Neurophysiological Attention Test (NAT) for Objective Assessment of Adult ADHD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 258
- 试验地点
- 3
- 主要终点
- NAT Slow Fluctuation Test and Retest to assess change for Test Replicability
研究概览
简要总结
The purpose of this study is to refine a new assessment tool for Attention Deficit/Hyperactivity Disorder (ADHD) and then to test its validity (i.e. ability to discriminate between individuals with ADHD and healthy controls.
详细描述
The purpose of this study is to build upon the success the novel approach and software for analyzing electroencephalography (EEG) data to identify biomarkers of ADHD in adults by further refining the method. Then to test the ability of this new assessment tool to differentiate between adults with ADHD and healthy controls by comparing the classification accuracy of the metrics from the new tool to the classification accuracy of existing behavioral tests for ADHD.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Specific inclusion criteria for ADHD are:
- •meet established Diagnositic and Statistical Manual-5 criteria for ADHD predominately inattentive or combined subtype with clinically significant levels of impairment, diagnosed by structured clinical interview, the Mini International Neuropsychiatric Interview, and corroborating information
- •Clinical Global Impression-Severity (CGI-S) score ≥ 4 for ADHD
- •no lifetime history of DSM-5 bipolar disorder, psychotic disorder, pervasive developmental disorder, obsessive-compulsive disorder, substance abuse, or substance dependence (except nicotine) as assessed with the Mini International Neuropsychiatric Interview (MINI).
- •able in the opinion of the investigator to complete all required study procedures.
排除标准
- •Exclusion criteria for both groups are:
- •History of diagnosis of childhood disorder other than ADHD (e.g. autism, dyslexia)
- •history of any general medical condition likely to require chronic use of medication with identified central nervous system (CNS) effects suspected to alter cognitive performance
- •history of seizure disorder, brain tumor, other major neurological disorder or head injury resulting in loss of consciousness
- •serious oxygen deprivation
- •current psychopathology requiring ongoing treatment with antipsychotic medications, mood stabilizers, benzodiazepines, or anticonvulsants
- •current untreated psychopathology which is rated to be primary in terms of severity (greater than ADHD severity)
- •current treatment with guanfacine.
结局指标
主要结局
NAT Slow Fluctuation Test and Retest to assess change for Test Replicability
时间窗: A single measurement is made for each individual at DAY 1 - the time of the brain wave (EEG) test; and a single measure is made again in each individual at least 30 days later (DAY 2) to identify any differences, to assess replicability of the measure.
The NAT EEG test simultaneously generates 2 EEG values and 1 behavioral value that are used together as an assessment metric for ADHD. This is a one-time measure to assess its magnitude in ADHD vs Control.
次要结局
未报告次要终点
研究者
Gregory Simpson, Ph.D.
Founder and Chief Scientific Officer
Think Now Incorporated