Clinical trial NCT04949204: Context-awareness, Physiological Monitoring, and Machine Learning in Migraine and Cluster Headache
Official title: Contextuele Analyse, Fysiologische Metingen en Machinaal Leren Voor Migraine en Clusterhoofdpijn (COPIMAC Studie)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Cluster Headache
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: University Ghent
First posted: 2021-07-02
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Migraine or cluster headache patients

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.

Eligibility criteria: 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

Primary outcomes:
measure: Galvanic Skin Response changes
timeFrame: 21 days
Secondary outcomes:
measure: Activity ratio
timeFrame: 21 days
measure: Skin temperature
timeFrame: 21 days
Other outcomes:
measure: Prevalence of premonitory symptoms
timeFrame: 21 days
measure: Prevalence of cranial autonomic symptoms
timeFrame: 21 days
measure: Prevalence of postdromal symptoms
timeFrame: 21 days
measure: MSQv2.1 questionnaire
timeFrame: 21 days
measure: MIDAS questionnaire
timeFrame: 21 days
measure: SF20
timeFrame: 21 days
Locations:
city: Ghent
country: Belgium
facility: University Hospital, Ghent: Department of Neurology
Study officials:
References:
citation: 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.