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临床试验/NCT04163315
NCT04163315进行中(未招募)不适用

Multimodal Connectome Study of Brain Tumor-operated Patients

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年12月12日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
30
试验地点
2
主要终点
Correlations between tumor topography, cortical electrical conduction rates measured in electrocorticography, and microstructural measurements of white substance from diffusion MRI

研究概览

简要总结

In this pilot study, the investigators propose a multimodal evaluation of the brain connectivity of brain tumor patients, in order to better understand the effects induced by focal lesions on brain structure and function, as well as brain plasticity mechanisms that may occur in such condition. The investigators aim at drawing a multimodal brain connectivity map of focally brain-damaged patients, with a view to improve onco-functional neurosurgical practices.

详细描述

Patients included in the present study will first perform the pre-operative MRI (dMRI and fMRI) with a specific High Resolution Angular Diffusion (HARDI) sequence and a functional acquisition at rest. Then, the investigators will record their cortico-cortical evoked potentials elicited by direct electrostimulation during the surgery, just before the tumor removal, following our usual protocol. Finally, all data (clinical, diffusion, electrical and functional connectivity) will be processed and correlated to each other.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients with brain tumor for removal
  • Age > 18 years
  • Informed patient consent
  • Membership of social security scheme

排除标准

  • Contraindication to MRI
  • Any subject with vascular stent implanted less than 6 weeks prior to the exam;
  • Any subject carrying an intraocular or intracranial ferromagnetic foreign object close to nerve structures;
  • Any subject carrying biomedical equipment such as a cardiac, neuronal or sensory pacemaker (cochlear implant) or a ventricular bypass valve without medical and paramedical supervision trained in the performance of MRI in these subjects;
  • Presence of more than one brain tumor
  • Refusal of patient participation
  • Pregnant or nursing women. A urinary pregnancy test will be conducted for women of childbearing age. The results will be communicated to the patient by a doctor of her choice.
  • Person staying in a health or social establishment
  • Person in emergency situation
  • Vulnerable patient: deprived of liberty, guardianship, curators, or safeguarding of justice

结局指标

主要结局

Correlations between tumor topography, cortical electrical conduction rates measured in electrocorticography, and microstructural measurements of white substance from diffusion MRI

时间窗: 1 month

次要结局

  • Correlations between neurological disorders, tumor topography and network disruption identified in functional rest MRI(1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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