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Why Are Patients With Absence Seizures Absent? A Brain Imaging Study
This study is currently recruiting participants.
Verified by Yale University, April 2009
First Received: October 23, 2006   Last Updated: April 20, 2009   History of Changes
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

Resource links provided by NLM:


Further study details as provided by Yale University:

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

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)
Detailed 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.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pediatric patients diagnosed with absence epilepsy

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00393666

Contacts
Contact: Hal Blumenfeld, MD, PhD 203-785-3928 hal.blumenfeld@yale.edu

Locations
United States, Connecticut
Yale University School of Medicine, Neurology Department Recruiting
New Haven, Connecticut, United States, 06510
Principal Investigator: Hal Blumenfeld, MD, PhD            
Sponsors and Collaborators
Yale University
Investigators
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

No publications provided

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

Keywords provided by Yale University:
Absence
Epilepsy
Seizure
Brain

Additional relevant MeSH terms:
Epilepsy
Nervous System Diseases
Epilepsy, Absence
Central Nervous System Diseases
Epilepsy, Generalized
Brain Diseases

ClinicalTrials.gov processed this record on November 27, 2009