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临床试验/NCT02391493
NCT02391493已完成不适用

Neural Correlates of Language Control in Bilinguals. Functional MRI and Stimulation Mapping Data in Awake Surgery. (NEUROSWITCH)

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2014年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Brain activity

研究概览

简要总结

For bilingual and multilingual patients, brain activation and Electric Stimulation Mapping studies have shown that different languages may be localized, at least partially, in distinct microanatomical systems located within the same gross anatomical areas.

The present investigation involves both types of healthy bilinguals with carefully controlled proficiency levels, as well as bilingual patients suffering from low-grade glioma.

Functional magnetic resonance imaging data will be collected while the participants perform a picture naming task in blocked conditions for both languages (either English or French) or in switch condition (English and French). A stimulation mapping study will be conducted in the patients during awake surgery with the same tasks.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
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
是

入选标准

  • •Bilingual patients with a pathology indicating an intervention in awake surgery (e.g. low-grade glioma)
  • •At least C1-level of the CECR in both languages
  • •At least 12 years of schooling (French BAC)
  • •Right-handed (Edinburgh test, 1971)
  • •Performance indicator Eastern Cooperative Oncology Group 0-2 (cf. annexe)
  • •Life expectation > 6 month
  • •Affiliated to social insurance
  • •Having given informed consent
  • •Healthy volunteers:
  • •French-English or English-French bilinguals with at least a C1 level (CECR) in both languages
  • •At least 12 years of schooling (French BAC)
  • •Right-handed (Edinburgh test, 1971)
  • •Early bilinguals: age of acquisition of both languages < 3 years
  • •Late bilinguals: age of acquisition of the L2 > 10 years

排除标准

  • •Contra-indication for MRI
  • •Left-handed or ambidexter (less than +80 at the Edinburgh test - 1971)
  • •Mini-Mental State Examination <26
  • •Patient who cannot respect the procedures, visits, exams described in the protocol
  • •Any other medical or psychiatric affection which renders inclusion of the patient to the study inappropriate as judged by the principal investigator
  • •Healthy volunteers:
  • •Contra-indication for MRI
  • •Mini-Mental State Examination < 26
  • •Age of acquisition of one of the language between 3 and 10 years

研究组 & 干预措施

healthy early bilinguals

Experimental

healthy early bilinguals functional magnetic resonance imaging

干预措施: functional magnetic resonance imaging (Device)

healthy late bilinguals

Experimental

healthy late bilinguals functional magnetic resonance imaging

干预措施: functional magnetic resonance imaging (Device)

bilingual patients

Experimental

bilingual patients suffering from low-grade glioma in the language areas functional magnetic resonance imaging

干预措施: functional magnetic resonance imaging (Device)

结局指标

主要结局

Brain activity

时间窗: 24 hours

The primary judgment criteria is brain activity as measured by functional magnetic resonance imaging : * In blocked vs. switched naming in control subjects * In switched naming in early vs. late bilingual subjects * In blocked vs. switched naming in early vs. late bilingual subjects

次要结局

  • Brain activity(24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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