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TerminatedNCT00195052Updated Jun 24, 2025

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

An observational study in Epilepsy, sponsored by Weill Medical College of Cornell University. Terminated at 1 site in United States. Open to participants aged 6 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-06-24.

Sponsored by Weill Medical College of Cornell University · Observational

Why this study was terminated
The study is terminating prematurely as Dr. Schwartz is no longer at WCM, and the study cannot feasibly be completed in his absence.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
34
Ages
6 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Epilepsy

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Keywords

  • epilepsy
  • optical imaging
  • optical mapping
03

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 34 is below the median of 102 across 521 observational studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

Weill Medical College of Cornell University is the lead sponsor of 867 studies on the registry; 160 are open to participants now.

Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 65 Years
Sexes eligible
All
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

Exclusion Criteria:

  • Subjects NOT undergoing neurosurgical operations requiring cortical mapping.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
34 participants (actual)
Patient registry
No

Groups and cohorts

  • Epilepsy Patients

    Diagnostic Test: Intrinsic signal imaging of human cortex

Interventions

  • Diagnostic testIntrinsic 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.

06

What researchers measure

Primary outcomes

  1. Positive identification of language areas with optical imaging

    Time frame: During surgery (20-30 minutes)

07

Study locations

1 site
  • Weill Cornell Medical College/New York Presbyterian Hospital
    New York, New York 10021, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00195052
Lead sponsor
Weill Medical College of Cornell University
Responsible party
Sponsor
First posted
Sep 19, 2005
Start date
May 2002
Primary completion
Apr 2025
Completion
Apr 2025
Last update
Jun 24, 2025

Study contacts

Theodore H Schwartz, MD
principal investigator · Weill Cornell Medical College/New York Presbyterian Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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