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Neocortical Epilepsies - Do They Progress?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Min-Ying (Lydia) Su, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00610558
First received: January 12, 2008
Last updated: June 19, 2013
Last verified: June 2013
  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: Open Label
Primary Purpose: Diagnostic
Official Title: Neocortical Epilepsies - Do They Progress?

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 12, 2008
Last Updated: June 19, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 20, 2014