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

NCT ID: NCT04983186

Last Updated: 2024-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-19
• Study Completion Date: 2023-09-07

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.

Conditions

Migraine; Cluster Headache

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Participants

Participants wear the Empatica E4 wearable sensor and use the smartphone applications developed by the research team.

Group Type: EXPERIMENTAL

Wearable sensor and smartphone application

Intervention Type: DEVICE

Empatica E4 wearable sensor and custom-made headache smartphone application

Interventions

Wearable sensor and smartphone application

Empatica E4 wearable sensor and custom-made headache smartphone application

Intervention Type: DEVICE

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

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital, Ghent: Department of Neurology

Ghent, , Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 39948510 (View on PubMed)

Other Identifiers

BC-10031

Identifier Type: -

Identifier Source: org_study_id