Menu
Not yet recruiting NCT07384351

MRI Volumetry and Diffusion Tensor Imaging in Temporal Lobe Epilepsy

Observational Temporal Lobe Epilepsy (TLE)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MRI.
Who it may be relevant to
Registry conditions: Temporal Lobe Epilepsy (TLE). Basic parameters: 12 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Added Value of MRI Volumetry and Diffusion Tensor Imaging Over Conventional MRI in Temporal Lobe Epilepsy

Overview

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.

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.

Interventions

  • Device MRI
    MRI volumetry and Diffusion Tensor Imaging

Primary outcome measures

  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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 39234592
  • 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 36412515
  • 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. PMID 34917019

Identifiers

NCT: NCT07384351 · MRI Volumetry, DTI in epilepsy

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗