Why Are Patients With Absence Seizures Absent? A Brain Imaging Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Yale University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Hal Blumenfeld, Yale University
ClinicalTrials.gov Identifier:
NCT00393666
First received: October 23, 2006
Last updated: June 10, 2013
Last verified: June 2013
  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: Observational Model: Case Control
Time Perspective: 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

Saliva samples


Estimated Enrollment: 180
Study Start Date: September 2006
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (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.

For more information, please visit www.yalecae.com

  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
  • 6 years or older

Exclusion Criteria:

  • No history of myoclonic or tonic-clonic seizures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Hal Blumenfeld, MD, PhD 203-815-7231 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 Director: R. Todd Constable, PhD Yale University
Study Director: Jennifer Guo, MS Yale University
  More Information

No publications provided

Responsible Party: Hal Blumenfeld, Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT00393666     History of Changes
Other Study ID Numbers: NIH R01 NS055829, HIC # 18514
Study First Received: October 23, 2006
Last Updated: June 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Absence
Epilepsy
Seizure
Brain

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

ClinicalTrials.gov processed this record on September 18, 2014