NCT03318237

Ultra High Field MRI of Focal Pediatric Epilepsy

Terminated Last updated 16 September 2019

What this trial tests

trial in Epilepsy in 2 participants. Terminated before completion.

Timeline

1 May 2018

Primary endpoint
30 November 2018

30 November 2018

Quick facts

Lead sponsor	Johns Hopkins University
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	2
Start date	1 May 2018
Primary completion	30 November 2018
Estimated completion	30 November 2018
Sites	1 location across United States

Conditions studied

• Epilepsy — all drugs for Epilepsy →

Sponsor

Johns Hopkins University

Who can join

Adults 6 to 21, any sex, with Epilepsy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.