Phase IIa Clinical Trial of External Trigeminal Nerve Stimulation for Autistic Children With Attention Deficit/Hyperactivity Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in ADHD Symptoms
研究概览
简要总结
The goal of this clinical trial is to learn if external trigeminal nerve stimulation (eTNS) works to treat ADHD symptoms in children on the autism spectrum (ASD). It will also learn about the efficacy and tolerability of the eTNS device. The main questions it aims to answer are:
- Does eTNS reduce ADHD symptoms?
- Does eTNS improve core and associated features of ASD?
Participation spans 8-12 weeks and includes:
- 4-5 in-person visits
- 4 brief virtual check-ins
- Nightly use of the eTNS device with a small sticky patch applied to child's forehead
- Randomized assignment (those who start with the sham device may try the active device later)
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 7 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed clinician diagnosis of ASD according to DSM-5 criteria, corroborated by prior testing (or obtained in study screening) with the Autism Diagnostic Observation Schedule (ADOS) with or without the Autism Diagnostic Interview-Revised (ADI-R)
- •IQ > 70 as corroborated by prior testing (or obtained in study screening) with the Wechsler Abbreviated Scale of Intelligence Scale (WASI)
- •Confirmed diagnosis of ADHD according to DSM-5 criteria with minimum ADHD-RS score of > 24
- •Stable on current medications for a minimum of 4 weeks before baseline
- •Ability to complete protocol testing
- •Both the child participant and their primary caregiver must be fluent in English (speaking, reading, and understanding), as the questionnaires and assessment tools used in this study have been validated only in English.
排除标准
- •Current major depression, history of psychosis, bipolar disorder, elevated risk of self-harm
- •History of moderate to severe coarse brain injury
- •Active medical illness expected to interfere with study assessments
- •Presence of implanted stimulator (e.g., vagal nerve stimulator)
- •Active dermatologic condition likely to interfere with eTNS electrode wearability
- •Sleep disorder likely to interfere with nightly eTNS in the opinion of the study physician
- •Inability to communicate discomfort or pain
- •Current and anticipated continued use of antipsychotic or stimulant medication
研究组 & 干预措施
Active eTNS Device
干预措施: Trigeminal Nerve Stimulation (Device)
Sham eTNS Device
干预措施: Sham Trigeminal Nerve Stimulation (Device)
结局指标
主要结局
Change in ADHD Symptoms
时间窗: Baseline to end of treatment at 6 weeks
Examine the efficacy of external Trigeminal Nerve Stimulation (eTNS) in reducing ADHD symptoms as measured by the Attention-Deficit/Hyperactivity Disorder Rating Scale-5 (ADHD-RS-5; range 0-54), where higher scores indicate worse symptoms.
次要结局
- Change in Social Responsiveness(Baseline to end of treatment at 6 weeks)
- Change in Restricted and Repetitive Behaviors(Baseline to end of treatment at 6 weeks)
- Change in Sleep Quality(Baseline to end of treatment at 6 weeks)
研究者
James T McCracken, M.D.
Deputy Vice Chair for Research-Child, Moghadam Family Distinguished Professor
University of California, San Francisco