- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03643471
Advanced Magnetic Resonance Imaging in Temporal Lobe Epilepsy
Role of Advanced Magnetic Resonance Imaging in Diagnosis of Idiopathic Temporal Lobe Epilepsy
Study Overview
Detailed Description
Patients with history of partial seizures with or without secondary generalization attending at outpatient clinic or admitted at Neurology department of Assuit University Hospital will be included in the study MRI study will be done for each patient. MR imaging will be performed on a 1.5-T MR imaging unit (Siemens, Sembra medical system,German).
Prospectively completed data forms will be analyzed and compared. Statistical tests appropriate to the nature of the data will be used.
All patients will not be subjected to risk of any kind during this study. All patients' data will be confidentially kept. Approval of the ethical committee of Faculty of Medicine, Assiut University.
An informed consent will be taken from all patients included in this study. The research will be conducted only by scientifically qualified and trained personnel.
The procedures included in this study have been already used in hospital and centers in and outside Egypt
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Assiut, Egypt
- Recruiting
- Assiut University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
patients with history of partial seizures with or without secondary generalization attending at outpatient clinic or admitted at Neurology department of Assuit University Hospital will be included in the study based on the following criteria:
- Clinical features consistent with seizures of temporal lobe origin.
- Focal ictal temporal lobe patterns recorded with EEG.
- No lesion detected by conventional MR imaging other than mesial temporal sclerosis.
Exclusion Criteria:
- Any general contraindication of MRI in some cases as presence of para magnetic substance as pacemakers or in patients with claustrophobia.
- Subjects with age less than 12 year old.
- Patients with any structural lesion other than mesial temporal sclerosis identified on MR brain imaging.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Calculating the sensitivity,specificity and accuracy of hippocampal volumetry , T2 relaxometry , MR spectroscopy and diffusion tensor imaging in identification and lataeralization of epileptogenic focus
Time Frame: baseline
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baseline
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Muhlhofer W, Tan YL, Mueller SG, Knowlton R. MRI-negative temporal lobe epilepsy-What do we know? Epilepsia. 2017 May;58(5):727-742. doi: 10.1111/epi.13699. Epub 2017 Mar 7.
- Crocker CE, Pohlmann-Eden B, Schmidt MH. Role of neuroimaging in first seizure diagnosis. Seizure. 2017 Jul;49:74-78. doi: 10.1016/j.seizure.2016.05.015. Epub 2016 Jun 1.
- Ruber T, David B, Elger CE. MRI in epilepsy: clinical standard and evolution. Curr Opin Neurol. 2018 Apr;31(2):223-231. doi: 10.1097/WCO.0000000000000539.
- Chinchure S, Kesavadas C, Thomas B. Structural and functional neuroimaging in intractable epilepsy. Neurol India. 2010 May-Jun;58(3):361-70. doi: 10.4103/0028-3886.65569.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MRI in temporal lobe epilepsy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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