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

Not Applicable

Recruiting

• Conditions: Recurrent Brain Neoplasm; Brain Neoplasm; Metastatic Malignant Neoplasm in the Brain
• Interventions: Procedure: Direct Electrocortical Stimulation; Other: Electrocorticography

• Registration Number: NCT02754544
• Lead Sponsor: 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.

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 and language/speech deficits in the short term (24 hours) and long-term (1, 3, and 6 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, 3, and 6 months.

Study Timeline

• Study First Submitted: 2016-04-25
• Study First Submitted QC: 2016-04-25
• Study First Posted: 2016-04-28
• Study Start: 2016-07-22
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-18
• Primary Completion: 2027-01-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (electrocorticography)	Direct Electrocortical Stimulation	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.
Diagnostic (electrocorticography)	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.

Primary Outcome Measures

Name	Time	Method
Electrocorticogram (ECoG)	Up to 6 months (± 4 weeks)	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 and language/speech outcome. The Chi-square or Fisher's exact tests will be used to explore associations between categorical variables. Additional analysis may be performed.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States