Intrinsic Optical Imaging Study to Map Neocortical Seizure in Human Epilepsy Patients

Intraoperative Optical Mapping of Human Epileptiform and Functional Cortex

The purpose of this study is to develop a technique for the intraoperative identification of human functional and epileptiform cortex using intrinsic signal imaging. The investigators propose that the ability to optically monitor neuronal activity in a large area of cortex in "real-time" will be a more sensitive and time-saving method than the electrical methods currently available. The applications of this technique will not only theoretically increase the safety and efficacy of many of neurosurgical procedures, but will be useful as an investigational tool to study human cortical physiology.

Study Overview

• Status: Recruiting
• Conditions: Epilepsy
• Intervention / Treatment: Diagnostic test: Intrinsic signal imaging of human cortex

Detailed Description

Epilepsy is a disease affecting 1-2% of the population. Currently, the only known cure for epilepsy is surgery, which is much more effective at eliminating seizures arising from the medial temporal lobe compared with the neocortex. The problem with neocortical epilepsy is that the population of neurons underlying each epileptiform discharge varies over time. In addition, the spatial relationship between interictal events and the ictal onset zones, which are critical in defining the region of epileptogenesis, is not well understood and essential to the surgical treatment of epilepsy. Electrophysiological recording methods, although currently the "gold standard" in mapping epilepsy, are inadequate to address these questions based on restrictions due to volume conduction or sampling limitations. Optical recording techniques can overcome many of these limitations by sampling large areas of cortex simultaneously to provide information about blood flow, metabolism and extracellular fluid shifts that are intimately related to excitatory and inhibitory neuronal activity. In fact, optical recordings may actually be more sensitive to certain aspects of epileptic activity than electrophysiologic recordings. The goal will be to translate these findings into the operating room and map human neocortical epilepsy with the same optical techniques. Outcome following surgical resections to treat neocortical epilepsy will be correlated with the optical maps to determine the utility of intrinsic signal imaging in guiding brain surgery. These experiments will set the groundwork for implementing optical recordings in general clinical practice as a novel technique for mapping and predicting human seizures.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Theodore H Schwartz, MD; Phone Number: 212-746-5620; Email: schwarh@med.cornell.edu
• Study Contact Backup: Name: Hongtao Ma, Ph.D.; Phone Number: 212-746-5516; Email: hom2001@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • Weill Cornell Medical College/New York Presbyterian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The patient, who is going to undergo a neurosurigcal procedure which will require intraoperative brain mapping to determine the brain organization, is the potential study subject.

Description

Inclusion Criteria:

• Medically intractable epilepsy
• Subjects undergoing neurosurgical operations requiring cortical mapping

Exclusion Criteria:

• Subjects NOT undergoing neurosurgical operations requiring cortical mapping.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Epilepsy Patients	Diagnostic test: Intrinsic signal imaging of human cortex; Light is shined on the brain at 540 nm and 610 nm and images are acquired at 10 frames per second.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Positive identification of language areas with optical imaging	During surgery (20-30 minutes)

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Theodore H Schwartz, MD, Weill Cornell Medical College/New York Presbyterian Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2002
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 14, 2005
• First Submitted That Met QC Criteria: September 14, 2005
• First Posted (Estimated): September 19, 2005

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 17, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: epilepsy; optical imaging; optical mapping
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: 0102004808

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO