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Ultra High Field MRI of Focal Pediatric Epilepsy

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ClinicalTrials.gov Identifier: NCT03318237
Recruitment Status : Terminated (PI moved to a different institution.)
First Posted : October 23, 2017
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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


Condition or disease
Epilepsy

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 2 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Ultra High Field MRI of Focal Pediatric Epilepsy
Actual Study Start Date : May 1, 2018
Actual Primary Completion Date : November 30, 2018
Actual Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Group/Cohort
Patients with focal epilepsy
Patients undergoing ultra high field MRI of the brain



Primary Outcome Measures :
  1. Detection rate of subtle structural epileptogenic abnormalities in children with focal epilepsy. [ Time Frame: At the time of brain MRI exam. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Children with the diagnosis of epilepsy and findings on EEG suggestive of a focal structural abnormality.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03318237


Locations
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United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03318237     History of Changes
Other Study ID Numbers: IRB00125321
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases