Paraorbital-occipital Alternating Electric Current Stimulation in Patients With Optic Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Detection accuracy (DA) change in percent over baseline within defective visual field sectors
研究概览
简要总结
Non-invasive brain stimulation can increase cortical excitability in the visual system, but it is not known if this is of clinical value. The investigators now assessed if repetitive, transcranial alternating current stimulation (rtACS) can improve visual field size in patients with optic nerve damage. The investigators hypothesized that rtACS would improve visual functions with the defective visual field sectors of the visual field (primary outcome measure).
详细描述
exploratory, randomized, controlled study
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
- Quadruple (Participant, Care Provider, 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
- •residual vision
- •patients with optic nerv lesion
- •lesion age at least 6 months
- •stable visual field defect
排除标准
- •electric or electronic implants such as pace maker
- •any metal artefacts in head and truncus
- •epilepsia
- •photosensitive epilepsy as determines by EEG
- •autoimmune illnesses in acute stage
- •mental diseases such e.g. schizophrenia etc.
- •diabetes causing diabetic retinopathy
- •addiction
- •high blood pressure
- •unstable or high level intraocular pressure (i.e. > 27 mmHg)
- •retinitis pigmentosa
- •pathological nystagmus
- •presence of an un-operated tumor or tumor recidive
结局指标
主要结局
Detection accuracy (DA) change in percent over baseline within defective visual field sectors
时间窗: between baseline and 60 days after stimulation
Central visus fields were assessed with computer based high-resolution perimetry (HRP). Based on such plots, areas of the visual field were characterized as intact, partially damaged or absolutely impaired (blind).
次要结局
- Visual Parameters 2(baseline to 60 days after stimulation)
- Visual Parameters 1(baseline to 60 days after stimulation)
- Visual Parameters 3(baseline to 60 days after stimulation)
- Visual Parameters 4(baseline to 60 days after stimulation)
- EEG parameters(baseline to 60 days after stimulation)
研究者
Bernhard A. Sabel
Director, Inst Med Psychol
University of Magdeburg