Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2026-02-22 @ 12:37 PM
Study NCT ID:
NCT06445595
Status:
RECRUITING
Last Update Posted:
2024-10-15
First Post:
2024-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relationship Between Obesity and Chronic Headache
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-10', 'studyFirstSubmitDate': '2024-05-31', 'studyFirstSubmitQcDate': '2024-05-31', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The relationship between Bady Mass Index (BMI) and the development of chronic headache', 'timeFrame': 'Postoperative 3 month.', 'description': 'BMI is calculated by dividing weight in kilograms by the square of height in metres.'}], 'secondaryOutcomes': [{'measure': 'The relationship between the nature of trauma and the development of chronic headache', 'timeFrame': 'Postoperative 3 month.', 'description': 'Head traumas that occur due to different reasons will be examined'}, {'measure': "The relationship between patients' education levels and chronic headache", 'timeFrame': 'Postoperative 3 month', 'description': 'Education levels will be defined as primary school, secondary school and university graduate.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': 'The relationship between obesity and the development of chronic headache after traumatic brain injury will be investigated.', 'detailedDescription': 'Traumatic brain injury (TBI) can be defined as an injury caused by an external force, particularly a direct blow to the head or exposure to a shock wave. In addition to the well-known consequences of TBI, including cognitive changes, motor deficits and sensory abnormalities, available evidence suggests that acute and chronic pain is also common after TBI. Obesity and TBI can be considered as public health problems with their increasing prevalence in recent years. Chronic pain adds to the already enormous clinical, psychological, social and economic burden of obesity. Developing mechanisms to prevent the development of pain after TBI has attracted the attention of researchers. Obesity is a preventable and modifiable clinical condition. The extent to which obesity may create adverse conditions after TBI remains unclear.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'individuals over the age of 18 who suffered a head injury', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals over the age of 18 who suffered a head injury\n\nExclusion Criteria:\n\n* People with severe head trauma\n* Those who do not speak Turkish\n* Those with a history of chronic opioid user\n* Those with alcohol and drug addiction'}, 'identificationModule': {'nctId': 'NCT06445595', 'briefTitle': 'The Relationship Between Obesity and Chronic Headache', 'organization': {'class': 'OTHER', 'fullName': 'Karaman Training and Research Hospital'}, 'officialTitle': 'Investigation of the Effectiveness of Obesity in the Development of Chronic Headache After Traumatic Brain Injury', 'orgStudyIdInfo': {'id': '05-2024/19'}}, 'armsInterventionsModule': {'interventions': [{'name': 'patients with traumatic brain injury', 'type': 'OTHER', 'otherNames': ['Patients will be contacted by phone'], 'description': 'Patients will be contacted by phone'}]}, 'contactsLocationsModule': {'locations': [{'zip': '70200', 'city': 'Karaman', 'state': 'Merkez', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Hatice Toprak', 'role': 'CONTACT', 'email': 'dr.tprk@hotmail.com', 'phone': '05357827688'}], 'facility': 'Karaman Training and Research Hospital', 'geoPoint': {'lat': 37.18111, 'lon': 33.215}}], 'centralContacts': [{'name': 'Hatice Toprak', 'role': 'CONTACT', 'email': 'dr.tprk@hotmail.com', 'phone': '05357827688'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Sharing will be evaluated in cases where the responsible researcher is contacted.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karaman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'asst. prof', 'investigatorFullName': 'HATİCE TOPRAK', 'investigatorAffiliation': 'Karaman Training and Research Hospital'}}}}