Neocortical Epilepsies - Do They Progress?

Epilepsy Clinical Trial

Official title:

Neocortical Epilepsies - Do They Progress?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00610558
• Other study ID #: UCI-HS-2003-3252
• Secondary ID: VA-821/103
• Status: Completed
• Phase: N/A
• Start date: July 2003
• Est. completion date: September 2010

Study information

• Verified date: November 2019
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2010
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

Device:
• Arm 1: Juvenile Myoclonic Epilepsy
Positron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI
• Arm 2: Frontal Lobe Epilepsy
Positron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI
• Arm 3: Normal Controls
Positron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI

Locations

Country	Name	City	State
United States	Center for Functional Onco-Imaging, University of California	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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