Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:50 PM
Study NCT ID:
NCT06461767
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Repetitive Transcranial Magnetic Stimulation in Treatment and Prophylaxis of Chronic Migraine in Patients With no Prophylactic Treatment for the Last 3 Months
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'the patient will divide into 4 groups first group will receive stimulation over the left motor cortex second group will receive stimulation over left dorsolateral prefrontal cortex third group will receive stimulation over both left motor cortex and left dorsolateral prefrontal cortex fourth group will receive sham stimulation'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-14', 'studyFirstSubmitDate': '2024-06-11', 'studyFirstSubmitQcDate': '2024-06-11', 'lastUpdatePostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'improvement of headache severity and number of attacks of headache before and after intervention by visual analogue scale and headache impact test', 'timeFrame': 'one month after treatment', 'description': 'improvement of headache severity and number of attacks of headache before and after intervention by visual analogue scale and headache impact test'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Migraine']}, 'descriptionModule': {'briefSummary': 'Compared with the patients with episodic migraine those with chronic migraine have worst quality of life and more severe headache related disability we investigate Repetitive transcranial magnetic stimulation in treatment and prophylaxis of chronic migraine'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* A study sample of patients with chronic migraine according to international classification of headache disorders-3 (ICHD-3).\n* Patients are regular on follow up visits.\n\nExclusion criteria:\n\n* Patients with depression by Hamiliton scale of depression by using its Arabic version Translated by Dr Lotfy Fateem\n* patients on prophylactic medications for chronic migraine.\n* pregnancy.\n* cochlear implants, cardiac pacemaker, and metal body implanted in head-and-neck region.\n* Patients refused to give informed consent.\n* History of seizures.'}, 'identificationModule': {'nctId': 'NCT06461767', 'acronym': 'rTMS', 'briefTitle': 'Repetitive Transcranial Magnetic Stimulation in Treatment and Prophylaxis of Chronic Migraine in Patients With no Prophylactic Treatment for the Last 3 Months', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Repetitive Transcranial Magnetic Stimulation in Treatment of Chronic Migraine', 'orgStudyIdInfo': {'id': 'Soh-Med-24-05-06MS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group (1) will rTMS over left motor cortex', 'description': 'Repetitive transcranial magnetic stimulation parameters:\n\nstimulation site: left motor cortex intensity: 70% of resting motor threshold frequency: 15 Hz number of pulses: 30 number of trains: 40', 'interventionNames': ['Device: transcranial magnetic stimulation device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group (2) will receive rTMS over left dorsolateral prefrontal cortex', 'description': 'Repetitive transcranial magnetic stimulation parameters:\n\nstimulation site: left dorsolateral prefrontal cortex intensity: 70% of resting motor threshold frequency: 15 Hz number of pulses: 30 number of trains: 40', 'interventionNames': ['Device: transcranial magnetic stimulation device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group (3) will receive rTMS over left dorsolateral prefrontal cortex and left motor cortex', 'description': 'Repetitive transcranial magnetic stimulation parameters:\n\nstimulation site: left dorsolateral prefrontal cortex and left motor cortex intensity: 70% of resting motor threshold frequency: 15 Hz number of pulses: 30 number of trains: 40', 'interventionNames': ['Device: transcranial magnetic stimulation device']}, {'type': 'SHAM_COMPARATOR', 'label': 'group (4) will receive sham stimulation', 'description': 'Repetitive transcranial magnetic stimulation parameters:\n\nstimulation site: the coil will be perpendicular over vertex of skull intensity: 70% of resting motor threshold frequency: 15 Hz number of pulses: 30 number of trains: 40', 'interventionNames': ['Device: transcranial magnetic stimulation device']}], 'interventions': [{'name': 'transcranial magnetic stimulation device', 'type': 'DEVICE', 'description': 'Repetitive transcranial magnetic stimulation parameters:\n\nstimulation site: left dorsolateral prefrontal cortex and left motor cortex intensity: 70% of resting motor threshold frequency: 15 Hz number of pulses: 30', 'armGroupLabels': ['group (1) will rTMS over left motor cortex', 'group (2) will receive rTMS over left dorsolateral prefrontal cortex', 'group (3) will receive rTMS over left dorsolateral prefrontal cortex and left motor cortex', 'group (4) will receive sham stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02', 'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Tarek Mohamed', 'role': 'CONTACT', 'email': 'tarikmohamed@med.sohag.edu.eg', 'phone': '01025545002'}], 'facility': 'Sohag faculty of medicine', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Tarek Mohamed', 'role': 'CONTACT', 'email': 'tarikmohamed@med.sohag.edu.eg', 'phone': '01025545002'}], 'overallOfficials': [{'name': 'Tarek Mohamed', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sohag faculty of medicine'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Tarik Mohamed Abdelnaeem', 'investigatorAffiliation': 'Sohag University'}}}}