Neocortical Epilepsies - Do They Progress?
Primary Purpose
Epilepsy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Arm 1: Juvenile Myoclonic Epilepsy
Arm 2: Frontal Lobe Epilepsy
Arm 3: Normal Controls
Sponsored by
About this trial
This is an interventional diagnostic trial for Epilepsy
Eligibility 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
Sites / Locations
- Center for Functional Onco-Imaging, University of California
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Arm 1: Juvenile Myoclonic Epilepsy
Arm 2: Frontal Lobe Epilepsy
Arm 3: Normal Controls
Arm Description
Juvenile Myoclonic Epilepsy group of subjects will participate for imaging assessment
Frontal Lobe Epilepsy group of subjects will participate for imaging assessment
Normal Controls, eligible subjects don't have Juvenile Myoclonic Epilepsy or Frontal Lobe Epilepsy will be placed in this group
Outcomes
Primary Outcome Measures
Functional Connectivity
We will analyze the structural and metabolic differences between two epilepsy groups (JME and FLE) and understand the imaging presentations of epilepsy patients. We will process imaging requisition for Arm 1 and Arm 2 patients and the controls to examine if any differences in their brain image. The hypothesis is the functional connectivity between brainstem structures and cortical/subcortical regions may reflect in their imaging data. We would like to know if these imaging factors are related to epilepsy (JME and FLE) patients.
Secondary Outcome Measures
Full Information
NCT ID
NCT00610558
First Posted
January 12, 2008
Last Updated
November 1, 2019
Sponsor
University of California, Irvine
1. Study Identification
Unique Protocol Identification Number
NCT00610558
Brief Title
Neocortical Epilepsies - Do They Progress?
Official Title
Neocortical Epilepsies - Do They Progress?
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
We would like to continue analyzing the structural and metabolic differences between two epilepsy groups (JME and FLE) and the control to understand the imaging presentations of epilepsy patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Three different Groups in this study: Juvenile Myoclonic Epilepsy, Frontal Lobe Epilepsy, Normal Controls
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: Juvenile Myoclonic Epilepsy
Arm Type
Experimental
Arm Description
Juvenile Myoclonic Epilepsy group of subjects will participate for imaging assessment
Arm Title
Arm 2: Frontal Lobe Epilepsy
Arm Type
Experimental
Arm Description
Frontal Lobe Epilepsy group of subjects will participate for imaging assessment
Arm Title
Arm 3: Normal Controls
Arm Type
Experimental
Arm Description
Normal Controls, eligible subjects don't have Juvenile Myoclonic Epilepsy or Frontal Lobe Epilepsy will be placed in this group
Intervention Type
Device
Intervention Name(s)
Arm 1: Juvenile Myoclonic Epilepsy
Intervention Description
Positron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI
Intervention Type
Device
Intervention Name(s)
Arm 2: Frontal Lobe Epilepsy
Intervention Description
Positron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI
Intervention Type
Device
Intervention Name(s)
Arm 3: Normal Controls
Intervention Description
Positron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI
Primary Outcome Measure Information:
Title
Functional Connectivity
Description
We will analyze the structural and metabolic differences between two epilepsy groups (JME and FLE) and understand the imaging presentations of epilepsy patients. We will process imaging requisition for Arm 1 and Arm 2 patients and the controls to examine if any differences in their brain image. The hypothesis is the functional connectivity between brainstem structures and cortical/subcortical regions may reflect in their imaging data. We would like to know if these imaging factors are related to epilepsy (JME and FLE) patients.
Time Frame
During Imaging Session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min-Ying Su, PhD
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Functional Onco-Imaging, University of California
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
12. IPD Sharing Statement
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Neocortical Epilepsies - Do They Progress?
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