Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-01-01 @ 7:35 AM
Study NCT ID:
NCT04949204
Status:
COMPLETED
Last Update Posted:
2022-12-05
First Post:
2021-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Context-awareness, Physiological Monitoring, and Machine Learning in Migraine and Cluster Headache
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D003027', 'term': 'Cluster Headache'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D051303', 'term': 'Trigeminal Autonomic Cephalalgias'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-02', 'studyFirstSubmitDate': '2021-06-24', 'studyFirstSubmitQcDate': '2021-06-24', 'lastUpdatePostDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'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', 'description': 'In migraine patients'}, {'measure': 'MIDAS questionnaire', 'timeFrame': '21 days', 'description': 'In migraine patients'}, {'measure': 'SF20', 'timeFrame': '21 days', 'description': 'In migraine and cluster headache patients'}], 'primaryOutcomes': [{'measure': 'Galvanic Skin Response changes', 'timeFrame': '21 days', 'description': 'Changes in GSR through the different phases of the headache attacks'}], 'secondaryOutcomes': [{'measure': 'Activity ratio', 'timeFrame': '21 days', 'description': 'Activity ratio measurement through accelerometer data'}, {'measure': 'Skin temperature', 'timeFrame': '21 days', 'description': 'Skin temperature measurement through builtin thermometer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Migraine', 'Cluster Headache']}, 'referencesModule': {'references': [{'pmid': '38376015', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '35361224', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Migraine or cluster headache patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* migraine or cluster headache diagnosis based on ICHD 3 criteria\n* at least 2 attacks each month\n* onset of headache syndrome before the age of 50\n* if multiple headache syndromes coexist: attacks are clearly distinguishable\n* participant has smartphone that he/she wants to apply for this research\n\nExclusion Criteria:\n\n* chronic migraine patients\n* history of alcohol or illicit drug abuse\n* significant medical comorbidity deemed by the investigator to interfere with the study\n* use of betablockers\n* participating in other academic or commercial trials'}, 'identificationModule': {'nctId': 'NCT04949204', 'acronym': 'COPIMAC', 'briefTitle': 'Context-awareness, Physiological Monitoring, and Machine Learning in Migraine and Cluster Headache', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Contextuele Analyse, Fysiologische Metingen en Machinaal Leren Voor Migraine en Clusterhoofdpijn (COPIMAC Studie)', 'orgStudyIdInfo': {'id': 'BC-07403'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Migraine patients', 'description': 'Wearable wrist sensor + headache application on smartphone', 'interventionNames': ['Procedure: Wearable sensor detection']}, {'label': 'Cluster Headache Patients', 'description': 'Wearable wrist sensor + headache application on smartphone', 'interventionNames': ['Procedure: Wearable sensor detection']}], 'interventions': [{'name': 'Wearable sensor detection', 'type': 'PROCEDURE', 'description': 'Empatica E4 wearable wrist sensor', 'armGroupLabels': ['Cluster Headache Patients', 'Migraine patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'University Hospital, Ghent: Department of Neurology', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Ghent', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}