Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-31 @ 3:16 AM
Study NCT ID:
NCT06887504
Status:
COMPLETED
Last Update Posted:
2025-03-20
First Post:
2025-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Evaluation of White Matter Intensities in Patients with Pediatric Epilepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D049292', 'term': 'Leukoaraiosis'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 173}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2025-02-17', 'studyFirstSubmitQcDate': '2025-03-13', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Evaluation of White Matter Intensities in Patients with Pediatric Epilepsy', 'timeFrame': '01.08.2019 and 01.03.2024', 'description': 'To determine whether white matter hyperintensities are more frequent in children with epilepsy by comparing epilepsy and control groups.'}, {'measure': 'The Evaluation of White Matter Intensities in Patients with Pediatric Epilepsy', 'timeFrame': '01.08.2019 and 01.03.2024', 'description': 'Better understanding the association between pediatric epilepsy patients and white matter changes.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Children', 'epilepsy', 'white matter', 'hyperintensity'], 'conditions': ['Epilepsies', 'White Matter Alterations']}, 'descriptionModule': {'briefSummary': 'Aim: Neuroimaging is an important tool, in combination with a detailed medical history, physical examination, and electroencephalography, in the diagnosis and classification of epilepsy. White matter hyperintensities (WMHs) are bright areas of high signal intensity seen in white matter at T2-weighted MRI. Researchers aimed to evaluate whether white matter hyperintensities are more common in children with epilepsy.\n\nMaterial-method: Patients who underwent cranial MRI with diagnoses of epilepsy based on International League Against Epilepsy (ILAE) criteria at the Balıkesir University Medical Faculty Pediatric neurology clinic, Türkiye, between 01.08.2019 and 01.03.2024 and patients who underwent cranial MRI during the same period due to indications other than epilepsy, such as headache, syncope, and vertigo, were included in the study. Written informed consent was received from all patients.', 'detailedDescription': 'Aim: Neuroimaging is an important tool, in combination with a detailed medical history, physical examination, and electroencephalography, in the diagnosis and classification of epilepsy. White matter hyperintensities (WMHs) are bright areas of high signal intensity seen in white matter at T2-weighted MRI. Researchers aimed to evaluate whether white matter hyperintensities are more common in children with epilepsy.\n\nMaterial-method: Patients who underwent cranial MRI with diagnoses of epilepsy based on International League Against Epilepsy (ILAE) criteria at the Balıkesir University Medical Faculty Pediatric neurology clinic, Türkiye, between 01.08.2019 and 01.03.2024 and patients who underwent cranial MRI during the same period due to indications other than epilepsy, such as headache, syncope, and vertigo, were included in the study. Written informed consent was received from all patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '5 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study group included patients diagnosed with epilepsy who underwent cranial MRI according to the epilepsy protocol between 01.08.2019 and 01.03.2024, and the control group included patients who underwent cranial MRI according to the standard protocol for indications other than epilepsy. Patients with psychiatric disorders, a history of any chronic disease other than seizure medication, a history of vascular disease or demyelinating disease, acute symptomatic seizures or a single unprovoked seizure, incomplete file data, and MRI performed at a location other than the hospital were excluded from the study. The age and weight of patients diagnosed with epilepsy, seizure type, anti-seizure medications used, and EEG findings were recorded retrospectively from the hospital information system module, and cranial MRI images were recorded retrospectively from the PACS archive system.', 'genderDescription': 'Male and Female', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCranial MRI during the same period due to indications other than epilepsy;\n\n* headache\n* syncope and\n* vertigo\n\nExclusion Criteria:\n\nPatients with neuropsychiatric disorders;\n\n* depression,\n* psychotic disorders,\n* autism spectrum disorder History of medication use for any chronic disease other than seizure medication, History of vascular disease ;\n* Collagen tissue diseases;\n* lupus,\n* juvenile rheumatoid arthritis,\n* polyarteritis nodosa,\n* Kawasaki disease Demyelinating disease\n* acute demyelinating disease (ADEM),\n* Multiple sclerosis Acute symptomatic seizure or a single unprovoked seizure, İncomplete file data, or MRI performed at a location other than our hospital'}, 'identificationModule': {'nctId': 'NCT06887504', 'briefTitle': 'The Evaluation of White Matter Intensities in Patients with Pediatric Epilepsy', 'organization': {'class': 'OTHER', 'fullName': 'Mersin University'}, 'officialTitle': 'The Evaluation of White Matter Intensities in Patients with Pediatric Epilepsy', 'orgStudyIdInfo': {'id': 'Balikesir Univercity'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients diagnosed with epilepsy who underwent epilepsy protocol cranial MRI between 01.08.2019 and', 'description': 'All patients underwent imaging on a 1.5 T MRI device (Ingenia, release 5.3-5.7 software, Philips Medical Systems, Best, the Netherlands). The epilepsy protocol consisted of axial T1-weighted imaging (WI) spin-echo (SE)(repetition time/echo time (TR/TE): 450/15; field of view (FOV): 230 mm, slice thickness: 5 mm, matrix: 308 ×183), axial fat suppressed (FS) T1-WI SE(TR/TE: 633/15; field of view (FOV): 230 mm, slice thickness: 5 mm, matrix: 308 × 183), axial T2-WI turbo spin-echo (TSE) (TR/TE: 5240/100, FOV: 230 mm, slice thickness: 5 mm, matrix: 384 × 237), coronal FS fluid- attenuated inversion recovery (FLAIR) sequence (TR/TE: 11,000/130; FOV: 230 mm, slice thickness: 5 mm, matrix: 256 × 157), coronal T2-WI TSE (TR/TE: 3027/100; FO): 200 mm, slice thickness: 3 mm, matrix: 336 × 217), coronal T1-WI inversion recovery (IR) (TR/TE: 3079/15; field of view (FOV): 200 mm, slice thickness: 3.5 mm, matrix: 336 × 211), coronal FLAIR sequence (TR/TE: 11,000/130; FOV: 230 mm, slice thic'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33343', 'city': 'Mersin', 'state': 'Turkey', 'country': 'Turkey (Türkiye)', 'facility': 'Mersin University', 'geoPoint': {'lat': 36.81196, 'lon': 34.63886}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aysen Orman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Prof', 'investigatorFullName': 'Aysen Orman', 'investigatorAffiliation': 'Mersin University'}}}}