Clinical Trial: Imaging the Effect of Centrotemporal Spikes and Seizures on Language in Children
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Imaging the Effect of Centrotemporal Spikes and Seizures on Language in Children
Brief Summary: This project examines how seizures, and abnormal brain activity, affect language skill in children with Benign Childhood Epilepsy with Centro-Temporal Spikes (BECTS). BECTS is a common type of childhood epilepsy, and while BECTS patients stop having seizures by their late teenage years, many studies have shown that these children have language problems that may lead to academic and social difficulties. Using standardized language testing, monitoring of brain activity, and MRI brain imaging, this project aims to determine what particular combination of BECTS symptoms put children most at risk for language problems and whether treatment with anti-epileptic medications may be helpful.
Detailed Summary:
Benign Childhood Epilepsy with Centro-Temporal Spikes (BECTS), an extremely common type of childhood epilepsy, is traditionally assumed to have a benign course, but recent studies have shown that cognitive function, especially language, is often impaired in BECTS patients. However, it is not clear whether ithe seizures, the centrotemporal spikes (CTS), or other factors cause the negative cognitive consequences that may impact school performance and social interaction. BECTS patients have scattered seizures but very frequent CTS, and may be suffering with undiagnosed cognitive and language deficits. This suggests a causal role for CTS that has not yet been investigated in detail. This project will examine the impact of seizures and CTS on neurocognitive function in BECTS patients, at diagnosis and after one year. We will gather critical information regarding the effect of the anti-epileptic medication levetiracetam on CTS, which will inform a future Phase III clinical trial aimed at eliminating CTS and improving long term outcome.
This study will explore the interactions between CTS, seizures and neuropsychological outcomes using Functional MRI of language in order to decipher changes in neural circuitry that underlie language deficits found in children with BECTS. Using standardized neuropsychological testing and fMRI at the time of diagnosis, this study will first characterize the nature and incidence of language problems in children with BECTS, separating the effects of CTS and seizures. It is expected that children with BECTS will perform below normative standards on tests of language skill, accompanied by aberrations in the neural circuitry supporting language processing as tested with fMRI. These data will also make it possible to characterize which children with BECTS are most at risk for language problems, by taking into account contributing factors such as number
Sponsor: Children's Hospital Medical Center, Cincinnati
Current Primary Outcome: Number of Centrotemporal Spikes per minute on EEG [ Time Frame: 52 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Composite Score on CELF-4 Core Subtests (Language) [ Time Frame: 52 Weeks ]
- fMRI Lateralization indices for three language tasks [ Time Frame: 52 Weeks ]
Original Secondary Outcome: Same as current
Information By: Children's Hospital Medical Center, Cincinnati
Dates:
Date Received: January 26, 2012
Date Started: January 2012
Date Completion: June 2017
Last Updated: February 17, 2017
Last Verified: February 2017
