Temporal Lobe Epilepsy (TLE)NCT07384351
MRI Volumetry and Diffusion Tensor Imaging in Temporal Lobe Epilepsy
An observational study of Temporal Lobe Epilepsy (TLE), run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporal Lobe Epilepsy (TLE)
- What is being tested?
- MRI
- Type of treatment
- Medical device
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 30 Jun 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients with idiopathic temporal lobe epilepsy and healthy volunteers
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Added Value of MRI Volumetry and Diffusion Tensor Imaging Over Conventional MRI in Temporal Lobe Epilepsy
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.
Read the 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.
- Conditions
- Temporal Lobe Epilepsy (TLE)
- Being tested
- MRI
- Medical subject headings
- Epilepsy, Temporal Lobe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
MRI volumetry and Diffusion Tensor Imaging
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 Apr 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Temporal Lobe Epilepsy (TLE)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 78 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reem Mohamed Saad EL Shazly, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384351
- Sponsor's protocol ID
- MRI Volumetry, DTI in epilepsy
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 39234592Sinha N. Localizing epileptogenic tissues in epilepsy: are we losing (the) focus? Brain. 2022 Nov 21;145(11):3735-3737. doi: 10.1093/brain/awac373.
PubMed 36412515Vinti 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.
PubMed 34917019
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Added Value of MRI Volumetry and Diffusion Tensor Imaging Over Conventional MRI in Temporal Lobe Epilepsy
- ClinicalTrials.gov ID
- NCT07384351
- Acronym / sponsor ID
- MRI Volumetry, DTI in epilepsy
- Conditions
- Temporal Lobe Epilepsy (TLE)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 12 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients with idiopathic temporal lobe epilepsy and healthy volunteers
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIMRI volumetry and Diffusion Tensor Imaging | Device | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Background: PubMed 39234592Tajmirriahi 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.
- Background: PubMed 36412515Sinha N. Localizing epileptogenic tissues in epilepsy: are we losing (the) focus? Brain. 2022 Nov 21;145(11):3735-3737. doi: 10.1093/brain/awac373.
- Background: PubMed 34917019Vinti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Temporal Lobe Epilepsy (TLE), run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reem Mohamed Saad, Assistant lecturer (+201014122696, saadreem89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07384351, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.