The Evaluation of White Matter Intensities in Patients with Pediatric Epilepsy

March 13, 2025 updated by: Aysen Orman

Aim: Neuroimaging is an important tool, in combination with a detailed medical history, physical examination, and electroencephalography, in the diagnosis and classification of epilepsy. White matter hyperintensities (WMHs) are bright areas of high signal intensity seen in white matter at T2-weighted MRI. Researchers aimed to evaluate whether white matter hyperintensities are more common in children with epilepsy.

Material-method: Patients who underwent cranial MRI with diagnoses of epilepsy based on International League Against Epilepsy (ILAE) criteria at the Balıkesir University Medical Faculty Pediatric neurology clinic, Türkiye, between 01.08.2019 and 01.03.2024 and patients who underwent cranial MRI during the same period due to indications other than epilepsy, such as headache, syncope, and vertigo, were included in the study. Written informed consent was received from all patients.

Study Overview

Status

Completed

Detailed Description

Aim: Neuroimaging is an important tool, in combination with a detailed medical history, physical examination, and electroencephalography, in the diagnosis and classification of epilepsy. White matter hyperintensities (WMHs) are bright areas of high signal intensity seen in white matter at T2-weighted MRI. Researchers aimed to evaluate whether white matter hyperintensities are more common in children with epilepsy.

Material-method: Patients who underwent cranial MRI with diagnoses of epilepsy based on International League Against Epilepsy (ILAE) criteria at the Balıkesir University Medical Faculty Pediatric neurology clinic, Türkiye, between 01.08.2019 and 01.03.2024 and patients who underwent cranial MRI during the same period due to indications other than epilepsy, such as headache, syncope, and vertigo, were included in the study. Written informed consent was received from all patients.

Study Type

Observational

Enrollment (Actual)

173

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Mersin, Turkey, 33343
        • Mersin University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The study group included patients diagnosed with epilepsy who underwent cranial MRI according to the epilepsy protocol between 01.08.2019 and 01.03.2024, and the control group included patients who underwent cranial MRI according to the standard protocol for indications other than epilepsy. Patients with psychiatric disorders, a history of any chronic disease other than seizure medication, a history of vascular disease or demyelinating disease, acute symptomatic seizures or a single unprovoked seizure, incomplete file data, and MRI performed at a location other than the hospital were excluded from the study. The age and weight of patients diagnosed with epilepsy, seizure type, anti-seizure medications used, and EEG findings were recorded retrospectively from the hospital information system module, and cranial MRI images were recorded retrospectively from the PACS archive system.

Description

Inclusion Criteria:

Cranial MRI during the same period due to indications other than epilepsy;

  • headache
  • syncope and
  • vertigo

Exclusion Criteria:

Patients with neuropsychiatric disorders;

  • depression,
  • psychotic disorders,
  • autism spectrum disorder History of medication use for any chronic disease other than seizure medication, History of vascular disease ;
  • Collagen tissue diseases;
  • lupus,
  • juvenile rheumatoid arthritis,
  • polyarteritis nodosa,
  • Kawasaki disease Demyelinating disease
  • acute demyelinating disease (ADEM),
  • Multiple sclerosis Acute symptomatic seizure or a single unprovoked seizure, İncomplete file data, or MRI performed at a location other than our hospital

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients diagnosed with epilepsy who underwent epilepsy protocol cranial MRI between 01.08.2019 and
All patients underwent imaging on a 1.5 T MRI device (Ingenia, release 5.3-5.7 software, Philips Medical Systems, Best, the Netherlands). The epilepsy protocol consisted of axial T1-weighted imaging (WI) spin-echo (SE)(repetition time/echo time (TR/TE): 450/15; field of view (FOV): 230 mm, slice thickness: 5 mm, matrix: 308 ×183), axial fat suppressed (FS) T1-WI SE(TR/TE: 633/15; field of view (FOV): 230 mm, slice thickness: 5 mm, matrix: 308 × 183), axial T2-WI turbo spin-echo (TSE) (TR/TE: 5240/100, FOV: 230 mm, slice thickness: 5 mm, matrix: 384 × 237), coronal FS fluid- attenuated inversion recovery (FLAIR) sequence (TR/TE: 11,000/130; FOV: 230 mm, slice thickness: 5 mm, matrix: 256 × 157), coronal T2-WI TSE (TR/TE: 3027/100; FO): 200 mm, slice thickness: 3 mm, matrix: 336 × 217), coronal T1-WI inversion recovery (IR) (TR/TE: 3079/15; field of view (FOV): 200 mm, slice thickness: 3.5 mm, matrix: 336 × 211), coronal FLAIR sequence (TR/TE: 11,000/130; FOV: 230 mm, slice thic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Evaluation of White Matter Intensities in Patients with Pediatric Epilepsy
Time Frame: 01.08.2019 and 01.03.2024
To determine whether white matter hyperintensities are more frequent in children with epilepsy by comparing epilepsy and control groups.
01.08.2019 and 01.03.2024
The Evaluation of White Matter Intensities in Patients with Pediatric Epilepsy
Time Frame: 01.08.2019 and 01.03.2024
Better understanding the association between pediatric epilepsy patients and white matter changes.
01.08.2019 and 01.03.2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Actual)

March 1, 2024

Study Completion (Actual)

April 1, 2024

Study Registration Dates

First Submitted

February 17, 2025

First Submitted That Met QC Criteria

March 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 13, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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