Neocortical Epilepsies - Do They Progress?

NCT ID: NCT00610558

Last Updated: 2019-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-07-31
• Study Completion Date: 2010-09-30

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

Conditions

Epilepsy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Arm 1: Juvenile Myoclonic Epilepsy

Juvenile Myoclonic Epilepsy group of subjects will participate for imaging assessment

Group Type: EXPERIMENTAL

Arm 1: Juvenile Myoclonic Epilepsy

Intervention Type: DEVICE

Positron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI

Arm 2: Frontal Lobe Epilepsy

Frontal Lobe Epilepsy group of subjects will participate for imaging assessment

Group Type: EXPERIMENTAL

Arm 2: Frontal Lobe Epilepsy

Intervention Type: DEVICE

Positron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI

Arm 3: Normal Controls

Normal Controls, eligible subjects don't have Juvenile Myoclonic Epilepsy or Frontal Lobe Epilepsy will be placed in this group

Group Type: EXPERIMENTAL

Arm 3: Normal Controls

Intervention Type: DEVICE

Positron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI

Interventions

Arm 1: Juvenile Myoclonic Epilepsy

Positron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI

Intervention Type: DEVICE

Arm 2: Frontal Lobe Epilepsy

Positron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI

Intervention Type: DEVICE

Arm 3: Normal Controls

Positron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI

Intervention Type: DEVICE

Eligibility Criteria

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).

• 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)

• 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

• 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):

• 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):

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Min-Ying (Lydia) Su

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Min-Ying Su, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

Center for Functional Onco-Imaging, University of California

Irvine, California, United States

Countries

United States

Other Identifiers

VA-821/103

Identifier Type: OTHER

Identifier Source: secondary_id

UCI-HS-2003-3252

Identifier Type: -

Identifier Source: org_study_id