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| ID | Type | Description | Link |
|---|---|---|---|
| VA-821/103 | Other Identifier | VAMC West Los Angeles |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Juvenile Myoclonic Epilepsy | Experimental | Juvenile Myoclonic Epilepsy group of subjects will participate for imaging assessment |
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| Arm 2: Frontal Lobe Epilepsy | Experimental | Frontal Lobe Epilepsy group of subjects will participate for imaging assessment |
|
| Arm 3: Normal Controls | Experimental | Normal Controls, eligible subjects don't have Juvenile Myoclonic Epilepsy or Frontal Lobe Epilepsy will be placed in this group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arm 1: Juvenile Myoclonic Epilepsy | Device | Positron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During Imaging Session |
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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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| Name | Affiliation | Role |
|---|---|---|
| Min-Ying Su, PhD | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Functional Onco-Imaging, University of California | Irvine | California | 92697 | United States |
There is no pre-assignment for this study
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: Juvenile Myoclonic Epilepsy | Subjects who are eligible for this group will participate MRI imaging |
| FG001 | Arm 2: Frontal Lobe Epilepsy | Subjects who are eligible for this group will participate MRI imaging |
| FG002 | Arm 3: Normal Cont | Subjects who are eligible for this group will participate MRI imaging |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The imaging data of Arm 3 will be the baseline to compare the difference to the imaging data in Arm 1 and Arm 2. We used an MRI-based with high angular resolution imaging examination of adult human brains. We compared the connectivity patterns in control subjects versus patients with Juvenile Myoclonic Epilepsy or Frontal Lobe Epilepsy,
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm1: Juvenile Myoclonic Epilepsy | Subject will are eligible for this group will participate the MRI imaging |
| BG001 | Arm 2: Frontal Lobe Epilepsy | Subject will are eligible for this group will participate the MRI imaging |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | This protocol has been closed about 10 years ago. All files have been destroyed per IRB requirement. | Posted | During Imaging Session |
|
Subjects monitored for safety events during the entire imaging session; up to 1 hour
All-Cause Mortality, Serious, and non-serious Adverse Events were monitored/assessed, but none observed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: Juvenile Myoclonic Epilepsy | 15 Subjects were monitored/assessed, but none observed |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reactions to the contrasts | General disorders | Systematic Assessment | Allergic reactions to the radiopharmaceutical may occur, but are extremely rare. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding, soreness or swelling of injection site | General disorders | Systematic Assessment | Bleeding, soreness or swelling may develop at injection site. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lydia Su | University of California, Irvine | (949) 824-4925 | msu@uci.edu |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Three different Groups in this study: Juvenile Myoclonic Epilepsy, Frontal Lobe Epilepsy, Normal Controls
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| Arm 2: Frontal Lobe Epilepsy | Device | Positron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI |
|
| Arm 3: Normal Controls | Device | Positron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI |
|
| BG002 | Arm 3: Normal Controls | Subject will are eligible for this group will participate the MRI imaging |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| OG001 |
| Arm 2: Frontal Lobe Epilepsy |
Subjects who are eligible to Frontal Lobe Epilepsy will participate the imaging study |
| OG002 | Arm 3: Normal Controls | Subjects who are eligible to the control group will participate the imaging study |
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Arm 2: Frontal Lobe Epilepsy | 14 Subjects were monitored/assessed, but none observed | 0 | 14 | 0 | 14 | 0 | 14 |
| EG002 | Arm 3: Normal Controls | 14 Subjects were monitored/assessed, but none observed | 0 | 14 | 0 | 14 | 0 | 14 |
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