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

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.

Study Overview

• Status: Completed
• Conditions: Migraine; Cluster Headache
• Intervention / Treatment: Device: Wearable sensor and smartphone application

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicolas Vandenbussche, M.D.; Phone Number: 093324529; Email: nicolas.vandenbussche@ugent.be

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • University Hospital, Ghent: Department of Neurology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants; Participants wear the Empatica E4 wearable sensor and use the smartphone applications developed by the research team.	Device: Wearable sensor and smartphone application; Empatica E4 wearable sensor and custom-made headache smartphone application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy (F1-scores) machine learning algorithms	Machine learning algorithms for stress detection, sleep detection, activity detection and headache attack detection	After 90 days

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feedback from participants	Feedback from participants on compliance, adherence, usability and user experience of study infrastructure	After 90 days

Collaborators and Investigators

• Sponsor: University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2021
• Primary Completion (Actual): September 7, 2023
• Study Completion (Actual): September 7, 2023

Study Registration Dates

• First Submitted: July 5, 2021
• First Submitted That Met QC Criteria: July 19, 2021
• First Posted (Actual): July 30, 2021

Study Record Updates

• Last Update Posted (Actual): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Migraine; Wearable sensor; Smartphone application; Cluster Headache; Machine Learning
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Trigeminal Autonomic Cephalalgias; Migraine Disorders; Headache; Cluster Headache
• Other Study ID Numbers: BC-10031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No