Pilot Study: Functional Imaging of Cerebellar Mutism Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- investigate the feasibility of performing preoperative fMRI
研究概览
简要总结
The purpose of this study is to better understand why some children with cancer have difficulty speaking after brain surgery. Difficulty speaking may be due to known complications to the language centers in the brain. These language centers may be located in slightly different places in different people. This study will study which areas may be damaged.
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
- 3 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject and/or guardian is able to provide written informed consent prior to study registration
- •Age ≥3 years and ≤21 years
- •Newly diagnosed, untreated mass in posterior fossa, either benign or malignant
- •Is being evaluated for surgical resection of the mass
- •Able to perform clinical language testing in English
排除标准
- •Claustrophobia
- •Any contraindication to MRI (e.g., pacemaker, aneurysm clip, tissue expander).
- •Pregnant or nursing female
- •Does not speak English as a primary language (as determined by the P.I. or treating physician after discussion with a potential subject and his/her family)
- •Preexisting language or developmental disorder that would limit ability to cooperate with testing (as determined by the P.I. or treating physician after interviewing potential subject and his/her family; for example, a child may be excluded if he/she has confirmed or suspected autism spectrum disorder, dysarthria, dyslexia, lisp, hypotonia, or other age inappropriate speech development)
结局指标
主要结局
investigate the feasibility of performing preoperative fMRI
时间窗: 1 year
in young children at risk for developing CMS after posterior fossa brain tumor resection. Age appropriate language functional MRI tasks targeting the cerebellar language centers will be performed in children before surgery and correlated with formal neuropsychological and language testing. The fMRI will be repeated after surgery. If ≥5 of the 7 subjects successfully complete ≥60% of the functional imaging tests, we will determine the pilot study to be successful and then pursue further study.
次要结局
- To investigate potential changes in Diffusion Tensor Imaging (DTI) and tractography(1 year)
- To investigate potential changes in DTI after posterior fossa surgery(1 year)