mBrain-21 : a Three-month Study on Context-awareness, Physiological Monitoring, and Machine Learning in Migraine and Cluster Headache

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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mBrain-21 : a Three-month Study on Context-awareness, Physiological Monitoring, and Machine Learning in Migraine and Cluster Headache

Conditions
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Migraine, Cluster Headache

Intervention / Treatment
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* Device: Wearable sensor and smartphone application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 50. 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. Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants<br>Participants wear the Empatica E4 wearable sensor and use the smartphone applications developed by the research team. | Device: Wearable sensor and smartphone application<br>* Empatica E4 wearable sensor and custom-made headache smartphone application<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy (F1-scores) machine learning algorithms | Machine learning algorithms for stress detection, sleep detection, activity detection and headache attack detection | After 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographics | Demographic characteristics of participants | At the beginning of the study | 
| Headache phenotype characteristics | Headache phenotype characteristics | At the beginning of the study | 
| Migraine Specific Questionnaire v2.1 | Migraine Specific Questionnaire v2.1 | After 90 days | 
| MIDAS Migraine Disability Assessment | MIDAS Migraine Disability Assessment | After 90 days | 
| MOS Short-Form General Health Survey (SF-20) | MOS Short-Form General Health Survey (SF-20) | After 90 days | 
| Pittsburgh Sleep Quality index | Pittsburgh Sleep Quality index | After 90 days | 
| MUltilevel Assessment of Interoceptive Awareness v2 (MAIAv2) | MUltilevel Assessment of Interoceptive Awareness v2 (MAIAv2) | After 90 days | 
| Perceived Stress Scale (PSS-10) | Perceived Stress Scale (PSS-10) | After 90 days | 
| Connor Davidson Resilience Scale (CD-RISC 25) | Connor Davidson Resilience Scale (CD-RISC 25) | After 90 days | 
| Penn State Worry Questionnaire (PSWQ) | Penn State Worry Questionnaire (PSWQ) | After 90 days | 
| Perseverative Thinking Questionnaire (PTQ) | Perseverative Thinking Questionnaire (PTQ) | After 90 days | 
| Ruminative Response Scale (RRS) | Ruminative Response Scale (RRS) | After 90 days | 
| Basic Needs Scale | Basic Needs Scale | After 90 days | 
| Emotion Regulation Scale | Emotion Regulation Scale | After 90 days | 
| Neuroticism (subscale from BFI) | Neuroticism (subscale from BFI) | After 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cluster Headache, Smartphone application, Machine Learning, Wearable sensor, Migraine