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

NCT ID: NCT00393666

Last Updated: 2016-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-09-30

Study Completion Date

2015-09-30

Brief Summary

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

Detailed Description

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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

Conditions

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Childhood Absence Epilepsy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Hal Blumenfeld

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hal Blumenfeld, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Michiro Negishi, PhD

Role: STUDY_DIRECTOR

Diagnostic Radiology

R. Todd Constable, PhD

Role: STUDY_DIRECTOR

Yale University

Jennifer Guo, MS

Role: STUDY_DIRECTOR

Yale University

Locations

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Yale University School of Medicine, Neurology Department

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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HIC # 18514

Identifier Type: -

Identifier Source: secondary_id

NIH R01 NS055829

Identifier Type: -

Identifier Source: org_study_id

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