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NCT03318237 · ClinicalTrials.gov registry record

Ultra High Field MRI of Focal Pediatric Epilepsy

A clinical trial, sponsored by Johns Hopkins University.

Terminated
Registry status
2
Enrollment target

NCT03318237: Clinical Trial study, sponsored by Johns Hopkins University.

NCT03318237 is a clinical trial that was terminated before completion, run by Johns Hopkins University. The registered enrollment target is 2 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03318237 was terminated before completion, sponsored by Johns Hopkins University.

TERMINATED
Registry status
2 participants
Enrollment target

Study Summary

Epilepsy affects a significant number of children in the United States. The majority of patients achieve control of their seizures by conventional treatment strategies including medications. However, one third of patients do not achieve satisfactory seizure control with medications alone. Ketogenic diet and lifestyle modifications may also be tried. In some of these children, the seizure focus can be localized to one area of the brain and the seizures are resistant to conservative treatment strategies. These children may have subtle structural/developmental abnormalities in their brain, the most frequent of which is focal cortical dysplasia. These are localized areas of abnormal lamination of the cerebral cortex that can be extremely subtle and difficult to detect, even with state of the art magnetic resonance imaging (MRI). More importantly, these lesions may be amenable to surgical resection resulting in marked decrease in frequency or even resolution of seizures. MRI is a noninvasive imaging modality without ionizing radiation that has played a central role in the assessment of anatomy, physiology/pathophysiology of children with epilepsy. It is particularly useful in children with refractory focal epilepsy. Prior studies have shown that high resolution, high-field (3T) MR imaging of the brain helps to identify subtle focal epileptogenic abnormalities, including focal cortical dysplasia, in some patients. However, there is scarce data directly comparing the performance of ultra high-field (7T) MRI, currently an investigative technique offering optimized contrast and signal-to-noise rations and superior spatial resolution, with clinically available 3T MR imaging. The purpose of this study is to evaluate whether ultra high-field (7T) MR imaging improves detection and characterization of subtle structural epileptogenic abnormalities in children with focal epilepsy. The importance of this research is that identification of a focal epileptogenic lesion in children

Primary Outcome

The rate of abnormal findings detected by 7T MRI in children with focal epilepsy will be recorded, as well as their location and relationship with abnormal electroencephalographic (EEG) findings. These findings include areas of malformation or scarring (dysplasia or gliosis) in the cerebral cortex, for example.

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2018-05-01
Est. Completion 2018-11-30
Johns Hopkins University

1,448 total trials

Why NCT03318237 stopped before completion

NCT03318237 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 2 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT03318237 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03318237 about?

NCT03318237 is a clinical study titled "Ultra High Field MRI of Focal Pediatric Epilepsy". Epilepsy affects a significant number of children in the United States. The majority of patients achieve control of their seizures by conventional treatment strategies including medications. However, one third of patients do not achieve satisfactory seizure control with medications alone. Ketogenic ...

What is the current status of trial NCT03318237?

This trial is currently terminated. The enrollment target is 2 participants. The study started on 2018-05-01. Estimated completion is 2018-11-30.

Who is sponsoring clinical trial NCT03318237?

This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT03318237, the US trial registry maintained by the National Library of Medicine. NCT03318237 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.