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

NCT ID: NCT00195052

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 34 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2002-05-31
• Study Completion Date: 2025-04-30

Brief Summary

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.

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.

Conditions

Epilepsy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Epilepsy Patients

Intrinsic signal imaging of human cortex

Intervention Type: DIAGNOSTIC_TEST

Light is shined on the brain at 540 nm and 610 nm and images are acquired at 10 frames per second.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Subjects NOT undergoing neurosurgical operations requiring cortical mapping.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Theodore H Schwartz, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Cornell Medical College/New York Presbyterian Hospital

Locations

Weill Cornell Medical College/New York Presbyterian Hospital

New York, New York, United States

Countries

United States

Other Identifiers

0102004808

Identifier Type: -

Identifier Source: org_study_id