 month follow-up final visit
measure: Anxiety rating for participants using the generalized anxiety disorder -child scale
timeFrame: Through study completion, up to 2 months
measure: Empagthic abilities as measured by the Toronto Empathy Questionnaire
timeFrame: Through study completion, up to 2 months
Other outcomes:
Locations:
city: Charleston
country: United States
facility: 30 Bee Street
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Xiaolong Peng
role: PRINCIPAL_INVESTIGATOR
References: