mBrain-21 : a Three-month Study on Context-awareness, Physiological Monitoring, and Machine Learning in Migraine and Cluster Headache
MBRAIN-21
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2021
CompletedStudy Start
First participant enrolled
July 19, 2021
CompletedFirst Posted
Study publicly available on registry
July 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 7, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 7, 2023
CompletedFebruary 6, 2024
February 1, 2024
2.1 years
July 5, 2021
February 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Accuracy (F1-scores) machine learning algorithms
Machine learning algorithms for stress detection, sleep detection, activity detection and headache attack detection
After 90 days
Secondary Outcomes (15)
Demographics
At the beginning of the study
Headache phenotype characteristics
At the beginning of the study
Migraine Specific Questionnaire v2.1
After 90 days
MIDAS Migraine Disability Assessment
After 90 days
MOS Short-Form General Health Survey (SF-20)
After 90 days
- +10 more secondary outcomes
Other Outcomes (1)
Feedback from participants
After 90 days
Study Arms (1)
Participants
EXPERIMENTALParticipants wear the Empatica E4 wearable sensor and use the smartphone applications developed by the research team.
Interventions
Empatica E4 wearable sensor and custom-made headache smartphone application
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital, Ghent: Department of Neurology
Ghent, 9000, Belgium
Related Publications (1)
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.
PMID: 39948510DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2021
First Posted
July 30, 2021
Study Start
July 19, 2021
Primary Completion
September 7, 2023
Study Completion
September 7, 2023
Last Updated
February 6, 2024
Record last verified: 2024-02