University Hospital, Ghent: Department of Neurology
Ghent, 9000, Belgium
NCT Number: NCT04983186
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Ghent, 9000, Belgium
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-
Empatica E4 wearable sensor and custom-made headache smartphone application
Time frame: After 90 days
Machine learning algorithms for stress detection, sleep detection, activity detection and headache attack detection
Time frame: At the beginning of the study
Demographic characteristics of participants
Time frame: At the beginning of the study
Headache phenotype characteristics
Time frame: After 90 days
Migraine Specific Questionnaire v2.1
Time frame: After 90 days
MIDAS Migraine Disability Assessment
Time frame: After 90 days
MOS Short-Form General Health Survey (SF-20)
Time frame: After 90 days
Pittsburgh Sleep Quality index
Time frame: After 90 days
MUltilevel Assessment of Interoceptive Awareness v2 (MAIAv2)
Time frame: After 90 days
Perceived Stress Scale (PSS-10)
Time frame: After 90 days
Connor Davidson Resilience Scale (CD-RISC 25)
Time frame: After 90 days
Penn State Worry Questionnaire (PSWQ)
Time frame: After 90 days
Perseverative Thinking Questionnaire (PTQ)
Time frame: After 90 days
Ruminative Response Scale (RRS)
Time frame: After 90 days
Basic Needs Scale
Time frame: After 90 days
Emotion Regulation Scale
Time frame: After 90 days
Neuroticism (subscale from BFI)
Time frame: After 90 days
Feedback from participants on compliance, adherence, usability and user experience of study infrastructure
University Hospital, Ghent
Other
Acronym: MBRAIN-21
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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