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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
Information provided by (Responsible Party):
Theodore H. Schwartz, Weill Medical College of Cornell University Identifier:
First received: September 14, 2005
Last updated: January 28, 2016
Last verified: January 2016
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 Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Intraoperative Optical Mapping of Human Epileptiform and Functional Cortex

Resource links provided by NLM:

Further study details as provided by Weill Medical College of Cornell University:

Estimated Enrollment: 40
Study Start Date: May 2002
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   6 Years to 65 Years   (Child, Adult)
Genders Eligible for Study:   Both
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.

Inclusion Criteria:

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

Exclusion Criteria:

  • Subjects NOT undergoing neurosurgical operations requiring cortical mapping.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00195052

Contact: Theodore H Schwartz, MD 212-746-5620
Contact: Hongtao Ma, Ph.D. 212-746-5516

United States, New York
Weill Cornell Medical College/New York Presbyterian Hospital Recruiting
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Principal Investigator: Theodore H Schwartz, MD Weill Cornell Medical College/New York Presbyterian Hospital
  More Information

Responsible Party: Theodore H. Schwartz, Principal Investigator, Weill Medical College of Cornell University Identifier: NCT00195052     History of Changes
Other Study ID Numbers: 0102004808 
Study First Received: September 14, 2005
Last Updated: January 28, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Weill Medical College of Cornell University:
optical imaging
optical mapping

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases processed this record on October 27, 2016