Pilot Explorations of Neurofeedback Issues in ADHD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Feasibility of Double-blind, Sham-controlled Design #1. Recruitment Number
研究概览
简要总结
Neurofeedback is increasingly advocated for treatment of ADHD despite a thin evidence base. The numerous open and partially controlled studies suffer serious design flaws. In particular, there is no published double-blind randomized clinical trial (RCT), which would control for experimenter and participant biases. The primary aim of this R34 pilot study is to conduct a small-scale pilot with 39 8-12 year-olds with ADHD to prepare for such a larger RCT.
详细描述
Thirty-nine boys and girls aged 6-12 with rigorously diagnosed DSM-IV ADHD not currently taking medication will be twice-randomized: first to active neurofeedback (n=26) vs. sham neurofeedback (n=13), and simultaneously to 2 vs. 3 times a week treatment frequency (at least 18 in each frequency, 12 active and 6 sham) for 40 treatments. At treatment 24, major assessments will include measures of satisfaction and blinding, and subjects will be given the option of switching to the opposite treatment frequency for the remaining 16 treatments to generate a practical measure of schedule palatability. Major assessments (at baseline, treatment 12, treatment 24, treatment 40, and follow-up) will include measures of symptoms, functional impairment, academic performance/achievement, and neuropsychological tests of attention, vigilance, and executive functioning. Every 3 treatments parents will rate ADHD symptoms and every 6 treatments teachers will rate, to track the response curve over time. Baseline EEG arousal and ADHD subtype will be examined as possible moderators. By determining the optimal frequency and number of treatments and demonstrating feasibility of double blinding, this pilot study should pave the way for a definitive large RCT of neurofeedback.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6-12 inclusive.
- •Boys and girls.
- •Primary diagnosis of ADHD, inattentive or combined type.
- •Not currently taking medication for ADHD.
- •Primary caretaker who can provide frequent parent ratings.
- •Item mean ≥1.5 on a 0-3 metric on parent/teacher ratings of DSM-IV inattentive symptoms or on parent/teacher ratings of all 18 ADHD symptoms (while off medication).
- •IQ 80 or above and mental age of 6 years or more.
- •Willingness and ability to come for 40 treatment sessions and to cooperate with assessments.
- •Informed consent and assent
排除标准
- •Comorbid disorder requiring psychoactive medication including psychosis, bipolar disorder, severe major depression, and severe anxiety disorders. Patients with mild depression or anxiety not requiring pharmacotherapy will be included and the comorbid symptoms will be tracked.Pervasive developmental disorder is exclusionary by DSM-IV definition of ADHD.
- •Medical disorder requiring systemic chronic medication that has confounding psychoactive effects. Asthma inhalants will be allowed, but not chronic systemic corticoids.
- •Mental Retardation.
- •Anything that would interfere with assessments or study treatment or contraindicate study treatment.
- •Plans to move requiring school change during the next 4 months.
- •Antipsychotic agent in the 6 months prior to baseline assessment, fluoxetine or atomoxetine in the 4 weeks prior to baseline, stimulant in the week prior to baseline, or other psychiatric medication in the two weeks prior to baseline.
- •Previous neurofeedback training of more than 5 treatments.
结局指标
主要结局
Feasibility of Double-blind, Sham-controlled Design #1. Recruitment Number
时间窗: 2 years
The feasibility of the double-blind, sham-controlled design was examined in 3 ways, this first way was via the number of participants recruited.
Necessary Duration of Treatment
时间窗: 40 treatment sessions ~ 13-20 weeks
The necessary duration of treatments was examined via identifying the number of treatments at which improvement stabilized, as shown visually on graphs of parent-rated ADHD symptoms from the SNAP-IV (0-3 scale, lower score is better) for those participants in the Active Neurofeedback who completed 40 treatment sessions.The Sham group is not included in this outcome.
Frequency Advisability Outcome (2X vs. 3X/wk) #2. Treatment Frequency Choice
时间窗: 24 treatments ~ 8-12 weeks
Treatment frequency preference when given choice to change or not to change treatment frequency from 2 to 3X/wk or 3 to 2X/wk at treatment # 24.
Feasibility of Double-blind, Sham-controlled Design #3. Validity of Blind
时间窗: Post-treatment at session 40
The feasibility of the double-blind, sham-controlled design was examined in 3 ways. The 3rd way was the percentage of child and parent post-hoc guess regarding treatment assignment.
Feasibility of Double-blind, Sham-controlled Design #2. Retention
时间窗: 40th treatment sessions ~ 13-20 weeks
The feasibility of the double-blind, sham-controlled design was examined in 3 ways. The second way was via the percentage of participants retained the end of treatment (40th session).
Frequency Advisability Outcome (2X vs. 3X/wk) #1 Parent & Child Satisfaction
时间窗: 24 treatments ~ 8-12 weeks
Parent \& child satisfaction of treatment frequency (x2 vs x3 treatments per week) was measured on a likert scale with anchors 0 (indicating low satisfaction) and 7 (indicating high satisfaction).
次要结局
未报告次要终点
研究者
L. Eugene Arnold
Professor Emeritus
Ohio State University