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

Migraine Clinical Trial

— COPIMAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04949204
• Other study ID #: BC-07403
• Status: Completed
• Start date: July 1, 2020
• Est. completion date: July 31, 2021

Study information

• Verified date: December 2022
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cluster Headache
• Headache
• Migraine
• Migraine Disorders

Intervention

Procedure:
• Wearable sensor detection
Empatica E4 wearable wrist sensor

Locations

Country	Name	City	State
Belgium	University Hospital, Ghent: Department of Neurology	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Prevalence of premonitory symptoms		21 days
Other	Prevalence of cranial autonomic symptoms		21 days
Other	Prevalence of postdromal symptoms		21 days
Other	MSQv2.1 questionnaire	In migraine patients	21 days
Other	MIDAS questionnaire	In migraine patients	21 days
Other	SF20	In migraine and cluster headache patients	21 days
Primary	Galvanic Skin Response changes	Changes in GSR through the different phases of the headache attacks	21 days
Secondary	Activity ratio	Activity ratio measurement through accelerometer data	21 days
Secondary	Skin temperature	Skin temperature measurement through builtin thermometer	21 days