Paraorbital-Occipital Alternating Current Stimulation Therapy of Patients With Post-Chiasmatic Lesions
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- detection accuracy (%) in visual field measures over baseline
研究概览
简要总结
Visual field areas, which are not absolutely blind, are hypothesized to have some residual capacities that constitute their potential for vision restoration. Vision restoration can be achieved by varies methods including behavioral training and electrical brain stimulation such as transcranial direct current stimulation (tDCS) and repetitive transorbital alternating current stimulation (rtACS) which are able to influence the excitability and activity of cortical areas.
It is hypothesized that transorbital alternating current stimulation (tACS) can improve the residual field of vision in patients with post-chiasmatic lesions.
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
- •lesion of the tractus opticus or of the visual cortex
- •lesion age > 6 months
- •stable visual field defect with residual vision
排除标准
- •electric or electronic implants, e.g. heart pacer
- •any metal artefacts in the head
- •Auto-immune diseases in acute stage
- •mental diseases, e.g. schizophrenia etc.
- •diabetic retinopathy
- •addictive diseases
- •blood pressure above 160/100 mmHg
- •instable or high level of intraocular pressure above 27 mmHg
- •retinitis pigmentosa
- •pathological nystagmus
- •presence of an un-operated tumor or tumor relapse (patients with non-progressive tumor are eligible if study participation is recommended by medical authorities)
- •focal findings in EEG or photosensitivity (patients with single seizure more than 10 yrs ago may participate)
- •recurrent transitional ischemic attacks after stroke
- •arteriosclerosis of large blood vessels with stenosis >75%
- •severe coronary heart disease (CHD)
- •unstable angina pectoris
- •diabetes with blood glucose level > 9 mmol/l
- •myocard infarct/ cardiomyopathy
- •ventricular fibrillation
- •risk of vascular thrombosis
- •pregnant or breast-feeding women
研究组 & 干预措施
Verum stimulation
repetitive transorbital alternating current stimulation (rtACS)
干预措施: Verum stimulation (Device)
Placebo stimulation
compared to verum stimulation the same electrode montage set-up is used during placebo stimulation, except that placebo patients receive a minimal stimulation
干预措施: Placebo stimulation (Device)
结局指标
主要结局
detection accuracy (%) in visual field measures over baseline
时间窗: baseline to 8 weeks after stimulation
visual stimuli detection accuracy in residual and absolutely defect visual field will be assessed using computer-based high resolution perimetry (HRP)
次要结局
- detection accuracy (%) in the intact visual field over baseline(baseline to 8 weeks after stimulation)
- reaction time (ms)(baseline to 8 weeks after stimulation)
- EEG parameters(baseline to 8 weeks after stimulation)
- conventional perimetry(baseline to 8 weeks after stimulation)
- visual acuity (LogRAD)(baseline to 8 weeks after stimulation)
研究者
Bernhard A. Sabel
Prof. Dr.
University of Magdeburg