Viewing Study NCT00195052



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Last Modification Date: 2024-10-26 @ 9:17 AM
Study NCT ID: NCT00195052
Status: RECRUITING
Last Update Posted: 2023-08-21
First Post: 2005-09-14

Brief Title: Intrinsic Optical Imaging Study to Map Neocortical Seizure in Human Epilepsy Patients
Sponsor: Weill Medical College of Cornell University
Organization: Weill Medical College of Cornell University

Study Overview

Official Title: Intraoperative Optical Mapping of Human Epileptiform and Functional Cortex
Status: RECRUITING
Status Verified Date: 2024-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None