跳至主要内容
临床试验/NCT03807401
NCT03807401招募中不适用

To Simulate Prismatic Adaptation in Healthy Subject : a Technical Innovation in Favour of Autonomy and Independence in Daily Life Following a Brain Injury

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 480 人开始时间: 2019年10月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
480
试验地点
1
主要终点
sensorimotor performances : measure of deviations in mm

研究概览

简要总结

Unilateral neglect is a neuropsychological disorder reflected by a disturbance in the spatial exploration and distribution of directed attention affecting the contralateral part of space and body relatively to the brain lesion. The chronic aspect of this pathology leads to a poor progression following rehabilitation and a decreased independence of patients in daily life. Thus, it is necessary to set up efficient and long lasting therapies for unilateral neglect patients to improve their daily quality of life. Prismatic adaptation is now a classical method which allows patients to improve their neglect through corrective pointing movements in response to a lateral displacement of the visual field. A large and growing body of literature has investigated prismatic adaptation as a very promising rehabilitation method, improving both visuomotor and cognitive features of unilateral neglect. However, its effects are somehow irregular and clinical applications of this method are still limited. The necessity for patients to come to the hospital to take advantage of prismatic adaption sessions draws some limitations about our knowledge concerning 1) the temporal dynamic of prism adaptation effects on a long-term basis and 2) the optimal duration of treatment (most of the time constrained by the hospitalization duration) and its therapeutical effects on a very long-term basis. Moreover, a large number of patients also suffer from motor deficits which reduce the possibility to optimize the prismatic adaptation session.

Thus, the aim of this project is to develop and validate others modalities of prismatic adaptation which can be applied at home and for a longer duration. These modalities should allow the investigator to get insights about the temporal dynamic of prismatic adaptation on the cognitive system. First, the investigator will investigate the effects of a prismatic adaptation modality using virtual reality to reproduce the lateral displacement induced by the prismatic goggles. He will also investigate prismatic adaptation induced by motor imagery, i.e. with mental representations of pointing movements without concomitant motor execution. This project could enhance the fundamental knowledge and enable to design new modalities of therapeutical use of prismatic adaptation (virtual or imaged) so as to allow a home-based treatment and follow-up. Thus, the aim of this project is to demonstrate the implication of similar mechanisms through different modalities (virtual and imaged compared to classical application) and the feasibility of these new modalities of healthy subjects. Thereafter, the aim will be to use knowledge acquired during this project to set up clinical trials to test for the efficiency of these modalities on a long-term basis in a pathological population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female
  • Right-handed
  • Aged 18 to 70
  • Normal or corrected vision
  • Signed written informed consent
  • Affiliated to a health care organism.

排除标准

  • Neurological or psychiatric disorder
  • Cognitive disorders
  • presence of corrective eyeglasses
  • Right upper limb orthopedic disorders

研究组 & 干预措施

Classical prismatic adaptation

Active Comparator

Classical prismatic adaptation arm will be divided into two subgroups corresponding to the side of the prismatic displacement (right or left)

干预措施: Prismatic goggles (Behavioral)

Virtual prismatic adaptation

Experimental

virtual prismatic adaptation arm will be divided into two subgroups corresponding to the side of the prismatic displacement (right or left)

干预措施: Virtual reality device (Behavioral)

Imaged prismatic adaptation

Experimental

Imaged prismatic adaptation arm will be divided into two subgroups corresponding to the side of the prismatic displacement (right or left)

干预措施: Prismatic goggles (Behavioral)

结局指标

主要结局

sensorimotor performances : measure of deviations in mm

时间窗: Day 0 - right after adaption

Task 1 : Line bisection to assess visuo-spatial bias In the test, the investigator will measure the deviation (in mm) between the response of the subject and the reference point. For the Line bisection test, the reference point is the middle of the line.

Visuospatial performances : measure of deviations in mm

时间窗: Day 0 - right after adaption

Task 1 : Line bisection to assess visuo-spatial bias In the test, the investigator will measure the deviation (in mm) between the response of the subject and the reference point. For the Line bisection test, the reference point is the middle of the line.

sensorimotor performances : measure of deviations in mm

时间窗: Day 0 - right before adaption

Task 1 : Line bisection to assess visuo-spatial bias In the test, the investigator will measure the deviation (in mm) between the response of the subject and the reference point. For the Line bisection test, the reference point is the middle of the line.

Visuospatial performances : measure of deviations in mm

时间窗: Day 0 - right before adaption

Task 1 : Line bisection to assess visuo-spatial bias In the test, the investigator will measure the deviation (in mm) between the response of the subject and the reference point. For the Line bisection test, the reference point is the middle of the line.

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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