Assessment of Reorganization and Plasticity of Eloquent Function 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
- 1
- 主要终点
- Eloquent function
研究概览
简要总结
Purpose of the study:
AIM 1: Prospectively collect pre-operative [functional magnetic resonance imaging (fMRI), diffusion tensor imaging (DTI), magnetoencephalography (MEG)] and intra-operative mapping data in patients with intra-axial brain tumors to assess how well each modality predicts the location of eloquent brain function. In addition, each modality will be compared with the other.
AIM 2: Assess reorganization of eloquent brain function and plasticity in patients with intra-axial brain tumors. This will be accomplished by prospectively collecting post-operative mapping studies and neuropsychological tests to compare them to prior mapping studies as stated above.
详细描述
Any patient with a primary or metastatic brain tumor in or near an eloquent area would be eligible for participation in the study assuming no contraindications to any of the studies or operative procedure.
Pre-operative evaluation will include clinical evaluation, neuropsychological testing, magnetic resonance imaging (MRI) brain with and without contrast, fMRI, DTI tractograms, and MEG studies as well as standard pre-operative work-up.
Intra-operative procedures include all non-invasive pre-operative mapping data being incorporated into the operative procedure with imaging tools that are routinely used during neurosurgical procedures. Participants will have awake mapping performed. Usual standards of care will be followed during craniotomy, mapping, and tumor resection or biopsy.
Post-operative procedures include routine post-operative care and assessment consisting of clinical examinations and imaging obtained within 24 hours post-resection. Participants will have routine follow-up outpatient appointments after surgery which will include neurologic assessment and follow-up imaging (MRI with and without contrast) for their tumors as appropriate. The experimental portion of the protocol is incorporating repeat neuropsychological testing and mapping studies (fMRI, DTI, MEG) studies at 2 and 6 months post-surgery into their routine follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19 years and older
- •Brain tumor in or near eloquent brain regions that is appropriate for attempted resection
- •Appropriate body habitus and mental status/capacity to participate with non-invasive or invasive mapping
- •Benign or malignant intra-axial brain tumor
- •Primary or metastatic intra-axial brain tumor
排除标准
- •Any contraindication to MRI (i.e. implanted devices)
- •Inappropriate body habitus or mental status/capacity to participate with non-invasive or invasive mapping in a safe and reliable manner
- •Declining to participate
- •Lacks capacity to understand the study or consent for themselves
- •Neurologic status which precludes testing (poor function- not testable)
- •Positive pregnancy test
- •End stage renal disease or severe renal dysfunction
研究组 & 干预措施
Eloquent area tumor
Standard of care with brain mapping, pre-, intra-, and post-operative.
干预措施: Brain mapping (Diagnostic Test)
结局指标
主要结局
Eloquent function
时间窗: 1 year
The location of the eloquent function of interest (motor, sensory, speech) will be assessed pre-operatively and intra-operatively and compared. Then, at 2 and 6 months post-operatively, repeat non-invasive mapping studies will be performed to compare to the subjects' prior studies. This will allow for assessment of reorganization and plasticity of function. Additionally, novel ways of identifying eloquent brain regions will be developed.
次要结局
未报告次要终点