NCT07384351

Brief Summary

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
26mo left

Started Apr 2026

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Apr 2026Jun 2028

First Submitted

Initial submission to the registry

January 12, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 3, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

2.1 years

First QC Date

January 12, 2026

Last Update Submit

January 29, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hippocampal mean diffusivity (MD) values measured by diffusion tensor imaging (DTI) in patients with temporal lobe epilepsy and non-epileptic control subjects.

    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

Interventions

MRIDEVICE

MRI volumetry and Diffusion Tensor Imaging

Eligibility Criteria

Age12 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with idiopathic temporal lobe epilepsy and healthy volunteers

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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: 39234592BACKGROUND
  • 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: 36412515BACKGROUND
  • 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: 34917019BACKGROUND

MeSH Terms

Conditions

Epilepsy, Temporal Lobe

Condition Hierarchy (Ancestors)

Epilepsies, PartialEpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEpileptic Syndromes

Central Study Contacts

Reem Mohamed Saad, Assistant lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DR

Study Record Dates

First Submitted

January 12, 2026

First Posted

February 3, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

February 3, 2026

Record last verified: 2026-01