mBrain-21 : a Three-month Study on Context-awareness, Physiological Monitoring, and Machine Learning in Migraine and Cluster Headache

Not Applicable

Completed

• Conditions: Migraine; Cluster Headache
• Interventions: Device: Wearable sensor and smartphone application

• Registration Number: NCT04983186
• Lead Sponsor: University Hospital, Ghent

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.

Study Timeline

• Study First Submitted: 2021-07-05
• Study Start: 2021-07-19
• Study First Submitted QC: 2021-07-19
• Study First Posted: 2021-07-30
• Primary Completion: 2023-09-07
• Study Completion: 2023-09-07
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants	Wearable sensor and smartphone application	Participants wear the Empatica E4 wearable sensor and use the smartphone applications developed by the research team.

Primary Outcome Measures

Name	Time	Method
Accuracy (F1-scores) machine learning algorithms	After 90 days	Machine learning algorithms for stress detection, sleep detection, activity detection and headache attack detection

Secondary Outcome Measures

Name	Time	Method
Perceived Stress Scale (PSS-10)	After 90 days	Perceived Stress Scale (PSS-10)
MOS Short-Form General Health Survey (SF-20)	After 90 days	MOS Short-Form General Health Survey (SF-20)
Perseverative Thinking Questionnaire (PTQ)	After 90 days	Perseverative Thinking Questionnaire (PTQ)
MIDAS Migraine Disability Assessment	After 90 days	MIDAS Migraine Disability Assessment
Connor Davidson Resilience Scale (CD-RISC 25)	After 90 days	Connor Davidson Resilience Scale (CD-RISC 25)
Basic Needs Scale	After 90 days	Basic Needs Scale
Emotion Regulation Scale	After 90 days	Emotion Regulation Scale
Headache phenotype characteristics	At the beginning of the study	Headache phenotype characteristics
Ruminative Response Scale (RRS)	After 90 days	Ruminative Response Scale (RRS)
Demographics	At the beginning of the study	Demographic characteristics of participants
Migraine Specific Questionnaire v2.1	After 90 days	Migraine Specific Questionnaire v2.1
MUltilevel Assessment of Interoceptive Awareness v2 (MAIAv2)	After 90 days	MUltilevel Assessment of Interoceptive Awareness v2 (MAIAv2)
Penn State Worry Questionnaire (PSWQ)	After 90 days	Penn State Worry Questionnaire (PSWQ)
Neuroticism (subscale from BFI)	After 90 days	Neuroticism (subscale from BFI)
Pittsburgh Sleep Quality index	After 90 days	Pittsburgh Sleep Quality index

Trial Locations

Locations (1)

University Hospital, Ghent: Department of Neurology; 🇧🇪 Ghent, Belgium