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An Examination of Cognitive and Sensorimotor Processes in Patients With Epilepsy

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Ashesh D. Mehta, Northwell Health
ClinicalTrials.gov Identifier:
NCT00859794
First received: March 10, 2009
Last updated: January 13, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention
Epilepsy
Other: fMRI
Other: Releasing Data
Other: Neuropsychological Testing
Other: Additional electrode implantation
Other: Brain stimulation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: An Examination of Cognitive and Sensorimotor Processes in Patients With Epilepsy Using Electrophysiology, Cortical Mapping, and fMRI

Resource links provided by NLM:


Further study details as provided by Northwell Health:

Primary Outcome Measures:
  • epilepsy surgical outcome [ Time Frame: 1 year minimum ]
    We are primarily interested in finding ways of predicting the effects of epilepsy surgery on seizure control and cognitive function.


Estimated Enrollment: 200
Study Start Date: November 2007
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: fMRI
    Subjects will undergo MRI scanning to gather data about cognitive functions.
    Other: Releasing Data
    Subjects in the study will be asked to release data about their surgery, and electrostimulation to the research team for analysis.
    Other: 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 neuropsych evaluations for analysis.
    Other: Additional electrode implantation
    Subjects normally will have anywhere from 100-200 electrodes implanted as part of their surgery. As part of the study, we would implant 1-2 electrodes that are able to record from smaller, more specific parts of the brain to better understand how your brain is wired.
    Other: Brain stimulation
    Subjects may be asked to undergo additional electrical brain stimulation (in addition to what is required for clinical purposes) to map brain function and epileptogenic areas. This may include extended stimulation mapping, low frequency stimulation (CCEPs), and transcranial stimulation.
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 and spread. 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 electrical stimulation on cortical excitability and cognitive function. We will apply tES to epileptogenic and functional brain regions and evaluate the effects of this stimulation on microelectrode recordings, CCEPs, and cognitive tasks.

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

Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who are excellent candidates for resective surgery selected on the basis of intractability of their seizures to medical intervention by antiepileptic drugs and following a noninvasive workup.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00859794

Locations
United States, New York
Comprehensive Epilepsy Care Center
Great Neck, New York, United States, 11021
Sponsors and Collaborators
Northwell Health
Investigators
Principal Investigator: Ashesh Mehta, M.D., Ph.D. Hofstra North Shore LIJ School of Medicine and Feinstein Institute for Medical Research
  More Information

Responsible Party: Ashesh D. Mehta, Director of Epilepsy Surgery, Cushing Neuroscience Institute; Assistant Investigator, The Feinstein Institute for Medical Research, Northwell Health
ClinicalTrials.gov Identifier: NCT00859794     History of Changes
Other Study ID Numbers: GCRC 0258
Study First Received: March 10, 2009
Last Updated: January 13, 2017

Keywords provided by Northwell Health:
Epilepsy
fMRI
Electrophysiology
Cortical Mapping
Neurosurgery

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 22, 2017