An interventional study of Arm 1: Juvenile Myoclonic Epilepsy and Arm 2: Frontal Lobe Epilepsy in Epilepsy, sponsored by University of California, Irvine. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-20.
Sponsored by University of California, Irvine · Not applicable, Interventional, and Diagnostic
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
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's enrollment of 60 is above the median of 50 across 1,205 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →University of California, Irvine is the lead sponsor of 466 studies on the registry; 96 are open to participants now.
Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Juvenile Myoclonic Epilepsy group of subjects will participate for imaging assessment
Device: Arm 1: Juvenile Myoclonic Epilepsy
Frontal Lobe Epilepsy group of subjects will participate for imaging assessment
Device: Arm 2: Frontal Lobe Epilepsy
Normal Controls, eligible subjects don't have Juvenile Myoclonic Epilepsy or Frontal Lobe Epilepsy will be placed in this group
Device: Arm 3: Normal Controls
Positron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI
Positron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI
Positron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI
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
| Milestone | Arm 1: Juvenile Myoclonic Epilepsy | Arm 2: Frontal Lobe Epilepsy | Arm 3: Normal Cont |
|---|---|---|---|
| Started | 20 | 20 | 20 |
| Completed | 15 | 14 | 14 |
| Not completed | 5 | 6 | 6 |
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.
No measurements were reported for this outcome.
Collected over Subjects monitored for safety events during the entire imaging session; up to 1 hour. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1: Juvenile Myoclonic Epilepsy | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Arm 2: Frontal Lobe Epilepsy | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Arm 3: Normal Controls | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Event | Arm 1: Juvenile Myoclonic Epilepsy | Arm 2: Frontal Lobe Epilepsy | Arm 3: Normal Controls |
|---|---|---|---|
| Allergic reactions to the contrastsGeneral disorders | 0/15 | 0/14 | 0/14 |
| Event | Arm 1: Juvenile Myoclonic Epilepsy | Arm 2: Frontal Lobe Epilepsy | Arm 3: Normal Controls |
|---|---|---|---|
| Bleeding, soreness or swelling of injection siteGeneral disorders | 0/15 | 0/14 | 0/14 |
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,
| Age, Categorical(Participants) | Arm1: Juvenile Myoclonic Epilepsy | Arm 2: Frontal Lobe Epilepsy | Arm 3: Normal Controls | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 15 | 14 | 14 | 43 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Arm1: Juvenile Myoclonic Epilepsy | Arm 2: Frontal Lobe Epilepsy | Arm 3: Normal Controls | Total |
|---|---|---|---|---|
| Mean | 38 ± 6.5 | 37 ± 6.8 | 40 ± 7.7 | 38.3 ± 7.1 |
| Sex: Female, Male(Participants) | Arm1: Juvenile Myoclonic Epilepsy | Arm 2: Frontal Lobe Epilepsy | Arm 3: Normal Controls | Total |
|---|---|---|---|---|
| Female | 8 | 8 | 7 | 23 |
| Male | 7 | 6 | 7 | 20 |
| Region of Enrollment(Participants) | Arm1: Juvenile Myoclonic Epilepsy | Arm 2: Frontal Lobe Epilepsy | Arm 3: Normal Controls | Total |
|---|---|---|---|---|
| United States | 15 | 14 | 14 | 43 |
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of California, Irvine