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

Completed

• Conditions: Migraine; Cluster Headache
• Interventions: Procedure: Wearable sensor detection

• Registration Number: NCT04949204
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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

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 Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2021-06-24
• Study First Submitted QC: 2021-06-24
• Study First Posted: 2021-07-02
• Primary Completion: 2021-07-31
• Study Completion: 2021-07-31
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-02
• Last Update Posted: 2022-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cluster Headache Patients	Wearable sensor detection	Wearable wrist sensor + headache application on smartphone
Migraine patients	Wearable sensor detection	Wearable wrist sensor + headache application on smartphone

Primary Outcome Measures

Name	Time	Method
Galvanic Skin Response changes	21 days	Changes in GSR through the different phases of the headache attacks

Secondary Outcome Measures

Name	Time	Method
Activity ratio	21 days	Activity ratio measurement through accelerometer data
Skin temperature	21 days	Skin temperature measurement through builtin thermometer

Trial Locations

Locations (1)

University Hospital, Ghent: Department of Neurology; 🇧🇪 Ghent, Belgium