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

Migraine Clinical Trial

— MBRAIN-21  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04983186
• Other study ID #: BC-10031
• Status: Completed
• Phase: N/A
• Start date: July 19, 2021
• Est. completion date: September 7, 2023

Study information

• Verified date: February 2024
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 7, 2023
• Est. primary completion date: September 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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: -

Related Conditions & MeSH terms

• Cluster Headache
• Headache
• Migraine
• Migraine Disorders

Intervention

Device:
• Wearable sensor and smartphone application
Empatica E4 wearable sensor and custom-made headache smartphone application

Locations

Country	Name	City	State
Belgium	University Hospital, Ghent: Department of Neurology	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feedback from participants	Feedback from participants on compliance, adherence, usability and user experience of study infrastructure	After 90 days
Primary	Accuracy (F1-scores) machine learning algorithms	Machine learning algorithms for stress detection, sleep detection, activity detection and headache attack detection	After 90 days
Secondary	Demographics	Demographic characteristics of participants	At the beginning of the study
Secondary	Headache phenotype characteristics	Headache phenotype characteristics	At the beginning of the study
Secondary	Migraine Specific Questionnaire v2.1	Migraine Specific Questionnaire v2.1	After 90 days
Secondary	MIDAS Migraine Disability Assessment	MIDAS Migraine Disability Assessment	After 90 days
Secondary	MOS Short-Form General Health Survey (SF-20)	MOS Short-Form General Health Survey (SF-20)	After 90 days
Secondary	Pittsburgh Sleep Quality index	Pittsburgh Sleep Quality index	After 90 days
Secondary	MUltilevel Assessment of Interoceptive Awareness v2 (MAIAv2)	MUltilevel Assessment of Interoceptive Awareness v2 (MAIAv2)	After 90 days
Secondary	Perceived Stress Scale (PSS-10)	Perceived Stress Scale (PSS-10)	After 90 days
Secondary	Connor Davidson Resilience Scale (CD-RISC 25)	Connor Davidson Resilience Scale (CD-RISC 25)	After 90 days
Secondary	Penn State Worry Questionnaire (PSWQ)	Penn State Worry Questionnaire (PSWQ)	After 90 days
Secondary	Perseverative Thinking Questionnaire (PTQ)	Perseverative Thinking Questionnaire (PTQ)	After 90 days
Secondary	Ruminative Response Scale (RRS)	Ruminative Response Scale (RRS)	After 90 days
Secondary	Basic Needs Scale	Basic Needs Scale	After 90 days
Secondary	Emotion Regulation Scale	Emotion Regulation Scale	After 90 days
Secondary	Neuroticism (subscale from BFI)	Neuroticism (subscale from BFI)	After 90 days