Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-01-01 @ 9:42 PM
Study NCT ID:
NCT06798259
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-29
First Post:
2025-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autonomic Dysfunction in Patients With Migraine: Cardiovascular and Neurophysiology Assessment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 116}, 'targetDuration': '2 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-22', 'studyFirstSubmitDate': '2025-01-07', 'studyFirstSubmitQcDate': '2025-01-22', 'lastUpdatePostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Autonomic dysfunction in patients with migraine', 'timeFrame': 'baseline', 'description': 'assessment of autonomic dysfunction using Composite autonomic system Score 31'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular assessment', 'timeFrame': '24 hours', 'description': 'Cardiovascular is done using Holter monitoring and table tilt est'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Migraine Headache']}, 'descriptionModule': {'briefSummary': 'Autonomic dysfunction in patients with migraine: cardiovascular and neurophysiology assessment.', 'detailedDescription': 'assessment if Autonomic dysfunction in patients with migraine by using cardiovascular assessment by HOTLER MONITORING and table tilt test and neurophysiology assessment by sympathetic skin response'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '. The patients will be recruited from the Neurology clinic, Beni Suef University Hospital.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1.fulfilling ICHD-3 criteria for migraine 2. migraine for at least 3 months.\n\nExclusion Criteria:\n\nbrain imaging showing structural brain lesions. .medications that could impact autonomic function such as tricyclic antidepressants, anticholinergics, or opioids.\n\n* Patients with concomitant medical illness causing autonomic dysfunction such as: diabetes, cardiovascular, demyelinating or degenerative neurological disorders.\n* Contraindications for performing the tilt test\n* Pregnant patients.'}, 'identificationModule': {'nctId': 'NCT06798259', 'briefTitle': 'Autonomic Dysfunction in Patients With Migraine: Cardiovascular and Neurophysiology Assessment', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': 'Autonomic Dysfunction in Patients With Migraine: Cardiovascular and Neurophysiology Assessment', 'orgStudyIdInfo': {'id': 'FMBSUREC/01102024/Abd-Elsadek'}}, 'contactsLocationsModule': {'locations': [{'zip': '20', 'city': 'Benisuef', 'state': 'Benisuef', 'country': 'Egypt', 'facility': 'Benisuef university hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beni-Suef University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant teacher of anesthesiology ,pain management and surgical ICU departement', 'investigatorFullName': 'Donia Adel Abd-ElSadek', 'investigatorAffiliation': 'Beni-Suef University'}}}}