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NCT Number: NCT02754544

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Sujit S. Prabhu

CONTACT

[email protected]

713-792-2400

Sujit S. Prabhu

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Direct Electrocortical Stimulation

Procedure

Undergo direct electrocortical stimulation

Other names: DCES, Direct Cortical Electrical Stimulation, Electrocortical Stimulation Mapping, ESM

Electrocorticography

Other

Undergo electrocorticography

Other names: ECoG

Primary outcomes

  1. Electrocorticogram (ECoG)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sujit Prabhu, MD

CONTACT

[email protected]

713-792-2400

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)
  • University of Houston

Registry information

Official study title

Pilot Investigation of Using Electrocorticogram (ECoG) in Predicting Eloquent Cortex and Post-Operative Functional Outcomes in Patients With Brain Tumors

Important dates

Study start
2016
Primary completion
2027
Study completion
2028
First posted
Apr 28, 2016
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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