Metabolic Abnormalities in Children With Epilepsy
Primary Purpose
Generalized Epilepsy, Infantile Spasms, Metabolic Disease
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
18 FDG
Sponsored by
About this trial
This is an observational trial for Generalized Epilepsy focused on measuring Positron, Tomography, Seizures, Epileptic Focus, Electroencephalography, Metabolism, Glucose, Cerebral, Positron Emission Tomography, Lennox Gastaut Syndrome
Eligibility Criteria
INCLUSION CRITERIA: Patients with partial seizures, infantile spasms and Lennox-Gastaut syndrome will be selected. EXCLUSION CRITERIA: Evidence of a structural lesion as cause for epilepsy. Degenerative or metabolic disease. Inability to comply with the protocol.
Sites / Locations
- National Institute of Neurological Disorders and Stroke (NINDS)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00001325
First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
1. Study Identification
Unique Protocol Identification Number
NCT00001325
Brief Title
Metabolic Abnormalities in Children With Epilepsy
Official Title
Natural History of Metabolic Abnormalities in Children With Epilepsy
Study Type
Observational
2. Study Status
Record Verification Date
June 2004
Overall Recruitment Status
Completed
Study Start Date
April 1992 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
4. Oversight
5. Study Description
Brief Summary
This study is designed to use positron emission tomography to measure brain energy use. Positron Emission Tomography (PET) is a technique used to investigate the functional activity of the brain. The PET technique allows doctors to study the normal processes of the brain (central nervous system) of normal individuals and patients with neurologic illnesses without physical / structural damage to the brain.
When a region of the brain is active, it uses more fuel in the form of oxygen and sugar (glucose). As the brain uses more fuel it produces more waste products, carbon dioxide and water. Blood carries fuel to the brain and waste products away from the brain. As brain activity increases blood flow to and from the area of activity increases also.
Researchers can label a sugar with a small radioactive molecule called FDG (fluorodeoxyglucose). As areas of the brain use more sugar the PET scan will detect the FDG and show the areas of the brain that are active. By using this technique researchers hope to answer the following questions;
4. Are changes in brain energy use (metabolism) present early in the course of epilepsy
5. Do changes in brain metabolism match the severity of patient's seizures
6. Do changes in metabolism occur over time or in response to drug therapy
Detailed Description
We propose to study children with recent onset partial epilepsy, cryptogenic infantile spasms, and idiopathic Lennox-Gastaut Syndrome with serial FDG-PET to elucidate the natural history and evolution of metabolic abnormalities associated with such epilepsies. The severity of the seizure disorder, and cognitive impairment, when present, will be correlated with the presence and extent of focal and global cerebral metabolic abnormalities.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Epilepsy, Infantile Spasms, Metabolic Disease, Partial Epilepsy, Seizures
Keywords
Positron, Tomography, Seizures, Epileptic Focus, Electroencephalography, Metabolism, Glucose, Cerebral, Positron Emission Tomography, Lennox Gastaut Syndrome
7. Study Design
Enrollment
80 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
18 FDG
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA:
Patients with partial seizures, infantile spasms and Lennox-Gastaut syndrome will be selected.
EXCLUSION CRITERIA:
Evidence of a structural lesion as cause for epilepsy.
Degenerative or metabolic disease.
Inability to comply with the protocol.
Facility Information:
Facility Name
National Institute of Neurological Disorders and Stroke (NINDS)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
6416142
Citation
Bourgeois BF, Prensky AL, Palkes HS, Talent BK, Busch SG. Intelligence in epilepsy: a prospective study in children. Ann Neurol. 1983 Oct;14(4):438-44. doi: 10.1002/ana.410140407.
Results Reference
background
PubMed Identifier
3501693
Citation
Chugani HT, Phelps ME, Mazziotta JC. Positron emission tomography study of human brain functional development. Ann Neurol. 1987 Oct;22(4):487-97. doi: 10.1002/ana.410220408.
Results Reference
background
PubMed Identifier
6818896
Citation
Engel J Jr, Kuhl DE, Phelps ME, Mazziotta JC. Interictal cerebral glucose metabolism in partial epilepsy and its relation to EEG changes. Ann Neurol. 1982 Dec;12(6):510-7. doi: 10.1002/ana.410120603.
Results Reference
background
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Metabolic Abnormalities in Children With Epilepsy
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