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Neocortical Epilepsies - Do They Progress?

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00610558
First Posted: February 8, 2008
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Min-Ying (Lydia) Su, University of California, Irvine
  Purpose
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.

Condition Intervention
Epilepsy Device: positron emission tomography (PET)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Neocortical Epilepsies - Do They Progress?

Resource links provided by NLM:


Further study details as provided by Min-Ying (Lydia) Su, University of California, Irvine:

Primary Outcome Measures:
  • We hope to provide evidence that temporal lobe epilepsy is not the only syndrome which suffers from progressive memory loss, volume loss, hypometabolism and loss of seizure control. [ Time Frame: at completion of the study ]

Secondary Outcome Measures:
  • We hope to be able to reassure subjects with primary generalized epilepsy (JME) that while they may have some isolated difficulties with certain tasks, they do not have a progressive disorder. [ Time Frame: at completion of study ]

Enrollment: 43
Study Start Date: July 2003
Study Completion Date: September 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: positron emission tomography (PET)
    FDG-glucose (10 mCi)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00610558


Locations
United States, California
Center for Functional Onco-Imaging, University of California
Irvine, California, United States, 92697
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Min-Ying Su, PhD University of California, Irvine
  More Information

Responsible Party: Min-Ying (Lydia) Su, Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00610558     History of Changes
Other Study ID Numbers: UCI-HS-2003-3252
VA-821/103
First Submitted: January 12, 2008
First Posted: February 8, 2008
Last Update Posted: October 12, 2017
Last Verified: June 2013

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases