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

Epilepsy Clinical Trial

Official title:

Intraoperative Optical Mapping of Human Epileptiform and Functional Cortex

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00195052
• Other study ID #: 0102004808
• Status: Recruiting
• Start date: May 2002
• Est. completion date: December 2025

Study information

• Verified date: August 2023
• Source: Weill Medical College of Cornell University
• Contact: Theodore H Schwartz, MD
• Phone: 212-746-5620
• Email: schwarh[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 65 Years

Eligibility

Inclusion Criteria:

• Medically intractable epilepsy

• Subjects undergoing neurosurgical operations requiring cortical mapping

Exclusion Criteria:

• Subjects NOT undergoing neurosurgical operations requiring cortical mapping.

Related Conditions & MeSH terms

• Epilepsy

Intervention

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.

Locations

Country	Name	City	State
United States	Weill Cornell Medical College/New York Presbyterian Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive identification of language areas with optical imaging		During surgery (20-30 minutes)