跳至主要内容
临床试验/NCT00859794
NCT00859794Enrolling By Invitation不适用

An Examination of Cognitive and Sensorimotor Processes in Patients With Epilepsy Using Electrophysiology, Cortical Mapping, Electrical Brain Stimulation, and fMRI

Northwell Health2 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2007年11月最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
450
试验地点
2
主要终点
Change in electrophysiological markers (local field potential power and phase) during cognitive tasks

研究概览

简要总结

The overall goal of this project is to better understand the micro-physiology of human epilepsy and cognition using the intracranial electroencephalogram (iEEG), electrical brain stimulation, functional magnetic resonance imaging (fMRI), and histology.

详细描述

The overall goal of this project is to better understand the micro-physiology of human epilepsy and cognition using iEEG, electrical brain stimulation, fMRI, and histology.

Specific AIM 1: Mapping cognitive networks using intracranial electrodes, functional magnetic resonance imaging, and cognitive tasks. To identify brain areas and mechanisms involved in cognitive function we will ask participants to perform tasks while their brain activity is measured with intracranial electrodes or functional magnetic resonance imaging (fMRI).

Specific AIM 2: Using microelectrodes to better understand the mechanisms of seizure genesis/spread and human cognitive function. We will use microelectrodes to measure activity within single neurons, data that will allow us to tease apart incoming and outgoing activity to a brain area.

Specific AIM 3: Using macroscale measures of brain connectivity to map functional and epileptogenic brain areas. We will measure connectivity between macroscale brain regions via variety of techniques: diffusion tensor imaging (DTI), fMRI, cortico-cortical evoked potentials (CCEP), and intracranial electrophysiology. We believe that epileptogenic and functional regions will be mutually segregated by their connectivity patterns.

Specific AIM 4: Using EEG/iEEG source localization to better identify the sources of epileptiform activity. We will construct models of participants' heads via MRI and CT, which will potentially allow us to localize the neural generators of EEG and iEEG recordings.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
5 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects are selected on the basis of intractability of their seizures to medical intervention by antiepileptic drugs and following a noninvasive workup that indicates the patient would be an excellent candidate for resective surgery.

排除标准

  • Patient is under the age of 5

结局指标

主要结局

Change in electrophysiological markers (local field potential power and phase) during cognitive tasks

时间窗: up to 4 weeks

We will compare brain recordings during distinct cognitive functional states, as defined by performance and participation in cognitive tasks (typically task vs resting state). Power and phase measures isolated from local field potentials in implanted electrodes will be assessed. Neuronal firing rates will also be assessed.

Change in memory performance

时间窗: up to 4 weeks

We will measure the change in memory performance in memory tasks (percent of items correctly recalled).

Change in decision-making performance

时间窗: up to 4 weeks

We will measure the change in performance (reaction time and accuracy) in decision-making tasks.

Decrease in seizure frequency after epilepsy surgical treatment

时间窗: up to 4 weeks

We are interested in identifying specific factors that predict the effects of epilepsy surgery on seizure control. We will start by assessing electrographic (seizure foci and spread), imaging (cortical volume, presence of structural pathology), and surgical (extent of surgical resection) factors.

Change in sensory perception

时间窗: up to 4 weeks

We will measure the change in performance in auditory/visual perception tasks (percent of items correctly perceived).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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