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临床试验/NCT02625805
NCT02625805已完成不适用

Evaluation of the Ability for Monitoring Dynamics in ADD/ADHD With an Easy to Use EEG

Brainmarc Ltd.1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年4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
状态
已完成
入组人数
30
试验地点
1
主要终点
Measurements of brain electrical signal in Micro volt.

研究概览

简要总结

This study evaluates the ability to support diagnosis and monitor of the dynamics in ADD/ADHD subjects with an easy to use EEG Device.

详细描述

The study will be conducted in two arms (arm I and arm II). In arm I, participants diagnosed with ADD/ADHD. In arm II, healthy participants.

The status of the participants will be evaluated with questionnaires computerized test and EEG characteristics will be collected for all study participants. .

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Male or Female, aged 18 -45 years.
  • Able and willing to comply with all study requirements.
  • Diagnosed with ADD/ADHD based on clinical evaluation based on the questionnaires:
  • Adult ADHD Self-Report Scale (ASRS)
  • Wender-Utah Rating Scale
  • Positive And Negative Affect Schedule (PANAS)

排除标准

  • Diagnosed with Psychotic or bipolar disorder.
  • Diagnosed with a substantial Neurological disorder or general medical condition with an effect on EEG patterns such as Epilepsy or stroke
  • A user of recreational or illicit drugs or has had a recent history (six months) of drug or alcohol abuse or dependence.
  • Cognitive impairment.
  • Hearing disorder and/or known ear drum impairment.

研究组 & 干预措施

Participants diagnosed with ADD/ADHD

Experimental

EEG monitoring (MindWave by NeuroSky and EPOC by Emotiv) and Methylphenidate administration

干预措施: EEG monitoring (MindWave by NeuroSky) (Device)

Participants diagnosed with ADD/ADHD

Experimental

EEG monitoring (MindWave by NeuroSky and EPOC by Emotiv) and Methylphenidate administration

干预措施: EEG monitoring (EPOC by Emotiv) (Device)

Participants diagnosed with ADD/ADHD

Experimental

EEG monitoring (MindWave by NeuroSky and EPOC by Emotiv) and Methylphenidate administration

干预措施: Methylphenidate (Drug)

Healthy participants

Experimental

EEG monitoring (MindWave by NeuroSky and EPOC by Emotiv) and Methylphenidate administration

干预措施: EEG monitoring (MindWave by NeuroSky) (Device)

Healthy participants

Experimental

EEG monitoring (MindWave by NeuroSky and EPOC by Emotiv) and Methylphenidate administration

干预措施: EEG monitoring (EPOC by Emotiv) (Device)

Healthy participants

Experimental

EEG monitoring (MindWave by NeuroSky and EPOC by Emotiv) and Methylphenidate administration

干预措施: Methylphenidate (Drug)

结局指标

主要结局

Measurements of brain electrical signal in Micro volt.

时间窗: 2 weeks

Measurements of brain electrical signal in Micro volt will be quantified by an algorithm and correlated to ADHD state as evaluated by participants questionnaires, and computerized test.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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