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临床试验/NCT00632437
NCT00632437撤回不适用

Intraoperative Optical Imaging of Brain Function

M.D. Anderson Cancer Center1 个研究点 分布在 1 个国家开始时间: 2008年2月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Test performance of novel optical imaging system for real-time quantitative imaging of brain function through multiple hemodynamic measures during neurosurgery

研究概览

简要总结

The goal of this proposal is to test the performance of a novel optical imaging system for real-time quantitative imaging of brain function through multiple hemodynamic measures during neurosurgery.

This pilot study encompasses two sub-aims:

  • Evaluate the ability of laser speckle contrast imaging to image cerebral blood flow (CBF) intraoperatively. We will image the changes in CBF in response to somatosensory stimulation. (5 patients).
  • Simultaneously image hemoglobin oxygenation, blood volume, blood flow, and cerebral metabolic rate of oxygen (CMRO2) changes during somatosensory stimulation using a combined laser speckle and multi-wavelength reflectance imaging system. (5 patients).

详细描述

A speckle-contrast imaging camera uses a low-power laser to check brain activity. The imaging camera uses reflected red light to take a special kind of picture of the amount of blood flowing in your brain, and the amount of oxygen in your blood. This is the first time this device has been used in brain surgery.

While "asleep" under anesthesia during an already scheduled surgery, the neurosurgeon will position the microscope to take pictures of the surgery area. The pictures will be taken after the brain is exposed, but before the rest of the surgery takes place. Researchers will shine the red light onto the brain during your surgery. The light will then be seen by the camera.

"Cortical mapping" will done, which is an established procedure used to detect important areas of the brain. Usually, a nerve in the wrist is stimulated with a very small shock of electricity and a response is detected in the brain by an electrode placed on the surface. The electrical shock administered is not dangerous or painful. It will be given while "asleep." For the experimental procedure used in this study, the same stimulation will be used, but the impulse detection will be performed using the speckle-contrast imaging camera. Researchers hope to see if the change in blood flow gives the same information as if the electrode was placed on the brain and used to detect the electricity. Doing both procedures is expected to take no more than 20 minutes. During this time, continual monitoring done by the surgeon and operating room staff.

Your participation in this study will end when the surgery is finished.

The results of this study will not be used by the surgeon during your surgery or any future treatments. These measurements are being done for research only and will not be used by the surgeon to make any decisions about your surgery.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Location of planned resection near somatosensory cortex.
  • Planned intraoperative electrocortical mapping.
  • Able to render written informed consent.

排除标准

  • Patients with a hemiparesis graded 3/5 (active movement against gravity) or worse. Unpublished data from MDACC Department of Neurosurgery suggests that cortical mapping is ineffective in these patients because an adequate cortical response is not detected
  • Patients with a vascular malformation within the proximity of the cortex area imaged.

结局指标

主要结局

Test performance of novel optical imaging system for real-time quantitative imaging of brain function through multiple hemodynamic measures during neurosurgery

时间窗: 2 Years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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