Cluster Headache, Migraine
Conditions
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.
Interventions
PROCEDUREWearable sensor detection
Empatica E4 wearable wrist sensor
Sponsors
University Ghent
University Hospital, Ghent
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Galvanic Skin Response changes | 21 days | Changes in GSR through the different phases of the headache attacks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin temperature | 21 days | Skin temperature measurement through builtin thermometer |
| Activity ratio | 21 days | Activity ratio measurement through accelerometer data |
Other
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of postdromal symptoms | 21 days | — |
| MSQv2.1 questionnaire | 21 days | In migraine patients |
| MIDAS questionnaire | 21 days | In migraine patients |
| SF20 | 21 days | In migraine and cluster headache patients |
| Prevalence of premonitory symptoms | 21 days | — |
| Prevalence of cranial autonomic symptoms | 21 days | — |
Countries
Belgium
Outcome results
None listed