Neocortical Epilepsies - Do They Progress?

NCT00610558 | Completed Results

• 2 other identifiers: UCI-HS-2003-3252VA-821/103
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Arm 1: Juvenile Myoclonic Epilepsy

EXPERIMENTAL

Juvenile Myoclonic Epilepsy group of subjects will participate for imaging assessment

Device: Arm 1: Juvenile Myoclonic Epilepsy

Arm 2: Frontal Lobe Epilepsy

EXPERIMENTAL

Frontal Lobe Epilepsy group of subjects will participate for imaging assessment

Device: Arm 2: Frontal Lobe Epilepsy

Arm 3: Normal Controls

EXPERIMENTAL

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

Interventions

Arm 1: Juvenile Myoclonic Epilepsy DEVICE

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

Arm 1: Juvenile Myoclonic Epilepsy

Arm 2: Frontal Lobe Epilepsy DEVICE

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

Arm 2: Frontal Lobe Epilepsy

Arm 3: Normal Controls DEVICE

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

Arm 3: Normal Controls

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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 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)
• History of significant head injury (\> 30 min loss of consciousness)
• Use of neuroleptic drugs or sedative doses of antianxiety or antidepressant drugs

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

Center for Functional Onco-Imaging, University of California

Irvine, California, 92697, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Dr. Lydia Su
• Organization: University of California, Irvine

msu@uci.edu

(949) 824-4925

Study Officials

• Min-Ying Su, PhD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Three different Groups in this study: Juvenile Myoclonic Epilepsy, Frontal Lobe Epilepsy, Normal Controls

Study Record Dates

• First Submitted: January 12, 2008
• First Posted: February 8, 2008
• Study Start: July 1, 2003
• Primary Completion: June 1, 2009
• Study Completion: September 1, 2010
• Last Updated: November 20, 2019
• Results First Posted: November 20, 2019

Record last verified: 2019-11

Locations

US (1)