Neocortical Epilepsies - Do They Progress?

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Device: Arm 1: Juvenile Myoclonic Epilepsy; Device: Arm 2: Frontal Lobe Epilepsy; Device: Arm 3: Normal Controls

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Juvenile Myoclonic Epilepsy; Juvenile Myoclonic Epilepsy group of subjects will participate for imaging assessment	Device: Arm 1: Juvenile Myoclonic Epilepsy; Positron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI
Experimental: Arm 2: Frontal Lobe Epilepsy; Frontal Lobe Epilepsy group of subjects will participate for imaging assessment	Device: Arm 2: Frontal Lobe Epilepsy; Positron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI
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; Positron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Investigators: Principal Investigator: Min-Ying Su, PhD, University of California, Irvine

Study record dates

Study Major Dates

• Study Start: July 1, 2003
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: January 12, 2008
• First Submitted That Met QC Criteria: January 25, 2008
• First Posted (Estimate): February 8, 2008

Study Record Updates

• Last Update Posted (Actual): November 20, 2019
• Last Update Submitted That Met QC Criteria: November 1, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: UCI-HS-2003-3252; VA-821/103 (Other Identifier: VAMC West Los Angeles)