- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06887504
The Evaluation of White Matter Intensities in Patients with Pediatric Epilepsy
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
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Mersin, Turkey, 33343
- Mersin University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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The Evaluation of White Matter Intensities in Patients with Pediatric Epilepsy
Time Frame: 01.08.2019 and 01.03.2024
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To determine whether white matter hyperintensities are more frequent in children with epilepsy by comparing epilepsy and control groups.
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01.08.2019 and 01.03.2024
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The Evaluation of White Matter Intensities in Patients with Pediatric Epilepsy
Time Frame: 01.08.2019 and 01.03.2024
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Better understanding the association between pediatric epilepsy patients and white matter changes.
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01.08.2019 and 01.03.2024
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Balikesir Univercity
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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