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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by Weill Medical College of Cornell University
Sponsor:
Information provided by (Responsible Party):
Theodore H. Schwartz, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00195052
First received: September 14, 2005
Last updated: January 28, 2016
Last verified: January 2016

September 14, 2005
January 28, 2016
May 2002
December 2018   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00195052 on ClinicalTrials.gov Archive Site
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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.
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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
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.
Epilepsy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2018
December 2018   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Subjects NOT undergoing neurosurgical operations requiring cortical mapping.
Both
6 Years to 65 Years   (Child, Adult)
No
Contact: Theodore H Schwartz, MD 212-746-5620 schwarh@med.cornell.edu
Contact: Hongtao Ma, Ph.D. 212-746-5516 hom2001@med.cornell.edu
United States
 
NCT00195052
0102004808
No
No
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Theodore H. Schwartz, Weill Medical College of Cornell University
Weill Medical College of Cornell University
Not Provided
Principal Investigator: Theodore H Schwartz, MD Weill Cornell Medical College/New York Presbyterian Hospital
Weill Medical College of Cornell University
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP