Treatment of Patients With Optic Neuropathy Using Transorbital Alternating Current Stimulation - a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 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 within the defective visual field sectors of the visual field (primary outcome measure).
详细描述
In a prospective, double-blind, randomized, placebo-controlled clinical trial 22 patients with optic nerve damage were randomly assigned to a rtACS- (n=12) or placebo-group (n=10). Visual field measures, visual acuity and EEG-recordings were collected before and after a daily 20-40min treatment for 10-days and at a 2-months-follow-up. Primary outcome measure was detection accuracy (DA) in defective visual field sectors of computer-based high resolution perimetry (HRP). Secondary outcome parameters included DA in static and kinetic perimetry, reaction time (RT) in HRP, visual acuity (VA), contrast vision, and EEG power spectra.
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 70 Years（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
排除标准
- •heart pacemakers and any metal artefacts in head and truncus
- •epileptic seizure within the last 3 years
- •photosensitive epilepsy as determined by EEG
- •mental diseases (schizophrenia etc.)
- •unstable diabetes, diabetes causing diabetic retinopathy
- •macular degeneration, maculopathy with decimal visual acuity below 0.4
- •high blood pressure
- •instable or high level of intraocular pressure (i.e. >27 mmHg)
- •presence of an un-operated tumor anywhere in the body
- •total blindness
- •primary or secondary glaucoma
- •pathological nystagmus
研究组 & 干预措施
rtACS (Verum condition)
Repetitive transorbital alternating current stimulation (rtACS)
干预措施: Repetitive transorbital alternating current stimulation (Device)
Sham stimulation (placebo condition)
A clicking sound was presented and the same electrode montage set-up was used during rtACS- and placebo-stimulation, except that placebo patients received no current (stimulator turned off)
结局指标
主要结局
Detection Accuracy (DA) Change in Percent Over Baseline Within Defective Visual Field Sectors
时间窗: Outcome measures were assessed at initial diagnostics (baseline) and after 10 days stimulation at post diagnostics
Central visual 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). Detection accuracy (DA) change in percent above baseline within defective visual field sectors was defined as the primary outcome criterion.
次要结局
- Other Visual and EEG Parameters(Nov 2006 - Dec 2010)
研究者
Bernhard A. Sabel
Study leader
University of Magdeburg