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

NCT00195052 | Terminated

• 1 other identifier: 0102004808
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Keywords

epilepsy; optical imaging; optical mapping

Outcome Measures

Primary Outcomes (1)

• Positive identification of language areas with optical imaging

  During surgery (20-30 minutes)

Study Arms (1)

Epilepsy Patients

Diagnostic Test: Intrinsic signal imaging of human cortex

Interventions

Intrinsic signal imaging of human cortex DIAGNOSTIC_TEST

Light is shined on the brain at 540 nm and 610 nm and images are acquired at 10 frames per second.

Epilepsy Patients

Eligibility Criteria

• Age: 6 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Subjects NOT undergoing neurosurgical operations requiring cortical mapping.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College/New York Presbyterian Hospital

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Theodore H Schwartz, MD

  Weill Cornell Medical College/New York Presbyterian Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 19, 2005
• Study Start: May 1, 2002
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)