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临床试验/NCT04738851
NCT04738851已完成不适用

ARTHEMIRS: Assessment of Brain Activation During Different Mirror Therapy Tasks Using fNIRS Technology

Centre Hospitalier Régional d'Orléans2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2021年2月8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
35
试验地点
2
主要终点
Compare the level of precuneus activation during conventional mirror therapy (TMC) and virtual mirror therapy (TMV)

研究概览

简要总结

The purpose of this study is to investigate the cerebral activation during Classic Mirror Therapy (TMC) and especially during Virtual Mirror Therapy (TMV) in healthy subjects. It seems that the precuneus is involved in the effectiveness of mirror therapy. One goal of this study is to determine if there is a better activation of the precuneus during TMV than during TMC. Others goals are to compare cerebral activation during three different tasks (TMV, TMC and a simple motor task), to study the intra-subjects reproducibility of the measurement and the correlation between cerebral activation and feelings of the participants about the efficacity of the tasks.

详细描述

Mirror therapy is a rehabilitation technique that has been shown to be effective in restoring upper limb motor skills in patients with stroke. However, it comes up against certain constraints of clinical use such as installation difficulties or the obligation of symmetrical bilateral work. These constraints can be limited by the use of so-called 2nd generation virtual mirror therapy technologies. It is therefore likely that these new technologies will improve the feasibility and effectiveness of mirror therapy in rehabilitation. While the brain mechanisms involved in mirror therapy are not yet fully understood, the involvement of the precuneus has been demonstrated by a booming imaging method: fNIRS (functional Near Infra Red Spectroscopy). This method allows (like fMRI) to study cerebral neurovascular coupling. It is based on the fact that an activated region of the brain increases its local blood flow. Oxygenated hemoglobin (HbO) and deoxygenated (HbR) absorb infrared light and it is then possible to identify the cortical regions of the brain involved in a given task. This technique therefore makes it possible to study brain activation under more ecological conditions than fMRI and is therefore particularly suitable for exploring rehabilitation techniques.

This research aims to study and compare in healthy subjects, using a fNIRS apparatus, the brain regions involved in the performance of a classic mirror therapy task and a virtual mirror therapy task with the IVS3 (Intensive Visual Simulation) apparatus (Dessintey Technology).

The investigations will be carried out by the principal investigator or by specialized technicians from the neurology functional exploration department.

Each acquisition has a duration of 620 seconds, it begins with a rest period of 120 seconds, which corresponds to the baseline.

For each condition the movements are performed at a frequency of 0.5 Hz which seems to be the optimal frequency for observing cortical activation using a metronome. Each movement is therefore performed 10 times per block.

研究设计

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

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age:18 to 40
  • Right handed
  • No neurological disease

排除标准

  • Known allergy to components of the fNIRS device: neoprene

结局指标

主要结局

Compare the level of precuneus activation during conventional mirror therapy (TMC) and virtual mirror therapy (TMV)

时间窗: Day 0

Changes in the concentration of oxyhemoglobin and deoxyhemoglobin measured with fnirs device

次要结局

  • Evaluate the reproducibility of measurements(Day 7)
  • Compare the cortical regions involved during the different mirror therapy tasks and the feelings of the subjects.(Day 0)
  • Compare the level of activation of the contralateral motor regions to visual feedback during TMV and TC.(Day 0)
  • Compare the level of activation of the precuneus during TMC and TC.(Day 0)
  • Compare the level of activation of contralateral motor regions to visual feedback during TMC and TMV.(Day 0)
  • Compare the level of activation of the contralateral motor regions to visual feedback during TMC and TC.(Day 0)
  • Compare the level of precuneus activation during TMV and TC.(Day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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