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CompletedNCT00001325Updated Mar 4, 2008

Metabolic Abnormalities in Children With Epilepsy

An observational study in Generalized Epilepsy, Infantile Spasms and Metabolic Disease, sponsored by National Institute of Neurological Disorders and Stroke (NINDS). Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2008-03-04.

Sponsored by National Institute of Neurological Disorders and Stroke (NINDS) · Observational

Study type
Observational
Enrollment
80
Sex
All
01

Study 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;

  1. Are changes in brain energy use (metabolism) present early in the course of epilepsy
  1. Do changes in brain metabolism match the severity of patient's seizures
  1. Do changes in metabolism occur over time or in response to drug therapy
Read the 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.

02

Conditions studied

  • 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
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In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 80 is below the median of 102 across 521 observational studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS) is the lead sponsor of 592 studies on the registry; 56 are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 8 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Patients with partial seizures, infantile spasms and Lennox-Gastaut syndrome will be selected.

Exclusion criteria

EXCLUSION CRITERIA:

Evidence of a structural lesion as cause for epilepsy.

Degenerative or metabolic disease.

Inability to comply with the protocol.

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Study design

Enrollment
80 participants

Interventions

  • Drug18 FDG
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Study locations

1 site
  • National Institute of Neurological Disorders and Stroke (NINDS)
    Bethesda, Maryland 20892, United States
07

References and documents

Publications

  • 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. PubMed 6416142 ↗
  • 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. PubMed 3501693 ↗
  • 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. PubMed 6818896 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00001325
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
First posted
Nov 4, 1999
Start date
Apr 1992
Completion
Jun 2004
Last update
Mar 4, 2008
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2004. You cannot join it, but the record below documents what was studied.

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