Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-30 @ 1:36 PM
Study NCT ID:
NCT06868251
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-10
First Post:
2025-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence and Pattern of Headache in Pediatric Epilepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D006261', 'term': 'Headache'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-07', 'studyFirstSubmitDate': '2025-03-07', 'studyFirstSubmitQcDate': '2025-03-07', 'lastUpdatePostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'headache prevelance', 'timeFrame': '1 month', 'description': 'To estimate the prevalence and characters of headache in pediatric epileptic patients'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['epilepsy', 'headache', 'pediatric epilepsy'], 'conditions': ['Headache Disorders', 'Epilepsy']}, 'descriptionModule': {'briefSummary': "This study aims to determine the prevalence and characteristics of headaches in children with epilepsy, aged 5-18 years. Approximately 60 children will participate at Assiut University Children's Hospital. The research will involve medical history collection, physical and neurological exams, EEG review, and blood tests. The study seeks to improve understanding of the relationship between epilepsy and headaches in children, potentially leading to better treatment strategies. Participation is voluntary, and the risks are minimal.", 'detailedDescription': 'The primary aim of this observational cross-sectional study is to estimate the prevalence and characterize headaches in pediatric epilepsy patients. Secondary objectives include identifying potential risk factors and triggers associated with headaches in this population and assessing their impact on quality of life.\n\nParticipant Criteria\n\nInclusion criteria:\n\nChildren aged 5-18 years with epilepsy\n\nMentally normal and able to describe symptoms\n\nWilling to participate in the study\n\nExclusion criteria:\n\nChildren unable to express symptoms due to mental retardation, psychiatric illness, or verbal disability\n\nChildren or parents who refuse to participate\n\nMethodology Sample Size: 60 patients, calculated using Epi-info version 7 software, based on a previous study showing 45.7% headache prevalence in pediatric epilepsy patients.\n\nData Collection:\n\nDetailed medical history, including neurological, cardiovascular, gastrointestinal, endocrine, and musculoskeletal aspects\n\nComprehensive headache history (onset, location, intensity, quality, duration, frequency, associated symptoms)\n\nEpilepsy history (age of onset, duration, type, medication, seizure control)\n\nGeneral physical examination\n\nNeurological examination\n\nInvestigations:\n\nElectroencephalogram (EEG) using Nihon Kohden model 1200\n\nNeuroimaging studies (MRI, CT) if available\n\nComplete Blood Count (CBC)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '5 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'pediatric epilepsy patients (5:18 years of age) who are mentally normal and can describe their symptoms and have epilepsy', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- pediatric epilepsy patients (5:18 years of age) who are mentally normal and can describe their symptoms.\n\n2/ Acceptance to participate in this study.\n\nExclusion Criteria:\n\n\\- / Children who can't express their symptoms properly because of mental retardation, psychiatric illness or verbal disability.\n\n2/ Children or Parents who refused to participate in this study."}, 'identificationModule': {'nctId': 'NCT06868251', 'briefTitle': 'Prevalence and Pattern of Headache in Pediatric Epilepsy', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Prevalence and Pattern of Comorbid Headache in Pediatric Epilepsy Patients Attending Assiut University Children Hospital.', 'orgStudyIdInfo': {'id': 'headache in pediatric epilipsy'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'pediatric epilepsy patients with headache', 'description': 'This group consists of children aged 5-18 years with diagnosed epilepsy who are mentally normal and can describe their symptoms. The study aims to estimate the prevalence and characteristics of headache in these patients. Participants will undergo a comprehensive evaluation including medical history, physical and neurological examinations, and investigations such as EEG and neuroimaging. The research will assess various aspects of headache in relation to epilepsy, including onset, location, intensity, duration, and relationship to seizures, to better understand the comorbidity between headache and epilepsy in pediatric patients.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident at the pediatrics department', 'investigatorFullName': 'Somia Rasheed Abdelrasoul', 'investigatorAffiliation': 'Assiut University'}}}}