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Completed

NCT Number: NCT00610558

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Functional Onco-Imaging, University of California

Irvine, California, 92697, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arm 1: Juvenile Myoclonic Epilepsy

Device

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

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

Primary outcomes

  1. Functional Connectivity

    Time frame: During Imaging Session

    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.

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Important dates

Study start
2003
Primary completion
2009
Study completion
2010
First posted
Feb 8, 2008
Registry last updated
Nov 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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