ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02754544
Recruitment Status : Recruiting
First Posted : April 28, 2016
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Brain Tumor Procedure: Electrocorticography (ECoG) with PMT Grids Procedure: Electrocorticography (ECoG) with CorTec Grids Procedure: Digital Glove Procedure Procedure: Neurological Exam Procedure: Electrocorticography (ECoG) with Ad-Tech Grids Procedure: Direct Electrical Stimulation Mapping Procedure: Grip Sensor Procedure Not Applicable

Detailed 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 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pilot Investigation of Using Electrocorticogram (ECoG) in Predicting Eloquent Cortex and Post-Operative Functional Outcomes in Patients With Brain Tumors
Actual Study Start Date : July 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arm Intervention/treatment
Experimental: PMT High-Resolution Grid Group
Electrocorticography (ECoG) mapping takes place during participant's scheduled surgery. PMT High-Resolution Grids with fixed contact diameter used during ECoG. Mapping grid placed directly on the surface of participant's brain during surgery. A wireless digital glove used with the high-definition grid. When the grid is in place, the anesthesiologist will wake participant up and they will be asked to wear the special glove and perform hand movements. Continuous hand grasp force levels and resting state measured with a grip sensor during surgery. Direct electrical stimulation mapping performed by neurosurgeon during surgery. Neurological exam performed one day after surgery.
Procedure: Electrocorticography (ECoG) with PMT Grids
Electrocorticography (ECoG) mapping takes place during participant's scheduled surgery. PMT grids with fixed contact diameter used during ECoG.

Procedure: Digital Glove Procedure
When grid is in place, participant awakened and asked to wear digital glove and perform hand movements. This should take about 20 minutes.

Procedure: Neurological Exam
Neurological exam (tests to check the functioning of participant's nerves, including tests of their balance and reflexes) performed one day after surgery. Exam also performed at 1 and 3 months after surgery.

Procedure: Direct Electrical Stimulation Mapping
During surgery neurosurgeon performs standard tests to learn which parts of the brain near the tumor control the arms and legs. These areas of the brain stimulated with a small-dose electrical current to see which limbs will move.

Procedure: Grip Sensor Procedure
Continuous grasp force levels and resting state measured with a grip sensor. Participants asked to grasp and squeeze the force sensor for 2-3 sec for 30 trials.

Experimental: CorTec High-Resolution Hybrid Grid Group
Electrocorticography (ECoG) mapping takes place during participant's scheduled surgery. CorTec High-Resolution Hybrid Grids with fixed contact diameter used during ECoG. Mapping grid placed directly on the surface of participant's brain during surgery. A wireless digital glove used with the high-definition grid. When the grid is in place, the anesthesiologist will wake participant up and they will be asked to wear the special glove and perform hand movements.Continuous hand grasp force levels and resting state measured with a grip sensor during surgery. Direct electrical stimulation mapping performed by neurosurgeon during surgery. Neurological exam performed one day after surgery.
Procedure: Electrocorticography (ECoG) with CorTec Grids
Electrocorticography (ECoG) mapping takes place during participant's scheduled surgery. CorTec high resolution hybrid grids used during ECoG.

Procedure: Digital Glove Procedure
When grid is in place, participant awakened and asked to wear digital glove and perform hand movements. This should take about 20 minutes.

Procedure: Neurological Exam
Neurological exam (tests to check the functioning of participant's nerves, including tests of their balance and reflexes) performed one day after surgery. Exam also performed at 1 and 3 months after surgery.

Procedure: Direct Electrical Stimulation Mapping
During surgery neurosurgeon performs standard tests to learn which parts of the brain near the tumor control the arms and legs. These areas of the brain stimulated with a small-dose electrical current to see which limbs will move.

Procedure: Grip Sensor Procedure
Continuous grasp force levels and resting state measured with a grip sensor. Participants asked to grasp and squeeze the force sensor for 2-3 sec for 30 trials.

Experimental: Ad-Tech Grid Group
Electrocorticography (ECoG) mapping takes place during participant's scheduled surgery. Ad-Tech Grids with fixed contact diameter used during ECoG. Mapping grid placed directly on the surface of participant's brain during surgery. A wireless digital glove used with the high-definition grid. When the grid is in place, the anesthesiologist will wake participant up and they will be asked to wear the special glove and perform hand movements. Continuous hand grasp force levels and resting state measured with a grip sensor during surgery. Direct electrical stimulation mapping performed by neurosurgeon during surgery. Neurological exam performed one day after surgery.
Procedure: Digital Glove Procedure
When grid is in place, participant awakened and asked to wear digital glove and perform hand movements. This should take about 20 minutes.

Procedure: Neurological Exam
Neurological exam (tests to check the functioning of participant's nerves, including tests of their balance and reflexes) performed one day after surgery. Exam also performed at 1 and 3 months after surgery.

Procedure: Electrocorticography (ECoG) with Ad-Tech Grids
Electrocorticography (ECoG) mapping takes place during participant's scheduled surgery. Ad-Tech Grids used during ECoG.

Procedure: Direct Electrical Stimulation Mapping
During surgery neurosurgeon performs standard tests to learn which parts of the brain near the tumor control the arms and legs. These areas of the brain stimulated with a small-dose electrical current to see which limbs will move.

Procedure: Grip Sensor Procedure
Continuous grasp force levels and resting state measured with a grip sensor. Participants asked to grasp and squeeze the force sensor for 2-3 sec for 30 trials.




Primary Outcome Measures :
  1. Comparison of the Electrocorticogram (ECoG) Data to Standard Mapping During Brain Surgery Using PMT High-Resolution Grids, CorTec High Density Grids or Ad-Tech Grids [ Time Frame: 3 months ]
    Data for comparison obtained using ECoG correlated with the functional MRI (fMRI) and transcranial magnetic stimulation (TMS). Data acquired preoperatively and intraoperatively using direct electrical stimulation (DES).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02754544


Contacts
Contact: Sujit Prabhu, MD 713-792-2400

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Sujit Prabhu, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02754544     History of Changes
Other Study ID Numbers: 2015-0775
NCI-2016-00794 ( Registry Identifier: NCI CTRP )
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No

Keywords provided by M.D. Anderson Cancer Center:
Brain tumor
Metastatic brain tumor
Neurosurgery
Electrocorticogram
ECoG
Transcranial magnetic stimulation
TMS
Direct electrical stimulation
DES
Functional MRI
fMRI
PMT High-Resolution Grids
CorTec High-Resolution Hybrid Grids
Digital glove
Neurological exam
Ad-Tech Grids
Grip Sensor

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases