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临床试验/NCT01962181
NCT01962181Unknown不适用

Identifying Characteristic Signature of Brain Activity of Electroencephalogram Records in Attention Deficit / Hyperactivity Disorder (ADHD) and Ritalin Treatment

Hadassah Medical Organization1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Resting oscillation activity and Event-related-Potentials in Attention Deficit / Hyperactivity Disorder (ADHD) and healthy subjects.

研究概览

简要总结

In this study we try to identify the signature of brain activity in the EEG of attention deficit disorder (ADHD) patients compared to healthy subjects under different doses of Ritalin (methylphenidate) treatment.

详细描述

In this study we try to identify the signature of brain activity in the EEG of attention deficit disorder (ADHD) patients compared to healthy subjects under different doses of Ritalin (methylphenidate) treatment. All subjects will undergo 1-4 EEG sessions. In each session we will use a different dose of Ritalin or placebo. A detailed neuropsychological tests will be done during the EEG recording. A powerful machine-learning techniques will be used in order to find a specific signature of ADHD and Ritalin treatment in the EEG recording.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy subjects, aged 18-50 years.
  • Subjects aged 18-50 years diagnosed with ADHD and treated with Ritalin regularly (at least once a week).

排除标准

  • Patients previously diagnosed as suffering from a brain disease except for ADHD.
  • Patients after traumatic head injury.
  • Patients who are unable to express their consent to participate in the study.

研究组 & 干预措施

Ritalin

Active Comparator

Ritalin treatment at different doses

干预措施: Ritalin (Drug)

Placebo

Placebo Comparator

Two meetings, one of which will be given a placebo and the other will be given a low dose of Ritalin, randomly.

干预措施: Placebo (Drug)

结局指标

主要结局

Resting oscillation activity and Event-related-Potentials in Attention Deficit / Hyperactivity Disorder (ADHD) and healthy subjects.

时间窗: 2 years

The primary outcome measure is the difference in the analysis of EEG recording (for example, resting oscillation activity and Event-related-Potentials) in Attention Deficit / Hyperactivity Disorder (ADHD) vs. healthy subjects.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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