Electrical Stimulation for Restoration of Vision After Stroke in the Damaged Visual Field of Patients With Unilateral Stroke (REVIS Helsinki)
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Improved detection in the visual field defined as the percentage change of the stimulus detection rate in High-resolution perimetry (HRP)
研究概览
简要总结
Occipital stroke is associated with homonymous visual field defects (occurring on one side of the visual field). Despite spontaneous recovery, some degree of defect is often permanent. Currently, no treatment exists for such visual field defects.The purpose of this study is to test the efficacy of a type of electrical brain stimulation method, transcranial alternating current stimulation, in reducing these type of visual field defects in their chronic stage.
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
- Double (Participant, 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
- •Occipital ischemic or hemorrhagic stroke 6 months or older
- •Hemianopia or quadrantanopia demonstrated by standard automated perimetry
- •Visual field defect is stable across baseline
- •Presence of residual vision and detectable gradual transition between the the intact and absolutely blind parts of the visual field
- •Best corrected visual acuity for at least one eye better or equal to 0.4
排除标准
- •Eye or central nervous system disease that interferes with the study
- •Cardiac pacemaker
- •Other metallic devices or implants precluding participation in MRI scans
- •Pregnancy or lactation period
- •Epileptic seizures in the past 10 years
- •Use of antiepileptic or sedative drugs
- •Expected low compliance due to substance abuse
- •Known active malignancy
结局指标
主要结局
Improved detection in the visual field defined as the percentage change of the stimulus detection rate in High-resolution perimetry (HRP)
时间窗: Change between 3-7 days pre-treatment, at 3-7 days post-treatment, and at 2 months post-treatment
HRP is a computer-based perimetry using a supra-threshold stimulus. It is used to detect residual vision between the absolute defect and seeing field and to monitor subtle changes in perceptual ability. HRP is performed in fixation control using an eye tracker. The primary outcome measure will be the percentage change in HRP detection accuracy between pre-test and post-test measurements.
次要结局
- The change in extent of visual fields in standard automated perimetry(Change between 3-7 days pre-treatment, at 3-7 days post-treatment, and at 2 months post-treatment)
研究者
Turgut Tatlisumak, MD, PhD, FAHA, FESO
Associate Professor
Helsinki University Central Hospital