Clinical trial NCT02754544: Electrocorticography in Mapping Functional Brain Areas During Surgery in Patients With Brain Tumors
Official title: Pilot Investigation of Using Electrocorticogram (ECoG) in Predicting Eloquent Cortex and Post-Operative Functional Outcomes in Patients With Brain Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Neoplasm
Metastatic Malignant Neoplasm in the Brain
Recurrent Brain Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: University of Houston
First posted: 2016-04-28
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Electrocorticogram (ECoG)
timeFrame: Up to 6 months (± 4 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Sujit S Prabhu
role: PRINCIPAL_INVESTIGATOR
References: