NCT00859794

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
34mo left

Started Nov 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Nov 2007Feb 2029

Study Start

First participant enrolled

November 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 11, 2009

Completed
19.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2029

Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

21.3 years

First QC Date

March 10, 2009

Last Update Submit

January 29, 2024

Conditions

Epilepsy

Keywords

EpilepsyfMRIElectrophysiologyCortical MappingNeurosurgery

Outcome Measures

Primary Outcomes (5)

  • Decrease in seizure frequency after epilepsy surgical treatment

    We are interested in identifying specific factors that predict the effects of epilepsy surgery on seizure control. We will start by assessing electrographic (seizure foci and spread), imaging (cortical volume, presence of structural pathology), and surgical (extent of surgical resection) factors.

    up to 4 weeks

  • Change in electrophysiological markers (local field potential power and phase) during cognitive tasks

    We will compare brain recordings during distinct cognitive functional states, as defined by performance and participation in cognitive tasks (typically task vs resting state). Power and phase measures isolated from local field potentials in implanted electrodes will be assessed. Neuronal firing rates will also be assessed.

    up to 4 weeks

  • Change in memory performance

    We will measure the change in memory performance in memory tasks (percent of items correctly recalled).

    up to 4 weeks

  • Change in decision-making performance

    We will measure the change in performance (reaction time and accuracy) in decision-making tasks.

    up to 4 weeks

  • Change in sensory perception

    We will measure the change in performance in auditory/visual perception tasks (percent of items correctly perceived).

    up to 4 weeks

Study Arms (1)

Cognitive and Behavioral Testing

EXPERIMENTAL

Participants will participate in cognitive tasks where brain recordings and task performance will be monitored and recorded.

Other: fMRIOther: Neuropsychological TestingOther: Additional electrode implantationOther: Electrical brain stimulation

Interventions

fMRIOTHER

Subjects will perform cognitive tasks during MRI scanning sessions to gather data about cognitive functions.

Cognitive and Behavioral Testing
Neuropsychological TestingOTHER

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.

Cognitive and Behavioral Testing
Additional electrode implantationOTHER

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.

Cognitive and Behavioral Testing
Electrical brain stimulationOTHER

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.

Cognitive and Behavioral Testing

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patient is under the age of 5

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Comprehensive Epilepsy Care Center

Great Neck, New York, 11021, United States

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Neuropsychological TestsDeep Brain Stimulation

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and ActivitiesElectric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Ashesh Mehta, M.D., Ph.D.

    Zucker School of Medicine at Hofstra/Northwell and Feinstein Institute for Medical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2009

First Posted

March 11, 2009

Study Start

November 1, 2007

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

February 1, 2029

Last Updated

February 1, 2024

Record last verified: 2024-01

Locations

US(1)