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Electrocorticography in Mapping Functional Brain Areas During Surgery in Patients With Brain Tumors

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ClinicalTrials.gov Identifier: NCT02754544
Recruitment Status : Recruiting
First Posted : April 28, 2016
Last Update Posted : May 18, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
University of Houston
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Brain Neoplasm Metastatic Malignant Neoplasm in the Brain Recurrent Brain Neoplasm Procedure: Direct Electrocortical Stimulation Other: Electrocorticography Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 22, 2016
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arm Intervention/treatment
Experimental: Diagnostic (electrocorticography)
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.
Procedure: Direct Electrocortical Stimulation
Undergo direct electrocortical stimulation
Other Names:
  • DCES
  • Direct Cortical Electrical Stimulation
  • Electrocortical Stimulation Mapping
  • ESM

Other: Electrocorticography
Undergo electrocorticography
Other Name: ECoG




Primary Outcome Measures :
  1. Electrocorticogram (ECoG) [ Time Frame: Up to 1 year ]
    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.



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

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
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Contact: Sujit Prabhu, MD 713-792-2400 sprabhu@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Sujit S. Prabhu    713-792-2400    sprabhu@mdanderson.org   
Principal Investigator: Sujit S. Prabhu         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
University of Houston
Investigators
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Principal Investigator: Sujit S Prabhu M.D. Anderson Cancer Center
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02754544    
Other Study ID Numbers: 2015-0775
NCI-2016-00794 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2015-0775 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases