Skip to main content
OpenTrials
Completed

NCT Number: NCT04983186

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Ghent: Department of Neurology

Ghent, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Wearable sensor and smartphone application

Device

Empatica E4 wearable sensor and custom-made headache smartphone application

Primary outcomes

  1. 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

Secondary outcomes

  1. Demographics

    Time frame: At the beginning of the study

    Demographic characteristics of participants

  2. Headache phenotype characteristics

    Time frame: At the beginning of the study

    Headache phenotype characteristics

  3. Migraine Specific Questionnaire v2.1

    Time frame: After 90 days

    Migraine Specific Questionnaire v2.1

  4. MIDAS Migraine Disability Assessment

    Time frame: After 90 days

    MIDAS Migraine Disability Assessment

  5. MOS Short-Form General Health Survey (SF-20)

    Time frame: After 90 days

    MOS Short-Form General Health Survey (SF-20)

  6. Pittsburgh Sleep Quality index

    Time frame: After 90 days

    Pittsburgh Sleep Quality index

  7. MUltilevel Assessment of Interoceptive Awareness v2 (MAIAv2)

    Time frame: After 90 days

    MUltilevel Assessment of Interoceptive Awareness v2 (MAIAv2)

  8. Perceived Stress Scale (PSS-10)

    Time frame: After 90 days

    Perceived Stress Scale (PSS-10)

  9. Connor Davidson Resilience Scale (CD-RISC 25)

    Time frame: After 90 days

    Connor Davidson Resilience Scale (CD-RISC 25)

  10. Penn State Worry Questionnaire (PSWQ)

    Time frame: After 90 days

    Penn State Worry Questionnaire (PSWQ)

  11. Perseverative Thinking Questionnaire (PTQ)

    Time frame: After 90 days

    Perseverative Thinking Questionnaire (PTQ)

  12. Ruminative Response Scale (RRS)

    Time frame: After 90 days

    Ruminative Response Scale (RRS)

  13. Basic Needs Scale

    Time frame: After 90 days

    Basic Needs Scale

  14. Emotion Regulation Scale

    Time frame: After 90 days

    Emotion Regulation Scale

  15. Neuroticism (subscale from BFI)

    Time frame: After 90 days

    Neuroticism (subscale from BFI)

Other outcomes

  1. Feedback from participants

    Time frame: After 90 days

    Feedback from participants on compliance, adherence, usability and user experience of study infrastructure

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Acronym: MBRAIN-21

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 30, 2021
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.