Neocortical Epilepsies - Do They Progress?
This study has been completed.
Sponsor:
University of California, Irvine
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00610558
First received: January 12, 2008
Last updated: August 2, 2011
Last verified: August 2011
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Purpose
This study will use MRI and PET scan to compare the brain imaging results between epilepsy patients and normal healthy controls, also to study changes in 3 years.
| Condition | Intervention |
|---|---|
|
Epilepsy |
Device: positron emission tomography (PET) |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Neocortical Epilepsies - Do They Progress? |
Resource links provided by NLM:
Genetics Home Reference related topics:
pyridoxal 5'-phosphate-dependent epilepsy
MedlinePlus related topics:
Epilepsy
U.S. FDA Resources
Further study details as provided by University of California, Irvine:
Primary Outcome Measures:
- We hope to provide evidence that temporal lobe epilepsy is not the only syndrome which suffers from progressive memory loss, volume loss, hypometabolism and loss of seizure control. [ Time Frame: at completion of the study ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- We hope to be able to reassure subjects with primary generalized epilepsy (JME) that while they may have some isolated difficulties with certain tasks, they do not have a progressive disorder. [ Time Frame: at completion of study ] [ Designated as safety issue: No ]
| Enrollment: | 43 |
| Study Start Date: | July 2003 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Device: positron emission tomography (PET)
FDG-glucose (10 mCi)
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Controls (20 Subjects):
Inclusion criteria:
- Ages 18-65, based on the usual ages of patients seen in the adult neurology services who are not likely to suffer from the exclusions (see below).
Exclusion criteria:
- History of seizures, faints, or any unexplained blackouts.
- Use of neuroleptic medications or sedating doses of antianxiety or antidepressant drugs.
- They should not have a clear family history of epilepsy (first degree relatives).
- History of any substance abuse within the past 5 years.
- History of progressive medical or neurologic disease (Parkinson's, severe congestive heart failure). Controlled hypertension, diabetes (by oral medications or diet), asthma, etc will not be excluded.
- History of stroke without complete recovery of neurologic function.
- Pregnancy
- With any metallic implants, including surgical clips (hemostatic clips), pacemakers, neuro-stimulation devices, prosthetic heart valves, or other ferromagnetic material.
- Inability to understand the consent. (standard form attached)
- Inability to speak fluent English. Note: the neuropsychological tests are standardized for English speakers. They are not all available in multiple languages. Since the scoring and norms are established for English speakers, simply translating them would still not make the testing norms and scoring applicable.
Juvenile Myoclonic Epilepsy (JME; 20 Subjects):
Inclusion Criteria:
- Ages 18-65, based on the usual ages of patients seen in the adult neurology services who are not likely to suffer from the exclusions (see below), plus
- History of myoclonic plus tonic-clonic or clonic-tonic-clonic seizures with or without absence seizures.
- EEG consistent with primary generalized epilepsy (>/= 3 c/s generalized, frontal maximum, poly spike and wave; normal alpha)
Exclusion Criteria
- History of significant head injury (> 30 min loss of consciousness)
- Use of neuroleptic drugs or sedative doses of antianxiety or antidepressant drugs
- History of any substance abuse within the past 5 years
- Presence of epileptogenic brain lesion on MRI (tumor, stroke, cortical congenital dysplasia, etc; excluding normal variants, mild subcortical white matter ischemic change, venous angiomas).
- EEG with focal epileptiform potentials or polymorphic slowing
- History of progressive medical or neurologic disease (Parkinson's, severe congestive heart failure). Controlled hypertension, diabetes (by oral medications or diet), asthma, etc will not be excluded.
- History of stroke without complete recovery of neurologic function.
- Pregnancy
- With any metallic implants, including surgical clips (hemostatic clips), pacemakers, neuro-stimulation devices, prosthetic heart valves, or other ferromagnetic material.
- Inability to speak fluent English
Frontal Lobe Epilepsy (FLE; 20 Subjects):
Inclusion Criteria
- Ages 18-65, based on the usual ages of patients seen in the adult neurology services who are not likely to suffer from the exclusions (see below), plus:
- Seizure semiology (behavior) consistent with FLE
- Interictal EEG spikes consistent with FLE or
- Ictal video-EEG consistent with FLE
- Frontal lobe lesion of MRI
- Frontal hypometabolism on FDG-PET
Exclusion Criteria:
- Presence of seizure semiology, ictal EEG, interictal EEG, MRI or PET findings that are not consistent with a frontal lobe epilepsy focus.
- Use of neuroleptic drugs or sedative doses of antianxiety or antidepressant drugs
- History of any substance abuse within the past 5 years
- History of progressive medical or neurologic disease (Parkinson's, severe congestive heart failure). Controlled hypertension, diabetes (by oral medications or diet), asthma, etc will not be excluded.
- History of stroke without complete recovery of neurologic function.
- Pregnancy
- With any metallic implants, including surgical clips (hemostatic clips), pacemakers, neuro-stimulation devices, prosthetic heart valves, or other ferromagnetic material.
- Absence of either a radial or ulnar arterial pulse
- Inability to speak fluent English
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00610558
Locations
| United States, California | |
| Center for Functional Onco-Imaging, University of California | |
| Irvine, California, United States, 92697 | |
Sponsors and Collaborators
University of California, Irvine
Investigators
| Principal Investigator: | Min-Ying Su, PhD | University of California, Irvine |
More Information
No publications provided
| Responsible Party: | Min-Ying Su, Associate Professor, University of California, Irvine |
| ClinicalTrials.gov Identifier: | NCT00610558 History of Changes |
| Other Study ID Numbers: | UCI-HS-2003-3252, VA-821/103 |
| Study First Received: | January 12, 2008 |
| Last Updated: | August 2, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013