Our study examines which different brain regions are involved in child absence seizures and how they are related to attention and cognition...
Date First Received: October 23, 2006
Last Updated: April 20, 2009
Verified by: Yale University, April 2009
Clinical Trial Phase: N/A | Start Date: September 2006
Overall Status: Recruiting
Estimated Enrollment: 180
Brief Summary
Official Title: “Functional Neuroimaging in Childhood Absence Epilepsy”
Condition Keyword(s):
Our study examines which different brain regions are involved in child absence seizures and how they are related to attention and cognition.
Study Type: Observational
Study Design: Case Control, Prospective
Study Primary Completion Date: September 2010
Detailed Clinical Trial Description
The fundamental mechanisms of altered brain function and impaired attention in childhood absence epilepsy (CAE) are not known. Absence seizures consist of brief 5-10 seconds episodes of unresponsiveness, associated with a 3-4 Hz "spike-wave" discharge on electroencephalogram (EEG). CAE affects 10-15% of children with epilepsy. In addition to the deficit during seizures, many children also suffer from milder attention impairment between absence episodes, which may not be due entirely to medications. Impaired attention during and between absence seizures has a major negative impact on patient quality of life due to deficits in school performance, potential for injuries, and social stigma.
Recent studies suggest that impaired cognition in so-called "generalized" absence seizures may, in fact, depend on dysfunction in specific brain networks. Our central hypothesis is:
abnormal function in focal brain regions, such as the anterior cingulate/medial prefrontal cortex and medial thalamus, causes impaired attention both during and between seizures in CAE. If confirmed, this may lead to innovative regional therapies targeted at improving impaired attention in CAE. Specifically, we hope to determine which specific cortical and sub-cortical networks are selectively involved when patients show impaired attention. Using simultaneous EEG and functional magnetic resonance imaging (fMRI), we will determine which brain regions are involved in absence seizures while using a continuous performance task (CPT) to test attention vigilance in the same patients. A few neuropsychology tests will then follow. Patients will be reimbursed $100 as well as all travel and parking expenses.
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Confirmed diagnosis of childhood absence epilepsy or juvenile absence epilepsy
- No other serious health problems or neurological problems
- Between 6 and 18 years of age
Exclusion Criteria:
- No history of myoclonic or tonic-clonic seizures
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 6 Years
Maximum Age for this Clinical Trial: 18 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: Yale University
Overall Clinical Trial Officials and Contacts
Hal Blumenfeld, MD, PhD Principal Investigator Yale University
Overall Contact: Hal Blumenfeld, MD, PhD 203-785-3928 hal.blumenfeld@yale.edu
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00393666
Study ID Number: NIH R01 NS055829
ClinicalTrials.gov Identifier: NCT00393666
Health Authority: United States: Institutional Review Board
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