Epilepsy
Conditions
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
Interventions
DEVICEArm 1: Juvenile Myoclonic Epilepsy
Positron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI
DEVICEArm 2: Frontal Lobe Epilepsy
Positron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI
DEVICEArm 3: Normal Controls
Positron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI
Sponsors
University of California, Irvine
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Three different Groups in this study: Juvenile Myoclonic Epilepsy, Frontal Lobe Epilepsy, Normal Controls
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Connectivity | During Imaging Session | 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. |
Countries
United States
Participant flow
Pre-assignment details
There is no pre-assignment for this study
Participants by arm
| Arm | Count |
|---|---|
| Arm1: Juvenile Myoclonic Epilepsy Subject will are eligible for this group will participate the MRI imaging | 15 |
| Arm 2: Frontal Lobe Epilepsy Subject will are eligible for this group will participate the MRI imaging | 14 |
| Arm 3: Normal Controls Subject will are eligible for this group will participate the MRI imaging | 14 |
| Total | 43 |
Baseline characteristics
| Characteristic | Arm 2: Frontal Lobe Epilepsy | Arm 3: Normal Controls | Arm1: Juvenile Myoclonic Epilepsy | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 14 Participants | 15 Participants | 43 Participants |
| Age, Continuous | 37 years STANDARD_DEVIATION 6.8 | 40 years STANDARD_DEVIATION 7.7 | 38 years STANDARD_DEVIATION 6.5 | 38.3 years STANDARD_DEVIATION 7.1 |
| Region of Enrollment United States | 14 Participants | 14 Participants | 15 Participants | 43 Participants |
| Sex: Female, Male Female | 8 Participants | 7 Participants | 8 Participants | 23 Participants |
| Sex: Female, Male Male | 6 Participants | 7 Participants | 7 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 0 / 15 | 0 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 15 | 0 / 14 | 0 / 14 |
Outcome results
Primary
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.
Time frame: During Imaging Session
Population: This protocol has been closed about 10 years ago. All files have been destroyed per IRB requirement.