An Examination of Cognitive and Sensorimotor Processes in Patients With Epilepsy

Sponsor
Northwell Health (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT00859794
Collaborator
(none)
200
1
181
1.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: fMRI
  • Other: Releasing Data
  • Other: Neuropsychological Testing
  • Other: Additional electrode implantation
  • Other: Brain 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 (tES) 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
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
Study Start Date :
Nov 1, 2007
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Outcome Measures

Primary Outcome Measures

  1. epilepsy surgical outcome [1 year minimum]

    We are primarily interested in finding ways of predicting the effects of epilepsy surgery on seizure control and cognitive function.

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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., Zucker School of Medicine at Hofstra/Northwell and Feinstein Institute for Medical Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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
Other Study ID Numbers:
  • GCRC 0258
First Posted:
Mar 11, 2009
Last Update Posted:
Nov 11, 2021
Last Verified:
Nov 1, 2021
Keywords provided by Ashesh D. Mehta, Director of Epilepsy Surgery, Cushing Neuroscience Institute; Assistant Investigator, The Feinstein Institute for Medical Research, Northwell Health
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 11, 2021