EpilepsiesNCT06887504
The Evaluation of White Matter Intensities in Patients with Pediatric Epilepsy
An observational study of Epilepsies and White Matter Alterations, run by Aysen Orman at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsies, White Matter Alterations
- How many people
- 173 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2019to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 5 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Cranial MRI during the same period due to indications other than epilepsy;
- headache
- syncope and
- vertigo
Who cannot join
- 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,
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Epilepsies, White Matter Alterations
- Keywords
- Children, epilepsy, white matter, hyperintensity
- Medical subject headings
- Epilepsy, Leukoaraiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
The Evaluation of White Matter Intensities in Patients with Pediatric Epilepsy
To determine whether white matter hyperintensities are more frequent in children with epilepsy by comparing epilepsy and control groups.
Measured: 01.08.2019 and 01.03.2024
The Evaluation of White Matter Intensities in Patients with Pediatric Epilepsy
Better understanding the association between pediatric epilepsy patients and white matter changes.
Measured: 01.08.2019 and 01.03.2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start1 Aug 2019
- Primary completion1 Mar 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsiesStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aysen Orman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aysen Orman, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887504
- Sponsor's protocol ID
- Balikesir Univercity
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of White Matter Intensities in Patients with Pediatric Epilepsy
- ClinicalTrials.gov ID
- NCT06887504
- Acronym / sponsor ID
- Balikesir Univercity
- Conditions
- Epilepsies, White Matter Alterations
- Keywords
- Children, epilepsy, white matter, hyperintensity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Aysen OrmanUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 20 Mar 2025 (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.
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
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- Cranial MRI during the same period due to indications other than epilepsy;
- headache
- syncope and
- vertigo
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsies and White Matter Alterations, run by Aysen Orman at 1 site in Turkey (Türkiye).
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 4 inclusion and 11 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: finished, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Evaluation of White Matter Intensities in Patients with Pediatric Epilepsy (time frame: 01.08.2019 and 01.03.2024). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2025.