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临床试验/NCT02583581
NCT02583581Unknown不适用

A Feasibility Study for Examination the Use of Brain Prefrontal Activity Monitoring, for Early Detection of Migraine Attack

Brainmarc Ltd.2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
Measurements of brain electrical signal in Micro volt.

研究概览

简要总结

This study evaluates the use of brain activity monitoring for prediction of migraine attacks in an expected time scale of 12-48 hours prior to the migraine attack.

详细描述

The study will be conducted in one are. Participants diagnosed with migraine, will be evaluated for their EEG characteristics as well as daily migraine related clinical and general status. Participants' monitoring will be conducted for 20 times for a duration of one month.

研究设计

研究类型
Interventional
分配方式
Na
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 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with migraine by a neurologist.
  • Male or Female, aged 18 -50 years.
  • Able and willing to comply with all study requirements.
  • Having 3-10 migraine attacks per month.

排除标准

  • Diagnosed with chronic pain, neurological or psychiatric disorders.
  • Current or past use of anti-depressants.
  • A user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence.
  • History of seizures
  • Head injury with consciousness loss in the last three months.
  • Diagnosed as ADHD and/or use of Ritalin.
  • Hearing disorder and/or known ear drum impairment.
  • Having migraine attacks occurring only during the menstruation.

结局指标

主要结局

Measurements of brain electrical signal in Micro volt.

时间窗: 1 months

Measurements of brain electrical signal in Micro volt will be quantified by an algorithm and correlated to reported migraine cycle (as reported by migraine patients in questionnaires).

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 (2)

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