mBrain-21 : a Three-month Study on Context-awareness, Physiological Monitoring, and Machine Learning in Migraine and Cluster Headache
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Accuracy (F1-scores) machine learning algorithms
研究概览
简要总结
This study collects data from migraine and cluster headache patients during a three-month study. Contextual data (e.g. location or smartphone usage) and physiological variables will be used to assist machine learning algorithms in making predictions on activity, stress and sleep in patients with migraine or cluster headache.
详细描述
Migraine and cluster headache are brain disorders with disabling headache attacks and assoicated symptoms. Attacks have multiple phases such as the premonitory phase, aura phase, headache phase and postdromal phase. During those phases, symptoms of homeostatic disturbance or sensory alterations may occur.
The goal of the study is to observe activity, stress and sleep parameters in relation to registered headache attacks.
Participation in the mBrain-21 study will last maximum 90 days. Participants are patients with migraine or cluster heacache recruited within the headache clinic of Ghent University Hospital. Physiological variables such as heart rate, movement and galvanic skin resonse will be measured by the Empatica E4 wrist sensor. Patient-specific experiences during headache attacks and activities of daily life will be registered with a custom-made headache smartphone applications. Contextual data (e.g. smartphone usage or location) can be autonomously collected through smartphone applications.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult participants between the age of 18 en 65 years.
- •Diagnosis of migraine without aura (ICHD-3 diagnosis 1.1) or migraine with aura (ICHD-3 diagnosis 1.2) or chronic migraine (ICHD-3 diagnosis 1.3)
- •Headache crystal clear days on minimum 5 days per month on average.
- •Onset of headache syndrome before the age of
- •Attacks of migraine or cluster headache are clearly distinguishable from other types of headache disorders if present.
- •Participant complies with protocol to use smartphone applications on his or her own Android-based smartphone (minimum version 8.0) and to provide access to his or her smartphone dataplan.
排除标准
- 未提供
研究组 & 干预措施
Participants
Participants wear the Empatica E4 wearable sensor and use the smartphone applications developed by the research team.
干预措施: Wearable sensor and smartphone application (Device)
结局指标
主要结局
Accuracy (F1-scores) machine learning algorithms
时间窗: After 90 days
Machine learning algorithms for stress detection, sleep detection, activity detection and headache attack detection
次要结局
- Basic Needs Scale(After 90 days)
- Emotion Regulation Scale(After 90 days)
- MIDAS Migraine Disability Assessment(After 90 days)
- MOS Short-Form General Health Survey (SF-20)(After 90 days)
- Perseverative Thinking Questionnaire (PTQ)(After 90 days)
- Connor Davidson Resilience Scale (CD-RISC 25)(After 90 days)
- Headache phenotype characteristics(At the beginning of the study)
- Perceived Stress Scale (PSS-10)(After 90 days)
- Ruminative Response Scale (RRS)(After 90 days)
- Demographics(At the beginning of the study)
- Migraine Specific Questionnaire v2.1(After 90 days)
- MUltilevel Assessment of Interoceptive Awareness v2 (MAIAv2)(After 90 days)
- Penn State Worry Questionnaire (PSWQ)(After 90 days)
- Neuroticism (subscale from BFI)(After 90 days)
- Pittsburgh Sleep Quality index(After 90 days)