MigraineMBRAIN-21NCT04983186
mBrain-21 : a Three-month Study on Context-awareness, Physiological Monitoring, and Machine Learning in Migraine and Cluster Headache
A study testing Wearable sensor and smartphone application in people with Migraine and Cluster Headache, run by University Hospital, Ghent at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine, Cluster Headache
- What is being tested?
- Wearable sensor and smartphone application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Jul 2021to 7 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Wearable sensor and smartphone application
- Keywords
- Migraine, Cluster Headache, Smartphone application, Machine Learning, Wearable sensor
- Medical subject headings
- Migraine Disorders, Cluster Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable sensor and smartphone applicationDevice
Empatica E4 wearable sensor and custom-made headache smartphone application
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | Participants wear the Empatica E4 wearable sensor and use the smartphone applications developed by the research team. Receives: Device: Wearable sensor and smartphone application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy (F1-scores) machine learning algorithms
Machine learning algorithms for stress detection, sleep detection, activity detection and headache attack detection
Measured: After 90 days
Secondary outcomes (15)
Demographics
Demographic characteristics of participants
Measured: At the beginning of the study
Headache phenotype characteristics
Headache phenotype characteristics
Measured: At the beginning of the study
Migraine Specific Questionnaire v2.1
Migraine Specific Questionnaire v2.1
Measured: After 90 days
MIDAS Migraine Disability Assessment
MIDAS Migraine Disability Assessment
Measured: After 90 days
MOS Short-Form General Health Survey (SF-20)
MOS Short-Form General Health Survey (SF-20)
Measured: After 90 days
Pittsburgh Sleep Quality index
Pittsburgh Sleep Quality index
Measured: After 90 days
MUltilevel Assessment of Interoceptive Awareness v2 (MAIAv2)
MUltilevel Assessment of Interoceptive Awareness v2 (MAIAv2)
Measured: After 90 days
Perceived Stress Scale (PSS-10)
Perceived Stress Scale (PSS-10)
Measured: After 90 days
Connor Davidson Resilience Scale (CD-RISC 25)
Connor Davidson Resilience Scale (CD-RISC 25)
Measured: After 90 days
Penn State Worry Questionnaire (PSWQ)
Penn State Worry Questionnaire (PSWQ)
Measured: After 90 days
Perseverative Thinking Questionnaire (PTQ)
Perseverative Thinking Questionnaire (PTQ)
Measured: After 90 days
Ruminative Response Scale (RRS)
Ruminative Response Scale (RRS)
Measured: After 90 days
Basic Needs Scale
Basic Needs Scale
Measured: After 90 days
Emotion Regulation Scale
Emotion Regulation Scale
Measured: After 90 days
Neuroticism (subscale from BFI)
Neuroticism (subscale from BFI)
Measured: After 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start19 Jul 2021
- Primary completion7 Sep 2023
- Study completion7 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04983186
- Sponsor's protocol ID
- BC-10031
- Acronym
- MBRAIN-21
- Status last verified
- Feb 2024
- First submitted
- 5 Jul 2021
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39948510
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mBrain-21 : a Three-month Study on Context-awareness, Physiological Monitoring, and Machine Learning in Migraine and Cluster Headache
- ClinicalTrials.gov ID
- NCT04983186
- Acronym / sponsor ID
- MBRAIN-21 / BC-10031
- Conditions
- Migraine, Cluster Headache
- Keywords
- Migraine, Cluster Headache, Smartphone application, Machine Learning, Wearable sensor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 7 Sep 2023 (actual)
- Study completion
- 7 Sep 2023 (actual)
- First posted
- 30 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Device: Wearable sensor and smartphone applicationParticipants wear the Empatica E4 wearable sensor and use the smartphone applications developed by the research team. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable sensor and smartphone applicationEmpatica E4 wearable sensor and custom-made headache smartphone application | Device | Participants |
Primary outcome
Accuracy (F1-scores) machine learning algorithms
Time frame: After 90 days
Machine learning algorithms for stress detection, sleep detection, activity detection and headache attack detection
15 secondary outcomes
Demographics
Time frame: At the beginning of the study
Headache phenotype characteristics
Time frame: At the beginning of the study
Migraine Specific Questionnaire v2.1
Time frame: After 90 days
MIDAS Migraine Disability Assessment
Time frame: After 90 days
MOS Short-Form General Health Survey (SF-20)
Time frame: After 90 days
Pittsburgh Sleep Quality index
Time frame: After 90 days
MUltilevel Assessment of Interoceptive Awareness v2 (MAIAv2)
Time frame: After 90 days
Perceived Stress Scale (PSS-10)
Time frame: After 90 days
Connor Davidson Resilience Scale (CD-RISC 25)
Time frame: After 90 days
Penn State Worry Questionnaire (PSWQ)
Time frame: After 90 days
Perseverative Thinking Questionnaire (PTQ)
Time frame: After 90 days
Ruminative Response Scale (RRS)
Time frame: After 90 days
Basic Needs Scale
Time frame: After 90 days
Emotion Regulation Scale
Time frame: After 90 days
Neuroticism (subscale from BFI)
Time frame: After 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Derived from this study: PubMed 39948510Van 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable sensor and smartphone application in people with Migraine and Cluster Headache, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy (F1-scores) machine learning algorithms (time frame: After 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04983186, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.