Neocortical Epilepsies - Do They Progress?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Functional Connectivity
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Functional Connectivity
时间窗: 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.
次要结局
未报告次要终点
研究者
Min-Ying (Lydia) Su
Professor
University of California, Irvine