Multi-day Effect of Noninvasive Brain Stimulation in Adults With Amblyopia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Crowded Visual Acuity
研究概览
简要总结
The goal of this randomized controlled trial is to investigate the effectiveness of non-invasive brain stimulation in treating adults with amblyopia. The main questions it aims to answer are:
- What are the effects of non-invasive brain stimulation on neuronal plasticity in the visual cortex of adults with amblyopia, and does it produce lasting changes?
- Do cumulative sessions of non-invasive brain stimulation influence neural plasticity and higher-order visual functions in adults with amblyopia?
The investigators hypothesize that non-invasive brain stimulation will show a positive cumulative effect after five (5) consecutive days of stimulation on visual perception and function in adults with amblyopia.
Participants will be randomized into one of two treatment groups:
- High-frequency transcranial random noise stimulation (hf-tRNS).
- Sham stimulation.
Researchers will compare baseline measurements of crowded visual acuity, contrast sensitivity, stereoacuity, phosphene thresholds, global motion perception, form pattern recognition and pattern-reversal visual evoked potentials (VEPs) to post-treatment measurements for each group.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults between 18 and 55 years of age
- •Formal diagnosis of amblyopia in one or both eyes of any etiology
排除标准
- •History of optic nerve disease, including glaucoma and optic neuritis
- •History of neurological conditions, including demyelinating disease or stroke
- •Presence of metal or electronic implants in or on the body, including pacemakers
- •Taking medications that can affect normal neurological function, including antipsychotics, antiepileptics, and opioids
结局指标
主要结局
Crowded Visual Acuity
时间窗: Pre- and post-treatment (Days 1-5); 24-hour follow-up (Day 6); 72-hour follow-up (Day 8); and 10-day follow-up (Day 15).
A change in crowded visual acuity is measured in LogMAR from baseline.
Stereo Acuity
时间窗: Pre- and post-treatment (Days 1-5); 24-hour follow-up (Day 6); 72-hour follow-up (Day 8); and 10-day follow-up (Day 15).
A change in stereo acuity is measured in arc seconds from baseline.
Phosphene Threshold
时间窗: Pre- and post-treatment (Days 1-5); 24-hour follow-up (Day 6); 72-hour follow-up (Day 8); and 10-day follow-up (Day 15).
A change in phosphene threshold (%) from baseline.
Global Motion Perception
时间窗: Pre- and post-treatment (Days 1-5); 24-hour follow-up (Day 6); 72-hour follow-up (Day 8); and 10-day follow-up (Day 15).
A change in global motion perception coherence threshold (%) from baseline.
Form Pattern Recognition
时间窗: Pre- and post-treatment (Days 1-5); 24-hour follow-up (Day 6); 72-hour follow-up (Day 8); and 10-day follow-up (Day 15).
A change in form pattern recognition coherence threshold (%) from baseline.
Pattern-reversal Visual Evoked Potentials (pVEP)
时间窗: Pre-treatment (Day 1); post-treatment (Day 5); 24-hour follow-up (Day 6); 72-hour follow-up (Day 8); and 10-day follow-up (Day 15).
A change in N75-P100 amplitudes and P100 latencies from baseline.
次要结局
未报告次要终点
研究者
Arijit Chakraborty
Assistant Director of Research
Midwestern University