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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants | Experimental | Participants wear the Empatica E4 wearable sensor and use the smartphone applications developed by the research team. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wearable sensor and smartphone application | Device | Empatica E4 wearable sensor and custom-made headache smartphone application |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Demographics | Demographic characteristics of participants | At the beginning of the study |
| Headache phenotype characteristics | Headache phenotype characteristics |
| Measure | Description | Time Frame |
|---|---|---|
| Feedback from participants | Feedback from participants on compliance, adherence, usability and user experience of study infrastructure | After 90 days |
Inclusion Criteria:
Exclusion Criteria:
-
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Ghent: Department of Neurology | Ghent | 9000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39948510 | Derived | Van Der Donckt J, Vandenbussche N, De Brouwer M, Steenwinckel B, Stojchevska M, Ongenae F, Paemeleire K, Van Hoecke S. Analysis of free-living daytime movement in patients with migraine with access to acute treatment. J Headache Pain. 2025 Feb 13;26(1):33. doi: 10.1186/s10194-025-01971-y. |
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| 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 |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D003027 | Cluster Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D051303 | Trigeminal Autonomic Cephalalgias |
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