- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00393666
Why Are Patients With Absence Seizures Absent? A Brain Imaging Study
Functional Neuroimaging in Childhood Absence Epilepsy
Study Overview
Status
Conditions
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
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06510
- Yale University School of Medicine, Neurology Department
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Collaborators and Investigators
Sponsor
Collaborators
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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIH R01 NS055829
- HIC # 18514
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Childhood Absence Epilepsy
-
Assistance Publique - Hôpitaux de ParisCompletedChildhood Absence Epilepsy [Pyknolepsy]France
-
Fondation Ophtalmologique Adolphe de RothschildTerminatedChildhood or Juvenile Absence EpilepsyFrance
-
UCB Biopharma SRLRecruitingChildhood Absence Epilepsy | Juvenile Absence EpilepsyUnited States, Australia, Georgia, Italy, Poland, Romania, Slovakia, Spain, Ukraine, Belgium
-
UCB Biopharma SRLEnrolling by invitationChildhood Absence Epilepsy | Juvenile Absence EpilepsyUnited States, Georgia, Italy, Romania, Ukraine, Slovakia, Spain
-
UCB Biopharma SRLNot yet recruitingChildhood Absence Epilepsy | Juvenile Absence Epilepsy
-
University of British ColumbiaTerminatedJuvenile Myoclonic Epilepsy | Childhood Absence Epilepsy | Juvenile Absence EpilepsyCanada
-
Eysz, Inc.University of Colorado, Denver; Wake Forest University Health Sciences; Children...Not yet recruitingChildhood Absence Epilepsy | Absence Seizures | Epilepsy ComorbiditiesUnited States
-
Radius Pharmaceuticals, Inc.TerminatedChildhood Absence EpilepsyUnited States
-
Radius Pharmaceuticals, Inc.Benuvia Therapeutics Inc.TerminatedChildhood Absence EpilepsyUnited States
-
Johnson & Johnson Pharmaceutical Research & Development...Ortho-McNeil Neurologics, Inc.CompletedEpilepsy, Absence