Multicenter Study of Paraorbital-Occipital Alternating Current Stimulation Therapy 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
- 90
- 试验地点
- 8
- 主要终点
- Detection accuracy (DA) change in percent over baseline within defective visual field
研究概览
简要总结
Aim is to validate that non-invasive brain stimulation can increase cortical excitability in the visual system. The investigators assess if transcranial alternating current stimulation (tACS) can improve visual field size in patients with optic nerve damage. Hypothesis: tACS would improve visual functions within the defective visual field (primary outcome measure).
详细描述
In addition, the correlation between the brain-derived neurotrophic factor (BDNF) or other plasticity markers are correlated to the improvement of the visual field after stimulation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with optic nerve lesion
- •stable visual field defect with residual vision
- •lesion age at least 6 months
- •age at least 18 years
- •no completely blindness, residual vision still existent
排除标准
- •electric or electronic implants, e.g. heart pacemaker
- •any metal artefacts in head and truncus
- •auto-immune diseases in acute stage
- •mental diseases, e.g. schizophrenia etc.
- •unstable diabetes, diabetes causing diabetic retinopathy
- •addiction
- •high blood pressure (max. 160/100 mmHg)
- •instable or high level of intraocular pressure (i.e. > 27 mmHg)
- •retinitis pigmentosa
- •pathological nystagmus
- •presence of an un-operated tumor anywhere in the body
- •pregnant or breast-feeding women
- •photo sensibility
- •Fundus hypertonicus
- •acute conjunctivitis
结局指标
主要结局
Detection accuracy (DA) change in percent over baseline within defective visual field
时间窗: Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course
Central visual fields assessed with computer-based high-resolution perimetry (HRP). Based on such plots, areas of the visual field are characterized as intact, partially damaged or absolutely impaired (blind). Detection accuracy (DA) change in percent above baseline within defective visual field sectors is defined as the primary outcome criterion.
次要结局
- DA change in percent over baseline regarding the damage region of the tested visual field (computer-based high-resolution perimetry)(Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course)
- EEG parameters(Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course)
- Reaction time change in ms(Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course)
- Visual acuity (VA)(Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course)
- DA in static and kinetic conventional perimetry(Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course)
研究者
Bernhard A. Sabel
Principle PI
University of Magdeburg