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

Metastatic Malignant Neoplasm in the Brain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02754544
• Other study ID #: 2015-0775
• Secondary ID: NCI-2016-0079420
• Status: Recruiting
• Phase: N/A
• Start date: July 22, 2016
• Est. completion date: January 1, 2028

Study information

• Verified date: November 2023
• Source: M.D. Anderson Cancer Center
• Contact: Sujit Prabhu, MD
• Phone: 713-792-2400
• Email: sprabhu[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: January 1, 2028
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasm
• Brain Neoplasms
• Metastatic Malignant Neoplasm in the Brain
• Neoplasms
• Recurrent Brain Neoplasm

Intervention

Procedure:
• Direct Electrocortical Stimulation
Undergo direct electrocortical stimulation

Other:
• Electrocorticography
Undergo electrocorticography

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI), University of Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electrocorticogram (ECoG)	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.	Up to 1 year

External Links

•   MD Anderson Cancer Center Website