Double-blind Randomized Placebo-controlled Trial of the Efficacy of the Apollo System for Children With ADHD
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Effect Size for Change in Behavioral Index of Interference Control
研究概览
简要总结
To determine the extent to which the Apollo System is effective in reducing symptomatology associated with ADHD.
详细描述
The objective of this project is to understand the potential therapeutic benefits of the Apollo System for children with ADHD. Using vibrational therapy, the Apollo System has been previously demonstrated to promote greater balance of the autonomic nervous system. Given the importance of the autonomic nervous system for modulating levels of physiological arousal and in-turn governing aspects of attention and self-regulation; a therapeutic approach to promote better balance of this system may be particularly beneficial for populations such as children with ADHD. Accordingly, using a double-blind randomized placebo-controlled design this investigation will assess the extent to which the Apollo System is effective in reducing symptomatology associated with ADHD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
Double blind, sham/placebo controlled trial.
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All individuals that agreed to participate will be selected on a first come, first serve basis. No individual will be turned down due to sex, race, or ethnicity. The following inclusion criteria exist for all participants:
- •Participants must be 8 years of age or older and under the age of
- •Participants must have diagnosed or suspected Attention Deficit Hyperactivity Disorder (ADHD).
- •Participants must have one of the following: 1) on the same treatment plan for over a year with minimal symptom relieve or alleviation, 2) tried two or more treatment approaches but is unable to meet treatment goals, 3) taking medication but still has symptoms, or 4) unwanted or uncontrollable side effects related to the medication.
- •Participants must have normal or corrected-to-normal vision in order to complete the cognitive task.
排除标准
- •The following exclusion criteria exist for all participants:
- •Lack of consent.
- •Participants cannot have started a new treatment within the last 30 days.
- •Participants cannot have a history of hydrocephalus, Autism Spectrum Disorder, Schizophrenia, Conduct disorder, Oppositional Defiant Disorder, active substance abuse, or be on a beta blocker.
- •Participants cannot have previously used the Apollo System.
研究组 & 干预措施
Commercial Apollo System Device
The active experimental group received the commercial Apollo System device.
干预措施: 8 weeks of home based use. (Device)
Sham Apollo System Device
The control experimental group received a sham/placebo device that is identical to the commercial Apollo System device but uses an ultra-low (i.e., effectively zero) frequency pattern of vibrations.
干预措施: 8 weeks of home based use. (Device)
结局指标
主要结局
Effect Size for Change in Behavioral Index of Interference Control
时间窗: Prior to and following the 8 week study protocol period.
At pre and posttest, participants will complete a version of the Eriksen flanker task. Response accuracy will be quantified within each congruency as the proportion of correct responses relative to the number of trials administered. The effect size of the change from pre-to-posttest in overall response accuracy will be considered as the primary outcome. Effect sizes will be computed per Arm and do not reflect comparisons or combinations across Arms/Groups using the repeated measures variance correction for Cohen's d (Lakens, 2013).
Change in ADHD symptomatology as assessed using the ADHD-5 Rating Scale
时间窗: Prior to and following the 8 week study protocol period.
At pre and posttest, the parents/guardians of participants will complete the ADHD-5 Rating Scale. The behaviors included in the survey are derived from the diagnostic criteria for ADHD established in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition. Scores are summated into inattentive and hyperactive-impulsive symptom domains and transformed into symptom percentile scores based upon normative data based on age and biological sex. Change in the overall ADHD percentile will be considered as the primary outcome. A more negative change would indicate a better outcome reflective of reduction in ADHD related symptomatology.
Effect Size for Change in Behavioral Index of Response Inhibition
时间窗: Prior to and following the 8 week study protocol period.
At pre and posttest, participants will complete a version of the go/nogo task. Response accuracy will be quantified as the proportion of correct responses relative to the number of trials administered for target stimulus trails and nogo stimulus trials separately. The effect size of the change from pre-to-posttest for response accuracy to the nogo condition will be considered as the primary outcome. Effect sizes will be computed per Arm and do not reflect comparisons or combinations across Arms/Groups using the repeated measures variance correction for Cohen's d (Lakens, 2013).
次要结局
未报告次要终点
研究者
Matthew B. Pontifex, Ph.D.
Associate Professor
Michigan State University