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

Contextuele Analyse, Fysiologische Metingen en Machinaal Leren Voor Migraine en Clusterhoofdpijn (COPIMAC Studie)

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.

Study Overview

• Status: Completed
• Conditions: Migraine; Cluster Headache
• Intervention / Treatment: Procedure: Wearable sensor detection

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

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
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Migraine or cluster headache patients

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Migraine patients; Wearable wrist sensor + headache application on smartphone	Procedure: Wearable sensor detection; Empatica E4 wearable wrist sensor
Cluster Headache Patients; Wearable wrist sensor + headache application on smartphone	Procedure: Wearable sensor detection; Empatica E4 wearable wrist sensor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Galvanic Skin Response changes	Changes in GSR through the different phases of the headache attacks	21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activity ratio	Activity ratio measurement through accelerometer data	21 days
Skin temperature	Skin temperature measurement through builtin thermometer	21 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of premonitory symptoms		21 days
Prevalence of cranial autonomic symptoms		21 days
Prevalence of postdromal symptoms		21 days
MSQv2.1 questionnaire	In migraine patients	21 days
MIDAS questionnaire	In migraine patients	21 days
SF20	In migraine and cluster headache patients	21 days

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: University Ghent

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): July 31, 2021
• Study Completion (Actual): July 31, 2021

Study Registration Dates

• First Submitted: June 24, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): July 2, 2021

Study Record Updates

• Last Update Posted (Actual): December 5, 2022
• Last Update Submitted That Met QC Criteria: December 2, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• 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-07403

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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