Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 2:38 PM
Study NCT ID:
NCT07384351
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-03
First Post:
2026-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MRI Volumetry and Diffusion Tensor Imaging in Temporal Lobe Epilepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004833', 'term': 'Epilepsy, Temporal Lobe'}], 'ancestors': [{'id': 'D004828', 'term': 'Epilepsies, Partial'}, {'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000073376', 'term': 'Epileptic Syndromes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 78}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-29', 'studyFirstSubmitDate': '2026-01-12', 'studyFirstSubmitQcDate': '2026-01-29', 'lastUpdatePostDateStruct': {'date': '2026-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hippocampal mean diffusivity (MD) values measured by diffusion tensor imaging (DTI) in patients with temporal lobe epilepsy and non-epileptic control subjects.', 'timeFrame': 'Baseline', 'description': 'Bilateral hippocampal MD values will be measured in square millimeters per second (mm²/s) by diffusion tensor imaging (DTI). MD value of the epileptogenic hippocampus will be compared with the contralateral side and with hippocampal MD values of age- and sex-matched control subjects.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Temporal Lobe Epilepsy (TLE)']}, 'referencesModule': {'references': [{'pmid': '39234592', 'type': 'BACKGROUND', 'citation': 'Tajmirriahi M, Rabbani H. A Review of EEG-based Localization of Epileptic Seizure Foci: Common Points with Multimodal Fusion of Brain Data. J Med Signals Sens. 2024 Jul 25;14:19. doi: 10.4103/jmss.jmss_11_24. eCollection 2024.'}, {'pmid': '36412515', 'type': 'BACKGROUND', 'citation': 'Sinha N. Localizing epileptogenic tissues in epilepsy: are we losing (the) focus? Brain. 2022 Nov 21;145(11):3735-3737. doi: 10.1093/brain/awac373.'}, {'pmid': '34917019', 'type': 'BACKGROUND', 'citation': "Vinti V, Dell'Isola GB, Tascini G, Mencaroni E, Cara GD, Striano P, Verrotti A. Temporal Lobe Epilepsy and Psychiatric Comorbidity. Front Neurol. 2021 Nov 30;12:775781. doi: 10.3389/fneur.2021.775781. eCollection 2021."}]}, 'descriptionModule': {'briefSummary': 'This works aims at evaluating the diagnostic performance of combined MRI Volumetry, Diffusion tensor imaging and Conventional MRI in lateralizing the epileptogenic focus in patients with temporal lobe epilepsy and correlate these findings with clinical outcome.', 'detailedDescription': "Epilepsy is one of the most common neurological diseases. It affects about 70 million people worldwide. Temporal lobe epilepsy (TLE) is the most common focal epilepsy and its most frequent cause is hippocampal sclerosis. Approximately one-third of patients with TLE have seizures which fail to respond to drug therapy and they require surgical resection of the epileptic focus. Drug resistant epilepsy (DRE) is associated with neurocognitive and psychological decline, poor quality of life, increased risk of premature death and higher economic burden.\n\nDiagnosis of TLE typically relies on clinical evaluation, MRI to visualize affected areas, such as hippocampal sclerosis and EEG to detect abnormal electrical activity in the temporal lobe's cortical regions. However, both EEG and conventional MRI have limitations. About thirty percent of temporal lobe epilepsy (TLE) cases are negative on MRI, so quantitative diagnosis based on clinical symptoms becomes challenging.\n\nThe development of automatic MR volumetry makes it possible to account for hippocampal volume differences that may escape visual detection. MRI volumetry enables to objectively quantify brain volume changes associated with neurological conditions such as Alzheimer's disease, multiple sclerosis and epilepsy. Automated segmentation tools facilitate precise and reproducible analysis of structural brain changes, contributing significantly to early diagnosis, patient monitoring, and therapeutic planning. Progress in neuroimaging has led not only to successful identification of epileptic foci for surgical resection, but also to improve understanding of the microstructural changes in long-standing epilepsy. Diffusion tensor imaging (DTI) has the ability to characterize microstructural abnormalities in epileptic foci and to demonstrate the white matter fibers and tracts participating in the epileptic network. DTI is an MRI technique, which is based upon the ability of MRI to assess the direction and magnitude of water diffusion in tissues in vivo by utilizing the principle of anisotropic diffusion of water molecules in the white matter tracts of the brain."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with idiopathic temporal lobe epilepsy and healthy volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with different age groups having temporal lobe epilepsy diagnosed by EEG with no detected structural brain lesion by conventional MRI other than mesial temporal sclerosis.\n\nExclusion Criteria:\n\n* Contraindications for MRI as claustrophobia, cardiac pacemaker and non-compatible metallic devices.\n* Patients with suboptimal images or techniques.\n* Post-operative and post-head traumatic cases.'}, 'identificationModule': {'nctId': 'NCT07384351', 'briefTitle': 'MRI Volumetry and Diffusion Tensor Imaging in Temporal Lobe Epilepsy', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Added Value of MRI Volumetry and Diffusion Tensor Imaging Over Conventional MRI in Temporal Lobe Epilepsy', 'orgStudyIdInfo': {'id': 'MRI Volumetry, DTI in epilepsy'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MRI', 'type': 'DEVICE', 'description': 'MRI volumetry and Diffusion Tensor Imaging'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Reem Mohamed Saad, Assistant lecturer', 'role': 'CONTACT', 'email': 'saadreem89@gmail.com', 'phone': '+201014122696'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DR', 'investigatorFullName': 'Reem Mohamed Saad EL Shazly', 'investigatorAffiliation': 'Assiut University'}}}}