- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07384351
MRI Volumetry and Diffusion Tensor Imaging in Temporal Lobe Epilepsy
Added Value of MRI Volumetry and Diffusion Tensor Imaging Over Conventional MRI in Temporal Lobe Epilepsy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Diagnosis 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.
The 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Reem Mohamed Saad, Assistant lecturer
- Phone Number: +201014122696
- Email: saadreem89@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Contraindications for MRI as claustrophobia, cardiac pacemaker and non-compatible metallic devices.
- Patients with suboptimal images or techniques.
- Post-operative and post-head traumatic cases.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hippocampal mean diffusivity (MD) values measured by diffusion tensor imaging (DTI) in patients with temporal lobe epilepsy and non-epileptic control subjects.
Time Frame: Baseline
|
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.
|
Baseline
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Caseload survey: CCM certification ranks first. Hosp Case Manag. 2001 Jun;9(6):85-6, 93, 81-2.
- Wang Y, Spatz MK, Kannan K, Hayk H, Avivi A, Gorivodsky M, Pines M, Yayon A, Lonai P, Givol D. A mouse model for achondroplasia produced by targeting fibroblast growth factor receptor 3. Proc Natl Acad Sci U S A. 1999 Apr 13;96(8):4455-60. doi: 10.1073/pnas.96.8.4455.
- Clark JE, Cant AJ. Lymphadenopathy. Arch Dis Child. 1996 Apr;74(4):368. doi: 10.1136/adc.74.4.368-a. No abstract available.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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 Volumetry, DTI in epilepsy
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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