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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-22

Study Completion Date

2028-01-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Brain Neoplasm Metastatic Malignant Neoplasm in the Brain Recurrent Brain Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

No Data Available

Study Groups

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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.

Group Type EXPERIMENTAL

Direct Electrocortical Stimulation

Intervention Type PROCEDURE

Undergo direct electrocortical stimulation

Electrocorticography

Intervention Type OTHER

Undergo electrocorticography

Interventions

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Direct Electrocortical Stimulation

Undergo direct electrocortical stimulation

Intervention Type PROCEDURE

Electrocorticography

Undergo electrocorticography

Intervention Type OTHER

Other Intervention Names

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DCES Direct Cortical Electrical Stimulation Electrocortical Stimulation Mapping ESM ECoG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No