Efficacy of NEURO+ Attention Training: A Randomized, Controlled, Blinded, Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in ADHD symptoms with Quotient ADHD System assessment
研究概览
简要总结
This study evaluates the efficacy of the Neuro+ Attention Training System (Neuro+) in improving attention skills in children. Half of participants will receive the Neuro+ intervention for 10 weeks, while the other half will continue treatment as usual (TAU) for the same period. We expect those receiving the Neuro+ intervention to see significant improvements in ADHD symptoms relative to the TAU controls.
详细描述
Neuro+ a non-pharmacological intervention that targets the underlying neural signatures and cognitive deficits which are assumed to mediate attention pathways. Targeting those underlying areas could reduce ADHD symptoms and potentially lead to greater transfer and generalization to functioning in the classroom and every day life.
Neuro+ combines neurofeedback, biofeedback, and go/no-go training protocols embedded in a training video game to help develop and improve attention skills. The protocols function as follows:
Neurofeedback: Users wear a dry, wireless, easy-to-use EEG headset that interfaces with computer software to provide feedback on their level of brain activation, or focus. Users must focus in order to advance through the training game.
Motion-biofeedback: Accelerometers in the headset send data on users' movement to the training game, such that users must maintain complete control of their bodies and remain absolutely still in order to advance through the game and avoid costly point penalties.
Go/no-go training: To practice impulse control, users will be challenged with adaptive "go/no-go tasks," requiring them to quickly and accurately respond to target stimuli and ignore distractions, with the tasks becoming more difficult as the user improves.
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 (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 8 to 13 at the time of parental informed consent.
- •Confirmed ADHD diagnosis at clinic
- •No usage of ADHD drugs in past 30 days, or stable on current drug regimen for at least 30 days. Drugs include: Pre specified, oral psychostimulants, including ADDERALL XR® [mixed salts of a single-entity amphetamine product], VYVANSE® [lisdexamfetamine dimesylate], CONCERTA® [methylphenidate HCl], FOCALIN XR® [dexmethylphenidate HCl], RITALIN LA® [methylphenidate HCl extended-release], METADATE CD® [methylphenidate HCl, USP], or other FDA-approved equivalents.
- •Ability to follow written and verbal instructions (English)
- •Girls or Boys
- •Functioning at an age-appropriate level intellectually.
- •Ability to comply with all the testing and requirements.
排除标准
- •Current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as post-traumatic stress disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder, conduct disorder, or other symptomatic manifestations that in the opinion of the Investigator that may confound study data/assessments.
- •Motor condition that prevents game playing.
- •Recent history (within the past 6 months) of suspected substance abuse or dependence.
- •History of seizures (exclusive of febrile seizures), a tic disorder, significant tics, or a current diagnosis of Tourette's Disorder.
- •Taken part in a clinical trial within 30 days prior to screening.
- •Diagnosis of color blindness.
- •Regular use of psychoactive drugs that in the opinion of the Investigator may confound study data/assessments.
- •Any other medical condition that in the opinion of the Investigator may confound study data/assessments.
结局指标
主要结局
Change in ADHD symptoms with Quotient ADHD System assessment
时间窗: At screening and at final clinical visit within 1 week following intervention
Assessments to be conducted with the Quotient ADHD System
Change in assessment of ADHD symptoms with Conners 3-Parent rating scale
时间窗: At screening and at final clinical visit within 1 week following intervention
Assessments to be conducted with the Conners 3-Parent rating scale
Incidence of adverse events
时间窗: As reported by subjects at final clinical visit, which occurs within 1 week following intervention.
Self-reported incidence of adverse events
次要结局
- Self-reported convenience ratings of Neuro+ intervention(At final clinical visit, within 1 week following intervention)