跳至主要内容
临床试验/NCT05373394
NCT05373394已完成不适用

Evaluation of Cognitive and Motor Neurological Disorders in the Short and Long Term After Surgery for the Removal of a Diffuse Low-grade Glioma of the Supplementary Motor Area

University Hospital, Tours1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2022年5月19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
22
试验地点
1
主要终点
motor tests in the case group - 400 point assessment

研究概览

简要总结

Background : The supplementary motor area is the most common/preferential brain location of LGG. This area plays an important role in many motor and cognitive functions such as motor initiation, bimanual coordination and executive functions. Many studies describe the supplementary motor area syndrome resulting from lesions in this area. News managements for LGGs consisting in intraoperative mapping in awake patients reduce significantly neurological disorders and increase also the overall survival . However, the literature does not provide data concerning motor and cognitive functions in a long term and their consequences in the quality of life of patients.

Objective : The aim of our research project is to identify whether there are some motor or neurocognitive deficit in the short and the long term in a population of patients who have medical story of LGG resection in the supplementary motor area.

详细描述

Patients and Methods : 20 patients who have medical story of LGG in the supplementary motor area and 20 patients who have medical story of LGG resection in other locations are recruited. Firstly, patients have to complete a self-assessment questionnaire about their quality of life, sent by regular mail or e-mail. Then, patients are admitted on the same day as their follow up visit and underwent motor and neurocognitive screening tests ( "Bilan des 400 points", Tests of Attentional Performances) for an hour. The investigators will analyse data and compare between the 2 groups.

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

入选标准

  • 18 years of age or older
  • Have a history of low-grade diffuse glioma resection
  • Visiting the University Hospital for a follow-up neurosurgical consultation
  • Underwent awake surgery

排除标准

  • Presence of cognitive disorders that do not allow the proposed test battery to be performed
  • Under guardianship or curatorship
  • Opposition to the participation to the research

结局指标

主要结局

motor tests in the case group - 400 point assessment

时间窗: inclusion visit

analysis of the scores obtained at the tests 4 tests : * Hand mobility * Grip strength * Single-handed grasp and movement of objects * Two-handed grasp and movement of objects Minimum value = 0 Maximum value = 100 100/100 means that the various tests regain good motor skills and hand grasp

neuropsychological tests in the case group

时间窗: inclusion visit

analysis of the scores obtained Phase alert system * Reaction time (RT) and standard deviation (SD) measurement with horn * Measurement of reaction times (RT) and standard deviation(SD) without horn * Measurement of the phase alert index Flexibility * Measurement of reaction times (RT) and standard deviation (SD) with hand change * Measurement of reaction times (RT) and standard deviation (SD) without hand change * Overall performance index * Speed accuracy trade off index * Number of wrong answers Incompatibility * Measurement of reaction times (RT) and standard deviation (SD) in compatible condition * Measurement of reaction times (RT) and standard deviation (SD) in incompatible condition * F (visual field) * F (hand) * F (incompatibility: fields \* hand) * Number of false responses RT min : 0 SD min : 0 No maximum value: calculation against standard values

次要结局

  • fatigue self-questionnaire carried out at home : fatigue Impact Scale (FIS)(inclusion visit)
  • Brain MRI(inclusion visit)
  • quality of life self-questionnaire carried out at home : sickness Impact Profile(inclusion visit)
  • motor tests in the control group - 400 point assessment(inclusion visit)
  • neuropsychological tests in the control group(inclusion visit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验