Metabolic Abnormalities in Children With Epilepsy

Metabolic Disease Clinical Trial

Official title:

Natural History of Metabolic Abnormalities in Children With Epilepsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001325
• Other study ID #: 920175
• Secondary ID: 92-N-0175
• Status: Completed
• Phase: N/A
• First received: November 3, 1999
• Last updated: March 3, 2008
• Start date: April 1992
• Est. completion date: June 2004

Study information

• Verified date: June 2004
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy
• Epilepsy, Generalized
• Generalized Epilepsy
• Infantile Spasms
• Metabolic Disease
• Metabolic Diseases
• Partial Epilepsy
• Seizures
• Spasms, Infantile

Intervention

Drug:
• 18 FDG

Locations

Country	Name	City	State
United States	National Institute of Neurological Disorders and Stroke (NINDS)	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

Chugani HT, Phelps ME, Mazziotta JC. Positron emission tomography study of human brain functional development. Ann Neurol. 1987 Oct;22(4):487-97. — View 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. — View Citation