Back to resultsmBrain-21 : a Three-month Study on Context-awareness, Physiological Monitoring, and Machine Learning in Migraine and Cluster Headache (MBRAIN-21)
Primary Purpose
Migraine, Cluster Headache
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Wearable sensor and smartphone application
Sponsored by
About this trial
This is an interventional diagnostic trial for Migraine focused on measuring Migraine, Cluster Headache, Smartphone application, Machine Learning, Wearable sensor
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:
-
Sites / Locations
- University Hospital, Ghent: Department of NeurologyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Participants
Arm Description
Participants wear the Empatica E4 wearable sensor and use the smartphone applications developed by the research team.
Outcomes
Primary Outcome Measures
Accuracy (F1-scores) machine learning algorithms
Machine learning algorithms for stress detection, sleep detection, activity detection and headache attack detection
Secondary Outcome Measures
Demographics
Demographic characteristics of participants
Headache phenotype characteristics
Headache phenotype characteristics
Migraine Specific Questionnaire v2.1
Migraine Specific Questionnaire v2.1
MIDAS Migraine Disability Assessment
MIDAS Migraine Disability Assessment
MOS Short-Form General Health Survey (SF-20)
MOS Short-Form General Health Survey (SF-20)
Pittsburgh Sleep Quality index
Pittsburgh Sleep Quality index
MUltilevel Assessment of Interoceptive Awareness v2 (MAIAv2)
MUltilevel Assessment of Interoceptive Awareness v2 (MAIAv2)
Perceived Stress Scale (PSS-10)
Perceived Stress Scale (PSS-10)
Connor Davidson Resilience Scale (CD-RISC 25)
Connor Davidson Resilience Scale (CD-RISC 25)
Penn State Worry Questionnaire (PSWQ)
Penn State Worry Questionnaire (PSWQ)
Perseverative Thinking Questionnaire (PTQ)
Perseverative Thinking Questionnaire (PTQ)
Ruminative Response Scale (RRS)
Ruminative Response Scale (RRS)
Basic Needs Scale
Basic Needs Scale
Emotion Regulation Scale
Emotion Regulation Scale
Neuroticism (subscale from BFI)
Neuroticism (subscale from BFI)
Full Information
NCT ID
NCT04983186
First Posted
July 5, 2021
Last Updated
December 5, 2022
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT04983186
Brief Title
mBrain-21 : a Three-month Study on Context-awareness, Physiological Monitoring, and Machine Learning in Migraine and Cluster Headache
Acronym
MBRAIN-21
Official Title
mBrain-21 : a Three-month Study on Context-awareness, Physiological Monitoring, and Machine Learning in Migraine and Cluster Headache
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 19, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Cluster Headache
Keywords
Migraine, Cluster Headache, Smartphone application, Machine Learning, Wearable sensor
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Participants
Arm Type
Experimental
Arm Description
Participants wear the Empatica E4 wearable sensor and use the smartphone applications developed by the research team.
Intervention Type
Device
Intervention Name(s)
Wearable sensor and smartphone application
Intervention Description
Empatica E4 wearable sensor and custom-made headache smartphone application
Primary Outcome Measure Information:
Title
Accuracy (F1-scores) machine learning algorithms
Description
Machine learning algorithms for stress detection, sleep detection, activity detection and headache attack detection
Time Frame
After 90 days
Secondary Outcome Measure Information:
Title
Demographics
Description
Demographic characteristics of participants
Time Frame
At the beginning of the study
Title
Headache phenotype characteristics
Description
Headache phenotype characteristics
Time Frame
At the beginning of the study
Title
Migraine Specific Questionnaire v2.1
Description
Migraine Specific Questionnaire v2.1
Time Frame
After 90 days
Title
MIDAS Migraine Disability Assessment
Description
MIDAS Migraine Disability Assessment
Time Frame
After 90 days
Title
MOS Short-Form General Health Survey (SF-20)
Description
MOS Short-Form General Health Survey (SF-20)
Time Frame
After 90 days
Title
Pittsburgh Sleep Quality index
Description
Pittsburgh Sleep Quality index
Time Frame
After 90 days
Title
MUltilevel Assessment of Interoceptive Awareness v2 (MAIAv2)
Description
MUltilevel Assessment of Interoceptive Awareness v2 (MAIAv2)
Time Frame
After 90 days
Title
Perceived Stress Scale (PSS-10)
Description
Perceived Stress Scale (PSS-10)
Time Frame
After 90 days
Title
Connor Davidson Resilience Scale (CD-RISC 25)
Description
Connor Davidson Resilience Scale (CD-RISC 25)
Time Frame
After 90 days
Title
Penn State Worry Questionnaire (PSWQ)
Description
Penn State Worry Questionnaire (PSWQ)
Time Frame
After 90 days
Title
Perseverative Thinking Questionnaire (PTQ)
Description
Perseverative Thinking Questionnaire (PTQ)
Time Frame
After 90 days
Title
Ruminative Response Scale (RRS)
Description
Ruminative Response Scale (RRS)
Time Frame
After 90 days
Title
Basic Needs Scale
Description
Basic Needs Scale
Time Frame
After 90 days
Title
Emotion Regulation Scale
Description
Emotion Regulation Scale
Time Frame
After 90 days
Title
Neuroticism (subscale from BFI)
Description
Neuroticism (subscale from BFI)
Time Frame
After 90 days
Other Pre-specified Outcome Measures:
Title
Feedback from participants
Description
Feedback from participants on compliance, adherence, usability and user experience of study infrastructure
Time Frame
After 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas Vandenbussche, M.D.
Phone
093324529
Email
nicolas.vandenbussche@ugent.be
Facility Information:
Facility Name
University Hospital, Ghent: Department of Neurology
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Vandenbussche, MD
Phone
09 332 45 29
Email
nicolas.vandenbussche@ugent.be
First Name & Middle Initial & Last Name & Degree
Koen Paemeleire, MD PhD
Phone
09 332 45 29
Email
koen.paemeleire@uzgent.be
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
mBrain-21 : a Three-month Study on Context-awareness, Physiological Monitoring, and Machine Learning in Migraine and Cluster Headache
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