Pilot Investigation of Using Electrocorticogram (ECoG) in Predicting Eloquent Cortex and Post-Operative Functional Outcomes in Patients With Brain Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Electrocorticogram (ECoG)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
No Data Available
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Direct Electrocortical Stimulation (Procedure)
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.
干预措施: Electrocorticography (Other)
结局指标
主要结局
Electrocorticogram (ECoG)
时间窗: 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.
次要结局
未报告次要终点