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
| Tracking Information | |||||
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| First Received Date ICMJE | January 12, 2008 | ||||
| Last Updated Date | August 2, 2011 | ||||
| Start Date ICMJE | July 2003 | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00610558 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Neocortical Epilepsies - Do They Progress? | ||||
| Official Title ICMJE | Neocortical Epilepsies - Do They Progress? | ||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Epilepsy | ||||
| Intervention ICMJE | Device: positron emission tomography (PET)
FDG-glucose (10 mCi) |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 43 | ||||
| Completion Date | September 2010 | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Controls (20 Subjects): Inclusion criteria:
Exclusion criteria:
Juvenile Myoclonic Epilepsy (JME; 20 Subjects): Inclusion Criteria:
Exclusion Criteria
Frontal Lobe Epilepsy (FLE; 20 Subjects): Inclusion Criteria
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00610558 | ||||
| Other Study ID Numbers ICMJE | UCI-HS-2003-3252, VA-821/103 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Min-Ying Su, Associate Professor, University of California, Irvine | ||||
| Study Sponsor ICMJE | University of California, Irvine | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of California, Irvine | ||||
| Verification Date | August 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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