Using Electrocorticogram (ECoG) in Predicting Eloquent Cortex and Post-Op Functional Outcomes in Patients With Brain Tumors
| Status: | Recruiting |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/3/2018 |
| Start Date: | July 2016 |
| End Date: | July 2019 |
| Contact: | Sujit Prabhu, MD |
| Phone: | 713-792-2400 |
Pilot Investigation of Using Electrocorticogram (ECoG) in Predicting Eloquent Cortex and Post-Operative Functional Outcomes in Patients With Brain Tumors
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.
This is an investigational study. The fMRI, TMS procedure, and direct electrical stimulation
are FDA-approved procedures. Both PMT and AdTech mapping grids are FDA-approved and
commercially available.
ECoG mapping utilizing the PMT grids during brain tumor surgery is FDA-approved and currently
used at MD Anderson. The AdTech grid is FDA-approved and was previously used in MD Anderson.
ECoG mapping utilizing these grids is currently being used for research purposes only.
Up to 10 participants will be enrolled in this study. All will take part at MD Anderson.
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.
This is an investigational study. The fMRI, TMS procedure, and direct electrical stimulation
are FDA-approved procedures. Both PMT and AdTech mapping grids are FDA-approved and
commercially available.
ECoG mapping utilizing the PMT grids during brain tumor surgery is FDA-approved and currently
used at MD Anderson. The AdTech grid is FDA-approved and was previously used in MD Anderson.
ECoG mapping utilizing these grids is currently being used for research purposes only.
Up to 10 participants will be enrolled in this study. All will take part at MD Anderson.
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 three types of high definition mapping grids (PMT,
AdTech 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.
- 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 three types of high definition mapping grids (PMT,
AdTech 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.
Inclusion Criteria:
1. Patients undergoing a tumor resection at the University of Texas M. D. Anderson Cancer
Center for a newly diagnosed primary or metastatic brain tumor located in or adjacent
to motor brain areas.
2. Patients >/= 18 years of age.
3. Signed informed consent.
Exclusion Criteria:
1) Patients with significant neurological motor deficits of the upper extremities, which
would preclude them from performing the while awake intra-operative tasks.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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