An Eight-Week, Open Trial Pilot Investigation of Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- ADHD-IV Rating Scale (ADHD-RS)
研究概览
简要总结
This proposal seeks to obtain preliminary data on the potential efficacy, tolerability, and feasibility of trigeminal nerve stimulation (TNS) as a treatment for Attention-Deficit/Hyperactivity Disorder (ADHD). If successful, this open-label, exploratory, pilot study will provide a basis for a federal grant application and larger controlled trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •male and female youth age 9 to 14 years with Diagnostic and Statistical Manuel -IV (DSM-IV) ADHD, combined subtype as determined by Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS) and clinical interview
- •minimum scores of 12 on both the inattentive and hyperactive/impulsive subscales of the baseline ADHD-Rating Scale (ADHD-RS)S
- •Clinical Global Impression- Severity (CGI-S) score at baseline
- •no current medications with central nervous system (CNS) affects
- •parents able and willing to monitor proper use of the stimulation device and complete all required rating scales.
排除标准
- •impaired functioning to a degree that requires immediate initiation of ADHD medication in the opinion of the parents and/or investigator; 2) current diagnosis of pervasive developmental disorder or major depression.
- •history of lifetime psychosis or mania
- •current suicidality
- •history of seizure disorder, tic disorder, or head injury with loss of consciousness.
研究组 & 干预措施
trigeminal nerve stimulation
Open label treatment with trigeminal nerve stimulation in an 8-week trial.
干预措施: EMS 7500 Digital Muscle Stimulator (Device)
结局指标
主要结局
ADHD-IV Rating Scale (ADHD-RS)
时间窗: Baseline and Week 8.
A standard, frequently used, clinician completed measure of Diagnostic and Statistical Manual -IV (DSM-IV) ADHD symptoms. Scale ranges from 0 (best) to 54 (worst). Unit of Measure - units on a scale. Outcome value reflects change from baseline at endpoint (Week 8) in ADHD-RS.
次要结局
- Conners Global Index - Parent(Baseline and Week 8.)
- Clinical Global Impression - Improvement (CGI-I)(Week 8)
- Attention Network Task - Incongruent Reaction Time(Baseline and Week 8.)
研究者
James McGough
Professor of Clinical Psychiatry
University of California, Los Angeles