NCT04008589已完成1 期
Non-invasive Current Stimulation for Restoration of Vision (REVIS) After Unilateral Occipital Stroke
University of Magdeburg2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2014年1月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Size of the visual field
研究概览
简要总结
The aim of the study is to evaluate effects of current stimulation of the brain on vision parameters, vision-related quality of life, and physiological parameters to uncover mechanisms of vision restoration. These include EEG-spectra and coherence measures, and visual evoked potentials. The design of stimulation protocols involves an appropriate sham-stimulation condition and sufficient follow-up periods to test whether the effects are stable. This is the first application of non-invasive current stimulation for vision rehabilitation in stroke-related visual field deficits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HH due to ischemic or hemorrhagic stroke
- •age between 18 and 75 years
- •lesion age at least 6 months
- •stable visual field defect across baseline measurement (subjects with spontaneous fluctuations and recovery of vision excluded)
- •presence of residual vision and detectable gradual transition between the intact and the absolutely blind part of the visual field according to evaluation of the clinician
- •best corrected visual acuity at least 0.4 (20/50 Snellen) or better
排除标准
- •known active malignancy
- •eye or central nervous system diseases that interfere with the study (including poorly controlled glaucoma)
- •electric or electronic implants (e.g. heart pacemaker)
- •metal artifacts in the eyes or head (with the exception of dental prosthesis or shunts)
- •expected low compliance (e.g. in case of known psychiatric disease, known drug abuse, and dementing syndromes)
- •epileptic seizure within the last 10 years
- •use of antiepileptic or sedative drugs
结局指标
主要结局
Size of the visual field
时间窗: 2 weeks
Mean threshold in standard static perimetry and and detection accuracy in HRP
次要结局
- Resting EEG power spectra(2 weeks)
研究者
Bernhard A. Sabel
Prof.
University of Magdeburg
研究点 (2)
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