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, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00859794
First received: March 10, 2009
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

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


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

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 North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • epilepsy surgical outcome [ Time Frame: 1 year minimum ] [ Designated as safety issue: No ]
    We are primarily interested in finding ways of predicting the effects of epilepsy surgery on seizure control and cognitive function.


Estimated Enrollment: 15
Study Start Date: November 2007
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (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.
Detailed Description:

The overall goal of this project is to better understand the micro-physiology of human epilepsy and cognition using iEEG, Stimulation Mapping, and fMRI.

Specific AIM 1: Identifying laminar activity during seizures using intracranial electrodes. This will help to better characterize the neuronal path of ictal activity in the human brain. Exploring the relationship of intracranial electroencephalographic recordings and stimulation mapping will allow us to study the organization of seizure propagation in the cortex. The use of laminar probes should enable us to explore the organization of networks that underlie seizure generation and propagation as may be revealed by recording from different layers of the cortex.

Specific AIM 2: Elucidating cognitive networks using intracranial electrodes. We will be investigating the functional connectivity of cognitive networks and information processing in the brain. Multiple aspects of language processing including word generation, auditory comprehension, and naming will be studied in order to help build a working model of language processing in the brain. We will also explore how the brain processes human faces and the network it uses to do so. Sensory and motor processing networks will be investigated as well. The use of laminar probes will help us to determine the hierarchical organization of these processing networks.

Specific AIM 3: Identifying the relationship between fMRI, electrophysiology and stimulation mapping. We will also be studying the relationship of pre-operative fMRI and cortical stimulation mapping in order to locate critical sites in the information processing network for language. Cortical localization of these sites may assist in the guidance of neurosurgical resections of eloquent cortex. The relationship between areas highlighted by fMRI and stimulation mapping will be explored.

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
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
North Shore Long Island Jewish Health System
Investigators
Principal Investigator: Ashesh Mehta, M.D., Ph.D. Hofstra North Shore LIJ School of Medicine and Feinstein Institute for Medical Research
  More Information

No publications provided

Responsible Party: Ashesh D. Mehta, Director of Epilepsy Surgery, Cushing Neuroscience Institute; Assistant Investigator, The Feinstein Institute for Medical Research, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT00859794     History of Changes
Other Study ID Numbers: GCRC 0258
Study First Received: March 10, 2009
Last Updated: May 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
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 July 23, 2014