DRKS00005949已完成未知
Electrical stimulation for Restoration of Vision after stroke (REVIS) in the damaged visual field after stroke - REVIS
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 75 Years(—)
- 性别
- All
入选标准
- •Prerequisite for participation in the study is a postchiasmatische lesion of the visual pathway with resultant unilateral visual field defect ( Quadrantenanopsie , hemianopia ) after ischemic or hemorrhagic stroke in persons aged 18 to 75 years.
- •For all participants in the study, the postchiasmatische lesion must be at least 6 months old. The visual field defect must be in the comparison of screening and baseline survey to be stable for so that any possible visual field improvements can be clearly attributed to the stimulation and not to a spontaneous recovery of visual acuity or spontaneous fluctuations in performance.
- •The study participants have residual visual performance and typically a gradual transition between the blind area ( visual field loss ) and the intact area of the visual field. The corrected visual acuity in each eye of the participant at least 0.4 ( logMAR ) or 20 /50 ( Snellen ).
排除标准
- •Only subjects included in the study which do not fulfill any of the following exclusion criteria : active malignant tumors , diseases of the eyes or of the central nervous system that interfere with the study ( also includes uncontrolled glaucoma ) , electrical or electronic implants (eg pacemakers) ; metallic artifacts in the eye or the head ( with the exception of dental prostheses and shunts) ; expected low compliance ( for example, as a result of psychiatric or alcohol disorder or dementia syndrome); epilepsy disease within the last 10 years , intake of antiepileptic drugs or sedatives ; are pregnant or breastfeeding women.
研究者
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