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

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02754544
• Collaborator: National Cancer Institute (NCI) (NIH), University of Houston (Other)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 137.3
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Neoplasm; Metastatic Malignant Neoplasm in the Brain; Recurrent Brain Neoplasm	Procedure: Direct Electrocortical Stimulation; Other: Electrocorticography	N/A

Detailed Description

PRIMARY OBJECTIVE:

1. 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:

1. 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.

Study Design

• Study Type: Interventional
• Anticipated 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: Jul 22, 2016
• Anticipated Primary Completion Date: Jan 1, 2027
• Anticipated Study Completion Date: Jan 1, 2028

Arms and Interventions

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 Names: ECoG

Outcome Measures

Primary Outcome Measures

1. Electrocorticogram (ECoG) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M D Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• M.D. Anderson Cancer Center
• National Cancer Institute (NCI)
• University of Houston

Investigators

• Principal Investigator: Sujit S Prabhu, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• MD Anderson Cancer Center Website

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT02754544
• Other Study ID Numbers: 2015-0775; NCI-2016-00794; 2015-0775
• First Posted: Apr 28, 2016
• Last Update Posted: Jun 27, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms; Brain Neoplasms

Study Results

No Results Posted as of Jun 27, 2022