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CompletedNCT00610558Updated Nov 20, 2019Results posted

Neocortical Epilepsies - Do They Progress?

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

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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.

Read the 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

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Conditions studied

  • Epilepsy

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03

In context

Epilepsy

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 →

Lead sponsor

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.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Arm 1: Juvenile Myoclonic Epilepsy

    Juvenile Myoclonic Epilepsy group of subjects will participate for imaging assessment

    Device: Arm 1: Juvenile Myoclonic Epilepsy

  • Experimental
    Arm 2: Frontal Lobe Epilepsy

    Frontal Lobe Epilepsy group of subjects will participate for imaging assessment

    Device: Arm 2: Frontal Lobe Epilepsy

  • Experimental
    Arm 3: Normal Controls

    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

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

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What researchers measure

Primary outcomes

  1. 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

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Results

Posted Nov 20, 2019

Participant flow

Participant flow — Overall Study
MilestoneArm 1: Juvenile Myoclonic EpilepsyArm 2: Frontal Lobe EpilepsyArm 3: Normal Cont
Started202020
Completed151414
Not completed566

Outcome measures

PrimaryFunctional 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

No measurements were reported for this outcome.

Adverse events

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.

Adverse event summary by group
GroupDeathsSeriousOther
Arm 1: Juvenile Myoclonic Epilepsy0/15 (0%)0/15 (0%)0/15 (0%)
Arm 2: Frontal Lobe Epilepsy0/14 (0%)0/14 (0%)0/14 (0%)
Arm 3: Normal Controls0/14 (0%)0/14 (0%)0/14 (0%)
Most frequent serious events
Most frequent serious events
EventArm 1: Juvenile Myoclonic EpilepsyArm 2: Frontal Lobe EpilepsyArm 3: Normal Controls
Allergic reactions to the contrastsGeneral disorders0/150/140/14
Most frequent other events
Most frequent other events
EventArm 1: Juvenile Myoclonic EpilepsyArm 2: Frontal Lobe EpilepsyArm 3: Normal Controls
Bleeding, soreness or swelling of injection siteGeneral disorders0/150/140/14

Baseline characteristics

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
Age, Categorical(Participants)Arm1: Juvenile Myoclonic EpilepsyArm 2: Frontal Lobe EpilepsyArm 3: Normal ControlsTotal
<=18 years0000
Between 18 and 65 years15141443
>=65 years0000
Age, Continuous
Age, Continuous(years)Arm1: Juvenile Myoclonic EpilepsyArm 2: Frontal Lobe EpilepsyArm 3: Normal ControlsTotal
Mean38 ± 6.537 ± 6.840 ± 7.738.3 ± 7.1
Sex: Female, Male
Sex: Female, Male(Participants)Arm1: Juvenile Myoclonic EpilepsyArm 2: Frontal Lobe EpilepsyArm 3: Normal ControlsTotal
Female88723
Male76720
Region of Enrollment
Region of Enrollment(Participants)Arm1: Juvenile Myoclonic EpilepsyArm 2: Frontal Lobe EpilepsyArm 3: Normal ControlsTotal
United States15141443
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Study locations

1 site
  • Center for Functional Onco-Imaging, University of California
    Irvine, California 92697, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00610558
Lead sponsor
University of California, Irvine
Responsible party
Min-Ying (Lydia) Su (Professor, University of California, Irvine) — Principal investigator
First posted
Feb 8, 2008
Start date
Jul 2003
Primary completion
Jun 2009
Completion
Sep 2010
Results posted
Nov 20, 2019
Last update
Nov 20, 2019

Study contacts

Min-Ying Su, PhD
principal investigator · University of California, Irvine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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