Brain Activity Flow Patterns Analysis Using Evoked Response Potentials in Youth With ADHD, Bipolar Disorder, or Autism Spectrum Disorders: A Preliminary Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Agreement between clinical diagnoses and the results of brain activity flow pattern analysis (BAFPA).
研究概览
简要总结
The study aims to evaluate whether or not an EEG (a type of brain scan) is useful in diagnosing youth with either ADHD, BPD, ASD. Youth with ADHD, BPD, ASD, and healthy controls (without ADHD, BPD, and ASD) will undergo an EEG, and the results will be analyzed using brain activity flow pattern analysis (BAFPA). Twenty subjects with each disorder and twenty without any of the disorders under study (controls) will be evaluated. All subjects will be comprehensively assessed with structured diagnostic interviews and neuropsychological testing. All EEG analyses will be conducted under blind conditions. Conditional probability and receiver operating characteristic (ROC) analyses will examine the diagnostic utility of the EEG scan, using the clinical diagnosis of ASD as the gold standard.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female participants between 6 and 17 years of age.
- •Right handedness.
- •Fulfills DSM-IV-TR diagnostic criteria for ADHD, bipolar disorder (BPD I, II, or NOS), or ASD (autistic disorder, Asperger's disorder, or PDD-NOS) as established by clinical diagnostic interview and supported by K-SADS-E module for respective diagnoses.
- •Subjects and their legal representative must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.
- •Subjects and their legal representative must be considered reliable.
- •Each subject and his/her authorized legal representative must understand the nature of the study. The subject's authorized legal representative must sign an informed consent document and the subject must sign an informed assent document.
排除标准
- •Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
- •I.Q. < 85
- •History of active seizure disorder (as suggested by EEG suggestive of seizure activity and/or history of seizure in last 1 month)
- •Pregnant or nursing females.
- •Subjects with a medical condition that will either jeopardize subject safety or affect the scientific merit of the study, including:
- •Organic brain disorders
- •Uncorrected hypothyroidism or hyperthyroidism
- •Renal or hepatic impairment.
- •Clinically unstable psychiatric conditions or judged to be at serious suicidal risk
- •Current diagnosis of schizophrenia
- •History of substance use (except nicotine or caffeine) within past 3 months or urine drug screen positive for substances of abuse
- •Significant sensory deficits such as deafness or blindness.
结局指标
主要结局
Agreement between clinical diagnoses and the results of brain activity flow pattern analysis (BAFPA).
时间窗: Baseline
Subjects will undergo clinical diagnostic interviews and a comprehensive neuropsychological assessment, and then complete 1 EEG scan of approximately 1 hour. The results of the BAFPA will be compared to the results of the clinical diagnostic interviews.
次要结局
未报告次要终点
研究者
Gagan Joshi
Scientific Director, Pervasive Developmental Disorders Program, Clinical and Research Programs in Pediatric Psychopharmacology
Massachusetts General Hospital