Generalized EpilepsyNCT00001325
Metabolic Abnormalities in Children With Epilepsy
An observational study of Generalized Epilepsy and Infantile Spasms, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Generalized Epilepsy, Infantile Spasms, Metabolic Disease
- What is being tested?
- 18 FDG
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1992to Jun 2004
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with partial seizures, infantile spasms and Lennox-Gastaut syndrome will be selected.
Who cannot join
- Evidence of a structural lesion as cause for epilepsy.
- Degenerative or metabolic disease.
- Inability to comply with the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: Natural History of Metabolic Abnormalities in Children With Epilepsy
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.
Read more
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;
- Are changes in brain energy use (metabolism) present early in the course of epilepsy
- Do changes in brain metabolism match the severity of patient's seizures
- 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.
- Being tested
- 18 FDG
- Keywords
- Positron, Tomography, Seizures, Epileptic Focus, Electroencephalography, Metabolism, Glucose, Cerebral, Positron Emission Tomography, Lennox Gastaut Syndrome
- Medical subject headings
- Epilepsy, Generalized, Spasms, Infantile, Metabolic Diseases, Epilepsies, Partial, Seizures, Lennox Gastaut Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18 FDGDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startApr 1992
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Generalized EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001325
- Sponsor's protocol ID
- 920175
- Other IDs
- 92-N-0175
- Status last verified
- Jun 2004
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
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 6416142Chugani 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 3501693Engel 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History of Metabolic Abnormalities in Children With Epilepsy
- ClinicalTrials.gov ID
- NCT00001325
- Acronym / sponsor ID
- 920175
- Keywords
- Positron, Tomography, Seizures, Epileptic Focus, Electroencephalography, Metabolism, Glucose, Cerebral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Apr 1992
- Study completion
- Jun 2004
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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;
- Are changes in brain energy use (metabolism) present early in the course of epilepsy
- Do changes in brain metabolism match the severity of patient's seizures
- 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.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with partial seizures, infantile spasms and Lennox-Gastaut syndrome will be selected.
Key exclusion criteria (3 listed)
- Evidence of a structural lesion as cause for epilepsy.
- Degenerative or metabolic disease.
- Inability to comply with the protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18 FDG | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 6416142Bourgeois 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.
- Background: PubMed 3501693Chugani 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.
- Background: PubMed 6818896Engel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Generalized Epilepsy and Infantile Spasms, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001325, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.