Clinical trial NCT00859794: An Examination of Cognitive and Sensorimotor Processes in Patients With Epilepsy
Official title: An Examination of Cognitive and Sensorimotor Processes in Patients With Epilepsy Using Electrophysiology, Cortical Mapping, Electrical Brain Stimulation, and fMRI
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Epilepsy
Keywords: Epilepsy
fMRI
Electrophysiology
Cortical Mapping
Neurosurgery
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2009-03-11
Enrollment: 450
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patient is under the age of 5

Primary outcomes:
measure: Decrease in seizure frequency after epilepsy surgical treatment
timeFrame: up to 4 weeks
measure: Change in electrophysiological markers (local field potential power and phase) during cognitive tasks
timeFrame: up to 4 weeks
measure: Change in memory performance
timeFrame: up to 4 weeks
measure: Change in decision-making performance
timeFrame: up to 4 weeks
measure: Change in sensory perception
timeFrame: up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Great Neck
country: United States
facility: Comprehensive Epilepsy Care Center
state: New York
Study officials:
affiliation: Zucker School of Medicine at Hofstra/Northwell and Feinstein Institute for Medical Research
name: Ashesh Mehta, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: