Context-awareness, Physiological Monitoring, and Machine Learning in Migraine and Cluster Headache

NCT ID: NCT04949204

Last Updated: 2022-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2021-07-31

Brief Summary

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This is an observational, longitudinal cohort pilot study measuring physiological signals through wearable sensors combined with machine learning algorithms to detect behaviour, stress and headaches in patients with migraine and cluster headache.

Detailed Description

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Migraine and cluster headache are among the most disabling headache conditions in humans. Both conditions have different phases such as the prodromal/premonitory phase, the aura phase, the headache phase and the postdromal phase. This pilot study examines the potential of wearable sensors combined with machine learning algorithms to investigate the biological changes over time in both conditions. Behaviour such as movement, sleep and activity will be monitored. Stress levels will be estimated through the wearable data combined with input from the patients. Participants will use a wearable device around the wrist and self-developed headache application for 21 days.

Conditions

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Migraine Cluster Headache

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Migraine patients

Wearable wrist sensor + headache application on smartphone

Wearable sensor detection

Intervention Type PROCEDURE

Empatica E4 wearable wrist sensor

Cluster Headache Patients

Wearable wrist sensor + headache application on smartphone

Wearable sensor detection

Intervention Type PROCEDURE

Empatica E4 wearable wrist sensor

Interventions

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Wearable sensor detection

Empatica E4 wearable wrist sensor

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* migraine or cluster headache diagnosis based on ICHD 3 criteria
* at least 2 attacks each month
* onset of headache syndrome before the age of 50
* if multiple headache syndromes coexist: attacks are clearly distinguishable
* participant has smartphone that he/she wants to apply for this research

Exclusion Criteria

* chronic migraine patients
* history of alcohol or illicit drug abuse
* significant medical comorbidity deemed by the investigator to interfere with the study
* use of betablockers
* participating in other academic or commercial trials
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Ghent

OTHER

Sponsor Role collaborator

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital, Ghent: Department of Neurology

Ghent, , Belgium

Site Status

Countries

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Belgium

References

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Vandenbussche N, Van Der Donckt J, De Brouwer M, Steenwinckel B, Stojchevska M, Ongenae F, Van Hoecke S, Paemeleire K. Patients with chronic cluster headache may show reduced activity energy expenditure on ambulatory wrist actigraphy recordings during daytime attacks. Brain Behav. 2024 Jan;14(1):e3360. doi: 10.1002/brb3.3360.

Reference Type DERIVED
PMID: 38376015 (View on PubMed)

De Brouwer M, Vandenbussche N, Steenwinckel B, Stojchevska M, Van Der Donckt J, Degraeve V, Vaneessen J, De Turck F, Volckaert B, Boon P, Paemeleire K, Van Hoecke S, Ongenae F. mBrain: towards the continuous follow-up and headache classification of primary headache disorder patients. BMC Med Inform Decis Mak. 2022 Mar 31;22(1):87. doi: 10.1186/s12911-022-01813-w.

Reference Type DERIVED
PMID: 35361224 (View on PubMed)

Other Identifiers

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BC-07403

Identifier Type: -

Identifier Source: org_study_id

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