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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00393666
Other study ID # NIH R01 NS055829
Secondary ID HIC # 18514
Status Completed
Phase N/A
First received October 23, 2006
Last updated January 25, 2016
Start date September 2006
Est. completion date September 2015

Study information

Verified date January 2016
Source Yale University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

Our study examines which different brain regions are involved in child absence seizures and how they are related to attention and cognition.


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


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Years to 18 Years
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Yale University School of Medicine, Neurology Department New Haven Connecticut

Sponsors (2)

Lead Sponsor Collaborator
Yale University National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

See also
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Completed NCT00361010 - A Pilot Study of Efficacy and Tolerability of Levetiracetam Monotherapy in Subjects With Childhood Absence Epilepsy N/A
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