Treatment of Patients With Optic Nerve Damage Patients Using Electrostimulation: a Home Stimulation Study
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Visual field size
研究概览
简要总结
The aim of the present study is to investigate the possibilities of visual field enhancement with electrical stimulation (ES) as a home stimulation method, in a total of 50 patients with optical neuropathy, who have already been treated with ES in the past.
Furthermore, factors responsible for response variability and treatment effectiveness are also explored: (i) the role of mental stress (or stress resilience), (ii) the status of biomarkers, such as the systemic stress hormone levels and blood supply to the eye and brain (specifically vascular dysregulation) and (iii) the influence of personality, anxiety, depression and lifestyle. The study serves to further validate this ES procedure for the treatment of visual impairment. Specifically, better efficacy, better compliance, lowest response variability are expected after long-term home use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 glaucoma, disease duration 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
- •autoimmune diseases in the acute stage
- •neurological and mental diseases
- •diabetic retinopathy
- •addictions
- •hypertension (maximum 160/100 mmHg)
- •retinitis pigmentosa-
- •pathological nystagmus
- •non-distant tumors or recurrent tumors
- •photosensitivity
- •pregnancy
- •electric or electronic implants (e.g. heart pacemaker)
- •metal implants in the eyes or head (with the exception of dental prosthesis or shunts)
结局指标
主要结局
Visual field size
时间窗: 3 months
Static perimetry and high resolution perimetry will be used to measure the visual field sizes
次要结局
- EEG connectivities in the visual system(3 months)
- Level of vascular regulation/dysregulation in the eye(3 months)
研究者
Bernhard A. Sabel
Head of Institute, Professor
University of Magdeburg