Non-invasive Auricular Fiber Vagus Nerve Stimulation (afVNS) for Treatment of Autism Spectrum Disorder: An Open-Label Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility for completed treatments and stimulation intensity tolerance
研究概览
简要总结
Non-invasive vagus nerve stimulation for the symptomatic improvements in Autism Spectrum Disorder
详细描述
A single arm open-label study in Autism Spectrum Disorder (ASD) for evaluating treatment effects of non-invasive VNS, specifically auricular fiber vagal nerve stimulation (afVNS). A total of 20 patients diagnosed with ASD will be recruited to evaluate the feasibility of home healthcare application of afVNS and for assessment of short-term treatment effects on symptoms and comorbidities. ASD patients will receive 1 x hour per day afVNS treatment over 14 days with a fixed neuromodulation protocol. The primary outcome measure is feasibility assessed from completion success and neurostimulation tolerance. Secondary outcome measures include changes in scores pre- and post- afVNS treatment for Clinician Global Clinical Impression (CGI-I), Clinician Global Impression Severity (CGI-S), Children's Anxiety Sensitivity Index (CASI-R), Parent-Rated Anxiety Scale for ASD (PRAS-ASD), Autistic Behavior Checklist (ABC), Cleveland Adolescent Sleep Questionnaire (CASQ), verbal fluency and biomarker measures in autonomic physiology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 26 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Age: between 7 and 26 years
- •Participants and parent/ guardian must have proficiency in English
- •Diagnosis of ASD as defined by ADOS-2 or DSM-5 criteria
排除标准
- •Severe psychiatric disorders (e.g. bipolar, major depressive disorder)
- •Severe neurological disorders (e.g. stroke, epilepsy)
- •Bradyarrhythmia
- •History of head trauma (surgery or tumor)
- •Active medical implants (cochlear, VNS or pacemakers)
- •Cerebral shunts
- •Auricular skin disease that compromises placement of electrodes
- •Pregnancy
结局指标
主要结局
Feasibility for completed treatments and stimulation intensity tolerance
时间窗: 2 weeks
Completion success and neurostimulation tolerance
次要结局
- Clinician Global Clinical Impression (CGI-I)(2 weeks)
- Clinician Global Impression Severity (CGI-S)(2 weeks)
- Parent-Rated Anxiety Scale for ASD (PRAS-ASD)(2 weeks)
- Autistic Behavior Checklist (ABC) scores(2 weeks)