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| Sponsor: | Yale University |
|---|---|
| Collaborator: |
National Institutes of Health (NIH) |
| Information provided by: | Yale University |
| ClinicalTrials.gov Identifier: | NCT00393666 |
Purpose
Our study examines which different brain regions are involved in child absence seizures and how they are related to attention and cognition.
| Condition |
|---|
|
Childhood Absence Epilepsy |
| Study Type: | Observational |
| Study Design: | Case Control, Prospective |
| Official Title: | Functional Neuroimaging in Childhood Absence Epilepsy |
Saliva samples
| Estimated Enrollment: | 180 |
| Study Start Date: | September 2006 |
| Estimated Study Completion Date: | September 2010 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 6 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Pediatric patients diagnosed with absence epilepsy
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Hal Blumenfeld, MD, PhD | 203-785-3928 | hal.blumenfeld@yale.edu |
| United States, Connecticut | |
| Yale University School of Medicine, Neurology Department | Recruiting |
| New Haven, Connecticut, United States, 06510 | |
| Principal Investigator: Hal Blumenfeld, MD, PhD | |
| Principal Investigator: | Hal Blumenfeld, MD, PhD | Yale University |
| Study Director: | Michiro Negishi, PhD | Diagnostic Radiology |
| Study Chair: | Edward Novotny, MD | Yale University |
| Study Director: | Marisa Spann, PhD | Yale University |
| Study Director: | R. Todd Constable, PhD | Yale University |
More Information
| Responsible Party: | Yale School of Medicine ( Hal Blumenfeld, MD, PhD/ Associate Professor ) |
| Study ID Numbers: | NIH R01 NS055829, HIC # 18514 |
| Study First Received: | October 23, 2006 |
| Last Updated: | April 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00393666 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Absence Epilepsy Seizure Brain |
|
Epilepsy Nervous System Diseases Epilepsy, Absence |
Central Nervous System Diseases Epilepsy, Generalized Brain Diseases |