Evaluation of Migraine Management Mobile App Combined With Electrophysiological Measurements for Identification of Migraine Attack Risk and Beneficial Preventive Actions.
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Evaluation of correlation of attention-related electrophysiological changes and patients' migraine dynamics based at-home EEG measurements via mobile phone app.
研究概览
简要总结
Evaluation of migraine management mobile app combined with electrophysiological measurements for identification of migraine attack risk and beneficial preventive actions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 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
- 否
入选标准
- •Diagnosed with migraine by a neurologist.
- •Male or Female, aged 18 -50 years.
- •Having 3-10 migraine attacks per month.
- •Able and willing to comply with all study requirements.
- •Having Android based smartphone
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 eardrum impairment.
- •Having migraine attacks occurring only during the menstruation.
研究组 & 干预措施
Arm I
15-45 participants will be monitored for 4-6 weeks, using the App in a Closed version followed by 4-6 weeks, using the App in an Open version (A version of the app the generates recommendations of ADL interventions) , with feedback based on diary information and BEI; followed by 4-6 weeks using the App in an Open version, with feedback based on diary information only.
干预措施: BEI (Device)
Arm II
15-45 participants will be monitored for 4-6 weeks, using the App in a Closed version followed by 4-6 weeks, using the App in an Open version with feedback based on diary information only followed by 4-6 weeks; followed by 4-6 weeks using the App in an Open version, with feedback based on diary information and BEI. Note the difference between Arm I and Arm II is the order of use of BEI in addition to the diary feedback.
干预措施: BEI (Device)
结局指标
主要结局
Evaluation of correlation of attention-related electrophysiological changes and patients' migraine dynamics based at-home EEG measurements via mobile phone app.
时间窗: 12 months
significant difference between interictal days and treictal days
次要结局
未报告次要终点