Developing Brain Imaging Biomarkers to Quantify the Effects of At-home taVNS Treatment in ASD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Number of participants experiencing adverse outcomes as measured by questionnaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Transauricular Vagus Nerve Stimulation (Device)
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.
干预措施: Sham Stimulation (Device)
结局指标
主要结局
Number of participants experiencing adverse outcomes as measured by questionnaire
时间窗: 1 month of experimental at-home taVNS treatment
Assessing adverse outcomes via qualitative questionnaire asking participants about experiences during stimulation and any consequences after stimulation.
次要结局
- Dynamic Brain States Change Relative to ASD through fMRI(fMRI imaging will be conducted at baseline and at the 1 month follow-up final visit)
- Anxiety rating for participants using the generalized anxiety disorder -child scale(Through study completion, up to 2 months)
- Empagthic abilities as measured by the Toronto Empathy Questionnaire(Through study completion, up to 2 months)
研究者
Xiaolong Peng
Research Instructor-Faculty
Medical University of South Carolina