The Evaluation of White Matter Intensities in Patients with Pediatric Epilepsy

NCT ID: NCT06887504

Last Updated: 2025-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

173 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-01

Study Completion Date

2024-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Epilepsies White Matter Alterations

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

5 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Aysen Orman

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Aysen Orman

Associate Prof

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mersin University

Mersin, Turkey, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Balikesir Univercity

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Role of MRS in Brain Lesions
NCT05565690 UNKNOWN