Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University Ghent | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Migraine patients | Wearable wrist sensor + headache application on smartphone |
| |
| Cluster Headache Patients | Wearable wrist sensor + headache application on smartphone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wearable sensor detection | Procedure | Empatica E4 wearable wrist sensor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Galvanic Skin Response changes | Changes in GSR through the different phases of the headache attacks | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Activity ratio | Activity ratio measurement through accelerometer data | 21 days |
| Skin temperature | Skin temperature measurement through builtin thermometer |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of premonitory symptoms | 21 days | |
| Prevalence of cranial autonomic symptoms | 21 days | |
| Prevalence of postdromal symptoms |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Migraine or cluster headache patients
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Ghent: Department of Neurology | Ghent | 9000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38376015 | Derived | Vandenbussche N, Van Der Donckt J, De Brouwer M, Steenwinckel B, Stojchevska M, Ongenae F, Van Hoecke S, Paemeleire K. Patients with chronic cluster headache may show reduced activity energy expenditure on ambulatory wrist actigraphy recordings during daytime attacks. Brain Behav. 2024 Jan;14(1):e3360. doi: 10.1002/brb3.3360. | |
| 35361224 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D003027 | Cluster Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 21 days |
| 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 |
| 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. |
| D009422 | Nervous System Diseases |
| D051303 | Trigeminal Autonomic Cephalalgias |