Neurofeedback-based Visual Restoration Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 14
- 试验地点
- 4
- 主要终点
- Visual field
研究概览
简要总结
Visual field defects are a common consequence of acquired brain injuries and affect people of all ages. These vision problems make everyday life more difficult-for example, when reading, driving, or moving around safely. However, there is currently no effective therapy to improve visual field defects.
Previous training methods have focused on maximizing brain activity during a task. However, new findings show that the best performance is achieved when the brain is already in a state of high communication before the task. Our research shows that people can learn to increase communication between brain regions through neurofeedback.
Studies have shown that neurofeedback can help people after a stroke: it improves the coordination of brain areas that are important for movement, thereby helping to increase mobility. Building on these findings, this study investigates whether EEG neurofeedback can support the visual centers in the brain to improve vision in patients with chronic visual field defects. The main objective of the study is to evaluate the effectiveness of neurofeedback in improving visual field defects. More specifically, the investigators are investigating the development of visual ability (expansion of the visual field, contrast sensitivity).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic, stable HVFD (homologous lateral quadranopsia or hemianopsia)
- •12 months or more after stroke
- •Age range 50-70
- •Ability to provide informed consent
排除标准
- •Inability to concentrate for long treatment sessions
- •Eye disease with impact on visual field or acuity
- •Presence of non-MRI safe metal in the body
- •New stroke during study period
- •Hemispatial neglect
结局指标
主要结局
Visual field
时间窗: Change from enrollment to post-test at 3 weeks and follow up at 7 weeks (repeated-measures ANOVA)
This will be evaluated using the Haag-Streit Octopus 900 perimetry device (Haag-Streit AG, Köniz, Switzerland). The device features advanced gaze-tracking capabilities that effectively control compensatory eye movements, ensuring accurate measurement of visual field improvements. The Central 30-2 protocol will be followed. The primary outcome will be the change in the Mean Deviation (MD) score in detection threshold (in dB) from baseline to the end of the intervention period within the target area of affected visual field. The MD score represents the overall deviation of the patient's visual field from age-matched normative data, with more negative values indicating greater visual field loss.
次要结局
- Reading speed(Change from enrollment to treatment end at 3 weeks and follow up at 7 weeks (repeated-measures ANOVA).)
- Questionnaire on daily-life impact of the visual impairment(Change from enrollment to treatment end at 3 weeks)
- Changes in alpha-band functional connecticity(Change from entrollment to the end of treatment at 3 weeks.)
- Reading speed(Change from enrollment to treatment end at 3 weeks and follow up at 7 weeks (repeated-measures ANOVA).)
研究者
Adrian Guggisberg
Full Professor
University Hospital, Geneva