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临床试验/NCT04536142
NCT04536142已完成不适用

Evaluation of Changes in Brain Connectivity After Tumor Resection

University of Nebraska1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2020年8月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
1
主要终点
Brain connectivity changes

研究概览

简要总结

This study is being done to see the changes in structural and functional connectivity that happen in the brain of patients undergoing brain tumor surgery.

详细描述

The purpose of this study is to visualize and quantify changes in the brain of patients undergoing brain tumor surgery through high-quality, high-resolution structural and functional brain imaging and brain connectivity measures. To understand the effects of the primary treatment for brain tumors, the investigators will determine changes in brain connectivity after surgery and correlate this with neurologic status. The investigators will prospectively collect brain imaging (MRI) and clinical data in brain tumor patients before and after removal of their tumor. Any adult patient with a brain tumor (primary or metastatic) for whom surgery to remove the tumor is planned is eligible. The investigators plan for recruitment of 30 subjects. This will include 27 subjects with brain tumors and 3 healthy controls. Both clinical and imaging data will be collected for tumor and healthy subjects. A two-part research scan (diffusion MRI and resting state functional MRI) will be performed within 1 week prior to surgery and again 2 weeks after surgery. The healthy controls will obtain identical research scans with the second session two weeks following the first session. Subjects will be also administered Neurocognitive and Qualitative Assessments at two time intervals, pre- and post-surgery (2 weeks).

研究设计

研究类型
Observational
观察模型
Case Control
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

入选标准

  • Brain tumor subjects (27)
  • informed consent
  • age equal to or greater than 19 years (age of majority in Nebraska)
  • brain tumor that requires surgery
  • primary or metastatic brain tumor
  • Healthy subjects (3)
  • informed consent
  • age equal to or greater than 19 years (age of majority in Nebraska)
  • healthy subject with no know neurocognitive deficiencies

排除标准

  • any contraindication to MRI (i.e. implanted devices)
  • inappropriate body habitus for MRI
  • no capacity to understand the study the study or consent to it
  • positive pregnancy test in females
  • end stage renal disease or severe renal dysfunction
  • severe anxiety disorder
  • metabolic encephalopathy
  • significant medical co-morbidities precluding a safe surgery
  • need for sedation for MRI

结局指标

主要结局

Brain connectivity changes

时间窗: MRI scan will be performed within 1 week prior to surgery and again 2 weeks after surgery.

With both the functional and structural connectomes created, the investigators will compute graph network measures before and after surgical resection and assess both nodal and global network measures.

Neurocognitive changes

时间窗: Cognitive tests will be performed within 1 week prior to surgery and again 2 weeks after surgery.

Meyers Neuropsychological Battery: Published reliable change indices (RCI) will be used to control for practice effects between the assessment points for all Meyers Neuropsychological Battery (MNB) subtests. QOL inventories: Differences in scores at baseline, relative to treatment phase, will be calculated.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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