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Using Electrocorticogram (ECoG) in Predicting Eloquent Cortex and Post-Op Functional Outcomes in Patients With Brain Tumors

2016-05-01 21:47:15 | BioPortfolio

Summary

The goal of this clinical research study is to learn if using a larger than the standard mapping grid currently used at MD Anderson during brain tumor surgery or a high-definition grid for electrocorticogram (ECoG) brain mapping can help better identify which areas of the brain are active during specific limb movement and speech. In this study, the result of two types of ECoG mapping grids will be analyzed.

ECoG mapping will take place during your scheduled surgery. Before the procedure, you will be assigned one of the two types of mapping grids. The mapping grid will be placed directly on the surface of your brain during surgery. You will not be able to feel this. The grids contain electrodes attached to a computer to record brain activity. A wireless digital glove will be used with the high-definition grid. The glove records hand movements, while the grids shows the areas of the brain that are active during the hand movements.

Description

Before surgery:

- You will have 2 standard pre-surgical brain mapping procedures: functional magnetic resonance imaging (fMRI) and transcranial magnetic stimulation (TMS). For the fMRI, you will lie inside of a long scanner and be asked to perform several simple tasks. The scan will show areas of the brain that are active during specific tasks. During the TMS procedure, a magnetic coil is moved over certain areas of your head to stimulate the parts of the brain that cause muscles in your arms and legs to move. This will help the doctor learn which specific parts of your brain control your limbs.

- You will be trained to use the wireless digital glove that will be used in the ECoG mapping during your surgery.

- You will be assigned one of the two types of mapping grids (PMT grid or CorTec grid) to be used during your surgery.

During surgery:

- The mapping grid will be placed on the surface of your brain.

- When the grid is in place, the anesthesiologist will wake you up and you will be asked to wear the special glove and perform hand movements. This should take about 20 minutes.

- The neurosurgeon will perform standard tests (direct electrical stimulation mapping) to learn which parts of the brain near the tumor control the arms and legs. These areas of the brain will be stimulated with a small-dose electrical current to see which limbs will move.

- After this procedure, the anesthesiologist will put you back to sleep.

The results of the ECoG mapping will be used for research purposes only. They will not be used to make decisions about your surgery. The collected data will be de-identified and will be transferred to neural engineering laboratory of Dr. Ince located at the University of Houston for detailed computer based analysis.

One (1) day after surgery, you will have a neurological exam (tests to check the functioning of your nerves, including tests of your balance and reflexes).

Length of Study:

Your participation on the study will be over after the follow-up visits.

Follow-up Visits:

At 1 and 3 months after your surgery, you will come back to the clinic for standard follow-up visits. At each visit, you will have a complete physical and neurological exam.

This is an investigational study. The fMRI, TMS procedure, and direct electrical stimulation are FDA-approved procedures. PMT mapping grids are FDA-approved and commercially available.

ECoG mapping utilizing the PMT grid during brain tumor surgery is FDA-approved and currently used at MD Anderson. ECoG mapping utilizing the CorTec high-resolution hybrid grid is currently being used for research purposes only.

Up to 20 participants will be enrolled in this study. 15 participants will be assigned the PMT high-resolution grid and 5 will be assigned the CorTec high-resolution hybrid grid. All will take part at MD Anderson.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Conditions

Brain Tumor

Intervention

Electrocorticography (ECoG) with PMT Grids, Electrocorticography (ECoG) with CorTec Grids, Digital Glove Procedure, Neurological Exam

Location

University of Texas MD Anderson Cancer Center
Houston
Texas
United States
77030

Status

Not yet recruiting

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-05-01T21:47:15-0400

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