Ultra High Field MRI of Focal Pediatric Epilepsy

Stopped early

Conditions studied: Epilepsy

In brief

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 with refractory epilepsy has fundamental management implications, as surgical removal of such lesion may dramatically improve outcomes and the chance of seizure freedom.

Key facts

Study ID

NCT03318237

Run by

Johns Hopkins University

People needed

2

Starts

2018-05-01

Expected to finish

2018-11-30

Last updated by the study team

2019-09-16

Who can join

Age: 6 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female children between 6-21 years of age undergoing an MRI for focal epilepsy at the Johns Hopkins Hospital OR ii. Adult healthy volunteer. iii. Willing to undergo an additional MRI exam in the 7T scanner at Kennedy Krieger Institute.

You may not qualify if…

• Presence of any contraindication to MR examinations as defined by MRI Safety Screening Sheet ii. History of Metal in the Skull/Eyes iii. Pregnancy at the time of the scan iv. Patient subjects in unstable clinical condition

Where it is running

• Johns Hopkins University — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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