Infrared Camera for Brain Mapping During Surgery
Primary Purpose
Epilepsy, Neurologic Manifestations
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
intraoperative infrared (IR) neuroimaging
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Cortical Localization, Optical Imaging, Thermal Imaging
Eligibility Criteria
Adult patients who will be undergoing craniotomy for lesions such as tumor, epileptic focus, vascular malformation or infection. Adult patients who are able to provide informed consent.
Sites / Locations
- National Institute of Neurological Disorders and Stroke (NINDS)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00001554
First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
1. Study Identification
Unique Protocol Identification Number
NCT00001554
Brief Title
Infrared Camera for Brain Mapping During Surgery
Official Title
Intraoperative Infrared Functional Brain Mapping
Study Type
Interventional
2. Study Status
Record Verification Date
May 1999
Overall Recruitment Status
Completed
Study Start Date
June 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2000 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
4. Oversight
5. Study Description
Brief Summary
It is extremely important to identify and distinguish healthy brain tissue from diseased brain tissue during neurosurgery. If normal tissue is damaged during neurosurgery it can result in long term neurological problems for the patient.
The brain tissue as it appears prior to the operation on CT scan and MRI is occasionally very different from how it appears during the actual operation. Therefore, it is necessary to develop diagnostic procedures that can be used during the operation
Presently, the techniques used for intraoperative mapping of the brain are not reliable in all cases in which they are used. Researchers in this study have developed a new approach that may allow diseased brain tissue to be located during an operation with little risk. This new approach uses nfrared technology to locate the diseased tissue and identify healthy brain tissue.
The goal of this study is to investigate the clinical use of intraoperative infrared (IR) neuroimaging to locate diseased tissue and distinguish it from normal functioning tissue during the operation.
Detailed Description
It is important during neurosurgical procedures to identify and preserve eloquent functional cortex adjacent to a resectable lesion. Resection of a lesion infiltrating vital cerebral cortex can be associated with postoperative neurological deficits if the surgeon cannot clearly distinguish between the infiltrating borders of a lesion and surrounding functionally eloquent tissue. Spatial relationships between a lesion and surrounding normal brain can change significantly from those determined by preoperative methods such as CT and MRI scans. Necessary intraoperative interventions such as cerebrospinal fluid drainage, osmotic diuresis and lesion debulking cause quantitatively unpredictable brain shift in three dimensions. Therefore functional localization in real time that can be performed in the operating room is desirable. However, intraoperative real-time functional mapping techniques now available cannot be used in many surgical situations and are not sufficiently reliable in all cases in which they are used.
We have developed an intraoperative approach that may permit reliable lesion localization and brain functional mapping in real time with minimal risk. This approach makes use of infrared technology to identify functionally active eloquent cortex and may differentiate abnormal tissue from normal cortex.
The goal of this study is to investigate the clinical use of intraoperative infrared (IR) neuroimaging to differentiate intracranial lesions from surrounding normal functionally important tissue in real time. Reliable real-time intraoperative functional mapping of eloquent cortex adjacent to lesions by this technique would improve the safety and effectiveness of many neurosurgical procedures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Neurologic Manifestations
Keywords
Cortical Localization, Optical Imaging, Thermal Imaging
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
80 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
intraoperative infrared (IR) neuroimaging
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Adult patients who will be undergoing craniotomy for lesions such as tumor, epileptic focus, vascular malformation or infection.
Adult patients who are able to provide informed consent.
Facility Information:
Facility Name
National Institute of Neurological Disorders and Stroke (NINDS)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
8542979
Citation
Brugge JF, Poon PW, So AT, Wu BM, Chan FH, Lam FK. Thermal images of somatic sensory cortex obtained through the skull of rat and gerbil. Exp Brain Res. 1995;106(1):7-18. doi: 10.1007/BF00241352.
Results Reference
background
PubMed Identifier
8362657
Citation
George JS, Lewine JD, Goggin AS, Dyer RB, Flynn ER. IR thermal imaging of a monkey's head: local temperature changes in response to somatosensory stimulation. Adv Exp Med Biol. 1993;333:125-36. doi: 10.1007/978-1-4899-2468-1_12. No abstract available.
Results Reference
background
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Infrared Camera for Brain Mapping During Surgery
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