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

Study Purpose

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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


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Study Type
Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT02754544

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
N/A

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
M.D. Anderson Cancer Center

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Sujit Prabhu, MD
Principal Investigator Affiliation M.D. Anderson Cancer Center

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Other
Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Brain Tumor
Study Website: View Trial Website
Additional Details

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.

Contact a Trial Team

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Houston, Texas

Status

Recruiting

Address

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

Site Contact

713-792-2400

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