Infrared Camera for Brain Mapping During Surgery

Epilepsy Clinical Trial

Official title:

Intraoperative Infrared Functional Brain Mapping

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001554
• Other study ID #: 960093
• Secondary ID: 96-N-0093
• Status: Completed
• Phase: Phase 1
• First received: November 3, 1999
• Last updated: March 3, 2008
• Start date: June 1996
• Est. completion date: June 2000

Study information

• Verified date: May 1999
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy
• Neurologic Manifestations

Intervention

Device:
• intraoperative infrared (IR) neuroimaging

Locations

Country	Name	City	State
United States	National Institute of Neurological Disorders and Stroke (NINDS)	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation