Clinical trial NCT04983186: mBrain-21 : a Three-month Study on Context-awareness, Physiological Monitoring, and Machine Learning in Migraine and Cluster Headache
Official title: mBrain-21 : a Three-month Study on Context-awareness, Physiological Monitoring, and Machine Learning in Migraine and Cluster Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Cluster Headache
Keywords: Migraine
Cluster Headache
Smartphone application
Machine Learning
Wearable sensor
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2021-07-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Accuracy (F1-scores) machine learning algorithms
timeFrame: After 90 days
Secondary outcomes:
measure: Demographics
timeFrame: At the beginning of the study
measure: Headache phenotype characteristics
timeFrame: At the beginning of the study
measure: Migraine Specific Questionnaire v2.1
timeFrame: After 90 days
measure: MIDAS Migraine Disability Assessment
timeFrame: After 90 days
measure: MOS Short-Form General Health Survey (SF-20)
timeFrame: After 90 days
measure: Pittsburgh Sleep Quality index
timeFrame: After 90 days
measure: MUltilevel Assessment of Interoceptive Awareness v2 (MAIAv2)
timeFrame: After 90 days
measure: Perceived Stress Scale (PSS-10)
timeFrame: After 90 days
measure: Connor Davidson Resilience Scale (CD-RISC 25)
timeFrame: After 90 days
measure: Penn State Worry Questionnaire (PSWQ)
timeFrame: After 90 days
measure: Perseverative Thinking Questionnaire (PTQ)
timeFrame: After 90 days
measure: Ruminative Response Scale (RRS)
timeFrame: After 90 days
measure: Basic Needs Scale
timeFrame: After 90 days
measure: Emotion Regulation Scale
timeFrame: After 90 days
measure: Neuroticism (subscale from BFI)
timeFrame: After 90 days
Other outcomes:
measure: Feedback from participants
timeFrame: After 90 days
Locations:
city: Ghent
country: Belgium
facility: University Hospital, Ghent: Department of Neurology
Study officials:
References: