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临床试验/NCT01730560
NCT01730560已完成不适用

Rehabilitation For Acquired Visual Field Defects: Development Of A Bottom-Up Approach

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2010年11月29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
22
试验地点
2
主要终点
Difference in performance (mean reaction time - RT) of an ecological visual search task between pre-tests and immediate post-test for each patient according to treatment (A or B).

研究概览

简要总结

Cortical Visual Field Defects (CFVD) are common after acquired brain injury. They often cause problems with reading and visual exploration which impact on patients' quality of life. Apart from the substitutive method that uses prisms directly placed on glasses, two main rehabilitative methods have been explored previously: one restorative and one compensatory. The most effective methods seem to be based on compensatory training paradigms that target eye movements. They rely on voluntary mass-practice that induces changes in exploratory saccadic behaviour, particularly into the blind hemifield. Previous studies using this method have shown changes in visual scanning patterns but with only a marginal profit in terms of functional benefit.

In the present study, the investigators developed a new approach to the compensatory visual field training based solely on a bottom-up mechanism. It does not require the patients' ability to voluntarily maintain attention oriented to the affected field, which may be difficult for brain-damaged patients. As previously reported in other pathological contexts (e.g. use of prism adaptation or sensory stimulation in neglect patients), bypassing voluntary and conscious implication of the patient can produce improvements by a more automatic process.

The investigators hypotheses are: 1) that a novel ramp-step search paradigm can be used by hemianopic patients to automatically improve targeted eye movements into their blind visual field; and 2) that this will lead to behavioural improvements on ecologically valid tests of visual search.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male/Female
  • Stroke (ischemia or hemorrhage) documented by CTscan or MRI
  • Traumatic brain injury (TBI) documented by CTscan or MRI
  • Right or Left hemianopia defined by perimetry
  • All subjects must be between the ages of 18-80
  • Aetiology of visual field defect : Stroke (ischemia or hemorrhage)
  • Delay post-stroke : at least 6 months
  • Only one lesion on CTscan or MRI (performed in a maximal delay of 6 months)
  • Corrected monocular visual acuity > 5/10
  • Possible understanding of experimental conditions
  • Patient being able to be quiet and sit during at least 2 hours
  • Having given written informed consent prior to any procedure related to the study
  • Availability for the period of the study
  • Covered by a Health System where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research

排除标准

  • Ophthalmologic criteria : monocular visual acuity < 4/10, strabismus , diplopia , ocular instability , nystagmus, maculopathy , glaucoma , retinopathy , orthoptic rehabilitation
  • Neurologic criteria : sever phasic disturbances , neurologic degenerative affection , non controlled seizure , severe handicap non compatible with prolonged sit position or concentration during 30 consecutive minutes
  • No command of french language
  • Non stabilized medical situation
  • Females who are pregnant, nursing, or planning a pregnancy during the study period, or females of childbearing potential, not using a reliable means of contraception.
  • Not under any administrative or legal supervision

研究组 & 干预措施

Arm 1:Treatment A

Experimental

Treatment A (active) followed by treatment B (neutral)

干预措施: Treatment A (Other)

Arm 2: Treatment B

Experimental

Treatment B (neutral) followed by treatment A (active)

干预措施: Treatment B (Other)

结局指标

主要结局

Difference in performance (mean reaction time - RT) of an ecological visual search task between pre-tests and immediate post-test for each patient according to treatment (A or B).

时间窗: 1 week

次要结局

  • Errors and omissions at each evaluation session for the visual search task(1, 2 and 5 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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