Viewing Study NCT00001554



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Last Modification Date: 2024-10-26 @ 9:02 AM
Study NCT ID: NCT00001554
Status: COMPLETED
Last Update Posted: 2008-03-04
First Post: 1999-11-03

Brief Title: Infrared Camera for Brain Mapping During Surgery
Sponsor: National Institute of Neurological Disorders and Stroke NINDS
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: Intraoperative Infrared Functional Brain Mapping
Status: COMPLETED
Status Verified Date: 1999-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
96-N-0093 None None None