NCT04983186

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Migraine
• Cluster Headache

Interventions

Type	Name	Description
DEVICE	Wearable sensor and smartphone application	Empatica E4 wearable sensor and custom-made headache smartphone application

Timeline

• Start date: 2021-07-19
• Primary completion: 2023-09-07
• Completion: 2023-09-07
• First posted: 2021-07-30
• Last updated: 2024-02-06

Locations

1 site across 1 country: Belgium