EpilepsyNCT00195052
Intrinsic Optical Imaging Study to Map Neocortical Seizure in Human Epilepsy Patients
An observational study of Epilepsy, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 65 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Intrinsic signal imaging of human cortex
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- May 2002to Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Medically intractable epilepsy
- Subjects undergoing neurosurgical operations requiring cortical mapping
Who cannot join
- Subjects NOT undergoing neurosurgical operations requiring cortical mapping.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College/New York Presbyterian Hospital
New York, New York, 10021
About this study
Official title: 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.
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.
- Conditions
- Epilepsy
- Being tested
- Intrinsic signal imaging of human cortex
- Keywords
- epilepsy, optical imaging, optical mapping
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrinsic signal imaging of human cortexDiagnostic test
Light is shined on the brain at 540 nm and 610 nm and images are acquired at 10 frames per second.
| Study group | Role | What they receive |
|---|---|---|
| Epilepsy Patients | Not described Receives: Diagnostic Test: Intrinsic signal imaging of human cortex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive identification of language areas with optical imaging
Measured: During surgery (20-30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startMay 2002
- Primary completionApr 2025
- Study completionApr 2025
Why it stopped: The study is terminating prematurely as Dr. Schwartz is no longer at WCM, and the study cannot feasibly be completed in his absence.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Theodore H Schwartz, MD, Principal investigator, Weill Cornell Medical College/New York Presbyterian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00195052
- Sponsor's protocol ID
- 0102004808
- Status last verified
- Jun 2025
- First submitted
- 14 Sep 2005
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Optical Mapping of Human Epileptiform and Functional Cortex
- ClinicalTrials.gov ID
- NCT00195052
- Acronym / sponsor ID
- 0102004808
- Conditions
- Epilepsy
- Keywords
- epilepsy, optical imaging, optical mapping
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study is terminating prematurely as Dr. Schwartz is no longer at WCM, and the study cannot feasibly be completed in his absence.
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- May 2002 (actual)
- Primary completion
- Apr 2025 (actual)
- Study completion
- Apr 2025 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epilepsy Patients | – | Diagnostic Test: Intrinsic signal imaging of human cortex |
Who may qualify
- Ages
- 6 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Medically intractable epilepsy
- Subjects undergoing neurosurgical operations requiring cortical mapping
Key exclusion criteria (1 listed)
- Subjects NOT undergoing neurosurgical operations requiring cortical mapping.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrinsic signal imaging of human cortexLight is shined on the brain at 540 nm and 610 nm and images are acquired at 10 frames per second. | Diagnostic test | Epilepsy Patients |
Primary outcome
Positive identification of language areas with optical imaging
Time frame: During surgery (20-30 minutes)
Results and safety
The study was stopped early (reason given: The study is terminating prematurely as Dr. Schwartz is no longer at WCM, and the study cannot feasibly be completed in his absence.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theodore H Schwartz, MD principal investigator
Weill Cornell Medical College/New York Presbyterian Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study is terminating prematurely as Dr. Schwartz is no longer at WCM, and the study cannot feasibly be completed in his absence.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive identification of language areas with optical imaging (time frame: During surgery (20-30 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025; AzTrials last refreshed its copy on 6 Nov 2026.