Cluster Headache, Migraine
Conditions
Keywords
Migraine, Cluster Headache, Smartphone application, Machine Learning, Wearable sensor
Brief summary
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
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.
Interventions
DEVICEWearable sensor and smartphone application
Empatica E4 wearable sensor and custom-made headache smartphone application
Sponsors
University Hospital, Ghent
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy (F1-scores) machine learning algorithms | After 90 days | Machine learning algorithms for stress detection, sleep detection, activity detection and headache attack detection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perseverative Thinking Questionnaire (PTQ) | After 90 days | Perseverative Thinking Questionnaire (PTQ) |
| Ruminative Response Scale (RRS) | After 90 days | Ruminative Response Scale (RRS) |
| Basic Needs Scale | After 90 days | Basic Needs Scale |
| Emotion Regulation Scale | After 90 days | Emotion Regulation Scale |
| Neuroticism (subscale from BFI) | After 90 days | Neuroticism (subscale from BFI) |
| MOS Short-Form General Health Survey (SF-20) | After 90 days | MOS Short-Form General Health Survey (SF-20) |
| MIDAS Migraine Disability Assessment | After 90 days | MIDAS Migraine Disability Assessment |
| MUltilevel Assessment of Interoceptive Awareness v2 (MAIAv2) | After 90 days | MUltilevel Assessment of Interoceptive Awareness v2 (MAIAv2) |
| Perceived Stress Scale (PSS-10) | After 90 days | Perceived Stress Scale (PSS-10) |
| Connor Davidson Resilience Scale (CD-RISC 25) | After 90 days | Connor Davidson Resilience Scale (CD-RISC 25) |
| Penn State Worry Questionnaire (PSWQ) | After 90 days | Penn State Worry Questionnaire (PSWQ) |
| Demographics | At the beginning of the study | Demographic characteristics of participants |
| Headache phenotype characteristics | At the beginning of the study | Headache phenotype characteristics |
| Migraine Specific Questionnaire v2.1 | After 90 days | Migraine Specific Questionnaire v2.1 |
| Pittsburgh Sleep Quality index | After 90 days | Pittsburgh Sleep Quality index |
Other
| Measure | Time frame | Description |
|---|---|---|
| Feedback from participants | After 90 days | Feedback from participants on compliance, adherence, usability and user experience of study infrastructure |
Countries
Belgium
Outcome results
None listed