Electrocorticography in Mapping Functional Brain Areas During Surgery in Patients With Brain Tumors
Primary Purpose
Brain Neoplasm, Metastatic Malignant Neoplasm in the Brain, Recurrent Brain Neoplasm
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Direct Electrocortical Stimulation
Electrocorticography
Sponsored by
About this trial
This is an interventional diagnostic trial for Brain Neoplasm
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing a tumor resection at the University of Texas M. D. Anderson Cancer Center for a newly diagnosed as well as recurrent primary or metastatic brain tumor located in or adjacent to motor and/or speech brain areas
- Patients >= 18 years of age
- Signed informed consent
Exclusion Criteria:
- Patients with significant neurological motor deficits of the upper extremities, and/or speech deficits, which would preclude them from performing the while awake intra-operative tasks at the discretion of the principal investigator (PI)
- Patients who have impaired vision and/or hearing and whose performance could affect the study will be excluded at the discretion of the PI
Sites / Locations
- M D Anderson Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diagnostic (electrocorticography)
Arm Description
Patients undergo tumor resection. During surgery, patients also undergo electrocorticography with either the CorTec high resolution hybrid grid, the PMT high-resolution grid, or the Ad-Tech grid followed by direct electrocortical stimulation.
Outcomes
Primary Outcome Measures
Electrocorticogram (ECoG)
Will be assessed by cortical electrical activity based on individual hand muscle function. ECoG will be compared to direct electrical stimulation (DES), navigated transcranial magnetic stimulation (nTMS), and functional magnetic resonance imaging (fMRI). The data obtained using ECoG will be correlated with the fMRI and TMS data acquired preoperatively and intraoperative DES. The categorical variables would be preoperative Karnofsky performance status and functional status, tumor location, fMRI, TMS, ECoG, and DES data points. Other variables involved in the analysis would be extent of resection and neurological outcome. The Chi-square or Fisher's exact tests will be used to explore associations between categorical variables. Additional analysis may be performed.
Secondary Outcome Measures
Full Information
NCT ID
NCT02754544
First Posted
April 25, 2016
Last Updated
August 17, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI), University of Houston
1. Study Identification
Unique Protocol Identification Number
NCT02754544
Brief Title
Electrocorticography in Mapping Functional Brain Areas During Surgery in Patients With Brain Tumors
Official Title
Pilot Investigation of Using Electrocorticogram (ECoG) in Predicting Eloquent Cortex and Post-Operative Functional Outcomes in Patients With Brain Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 22, 2016 (Actual)
Primary Completion Date
January 1, 2027 (Anticipated)
Study Completion Date
January 1, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI), University of Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This pilot clinical trial studies how well electrocorticography works in mapping functional brain areas during surgery in patients with brain tumors. Using a larger than the standard mapping grid currently used during brain tumor surgery or a high-definition grid for electrocorticogram brain mapping may help doctors to better identify which areas of the brain are active during specific limb movement and speech during surgery in patients with brain tumors.
Detailed Description
PRIMARY OBJECTIVE:
I. To record electrocorticogram (ECoG) data intraoperatively with surface electrode grids during various motor, sensory (tactile) and speech tasks, and identify functional brain areas through the spectral analysis, and compare the preliminary data with our current pre-surgical mapping methods: functional magnetic resonance imaging (fMRI) and transcranial magnetic stimulation (TMS), and the gold standard, intraoperative direct electrical stimulation (DES).
SECONDARY OBJECTIVE:
I. To perform a preliminary assessment of the utility of using ECoG data in these patients to quantify new neurological deficits in the short term (24 hours) and long-term (1 and 3 months), and achieve a safe maximal tumor resection.
OUTLINE:
Patients undergo tumor resection. During surgery, patients also undergo electrocorticography with either the CorTec high resolution hybrid grid, the PMT high-resolution grid, or the Ad-Tech grid followed by direct electrocortical stimulation.
Following completion of study, patients are followed up within 24 hours from surgery and at 1 and 3 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Neoplasm, Metastatic Malignant Neoplasm in the Brain, Recurrent Brain Neoplasm
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic (electrocorticography)
Arm Type
Experimental
Arm Description
Patients undergo tumor resection. During surgery, patients also undergo electrocorticography with either the CorTec high resolution hybrid grid, the PMT high-resolution grid, or the Ad-Tech grid followed by direct electrocortical stimulation.
Intervention Type
Procedure
Intervention Name(s)
Direct Electrocortical Stimulation
Other Intervention Name(s)
DCES, Direct Cortical Electrical Stimulation, Electrocortical Stimulation Mapping, ESM
Intervention Description
Undergo direct electrocortical stimulation
Intervention Type
Other
Intervention Name(s)
Electrocorticography
Other Intervention Name(s)
ECoG
Intervention Description
Undergo electrocorticography
Primary Outcome Measure Information:
Title
Electrocorticogram (ECoG)
Description
Will be assessed by cortical electrical activity based on individual hand muscle function. ECoG will be compared to direct electrical stimulation (DES), navigated transcranial magnetic stimulation (nTMS), and functional magnetic resonance imaging (fMRI). The data obtained using ECoG will be correlated with the fMRI and TMS data acquired preoperatively and intraoperative DES. The categorical variables would be preoperative Karnofsky performance status and functional status, tumor location, fMRI, TMS, ECoG, and DES data points. Other variables involved in the analysis would be extent of resection and neurological outcome. The Chi-square or Fisher's exact tests will be used to explore associations between categorical variables. Additional analysis may be performed.
Time Frame
Up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing a tumor resection at the University of Texas M. D. Anderson Cancer Center for a newly diagnosed as well as recurrent primary or metastatic brain tumor located in or adjacent to motor and/or speech brain areas
Patients >= 18 years of age
Signed informed consent
Exclusion Criteria:
Patients with significant neurological motor deficits of the upper extremities, and/or speech deficits, which would preclude them from performing the while awake intra-operative tasks at the discretion of the principal investigator (PI)
Patients who have impaired vision and/or hearing and whose performance could affect the study will be excluded at the discretion of the PI
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sujit Prabhu, MD
Phone
713-792-2400
Email
sprabhu@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sujit S Prabhu
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sujit S. Prabhu
Phone
713-792-2400
Email
sprabhu@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Sujit S. Prabhu
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website
Learn more about this trial
Electrocorticography in Mapping Functional Brain Areas During Surgery in Patients With Brain Tumors
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