Набор по приглашению NCT00859794

An Examination of Cognitive and Sensorimotor Processes in Patients With Epilepsy

Без фазы С лечением Epilepsy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: fMRI, Neuropsychological Testing, Additional electrode implantation, Electrical brain stimulation.
Кому может быть актуально: Состояния в реестре: Epilepsy. Базовые параметры: от 5 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Specific AIM 5: Investigating the effects of transcranial and direct electrical stimulation on cortical excitability and cognitive function. We will apply direct electrical brain stimulation to epileptogenic and functional brain regions and evaluate the effects of this stimulation on electrode recordings, CCEPs, and cognitive tasks. Electrical stimulation may be applied with consideration of endogenous cognitive biomarkers to probe and elucidate the function of these biomarkers as they relate to cognitive function.

Specific AIM 6: Studying local connectivity of epileptic brain tissue with histology. We will reserve a small portion of resected brain tissue from patients who have undergone surgical resection for histological analysis to better understand altered patterns of neural connectivity in epilepsy.

Вмешательства

Другое fMRI
Subjects will perform cognitive tasks during MRI scanning sessions to gather data about cognitive functions.
Другое Neuropsychological Testing
Subjects will have a neuropsych evaluation as part of their standard of care for surgery. The research team is asking the subject to release their neuropsychological evaluations for analysis.
Другое Additional electrode implantation
Subjects will typically have between 100-300 electrodes implanted as part of their surgery. Additional electrodes will be implanted that are able to record from smaller, more specific parts of the brain. This will allow for better understanding of how the brain is wired.
Другое Electrical brain stimulation
Intracranial or extracranial electrodes will be used to deliver electrical brain stimulation (amplitude 0.5-8.0mA) or sham stimulation of between 0.4 and 3000 milliseconds during cognitive task periods.

Первичные конечные точки

Decrease in seizure frequency after epilepsy surgical treatment [Срок оценки: up to 4 weeks]
Change in electrophysiological markers (local field potential power and phase) during cognitive tasks [Срок оценки: up to 4 weeks]
Change in memory performance [Срок оценки: up to 4 weeks]
Change in decision-making performance [Срок оценки: up to 4 weeks]
Change in sensory perception [Срок оценки: up to 4 weeks]

Критерии участия

Критерии включения

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.