Visual Plasticity Following Brain Lesions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Change in Motion Discrimination Performance
研究概览
简要总结
The VIBRANT (Vision Improvement through Behavioral Rehabilitation And Neuroplasticity Training) study is a prospective, double-blind, crossover design (within-subject) in participants with homonymous hemianopia-a type of visual field loss resulting from damage to the post-chiasmatic visual pathways. It aims to investigate whether transcranial random noise stimulation (tRNS) combined with perceptual learning-based training has potential for improving visual impairments.
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, Investigator)
盲法说明
This study is double-blind, meaning that both the participants and the researchers will be blinded to the treatment conditions.
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
- •A. Stroke, brain tumor, or traumatic brain injury patients
- •Inclusion Criteria:
- •At least 18 years of age.
- •Capable of providing informed consent and complying with study procedures.
- •Unilateral or bilateral focal brain damage causing loss of vision.
- •At least three months post-stroke or traumatic brain injury, or a stable brain tumor within the past year.
排除标准
- •Severe CNS diseases or disorders unrelated to the focal lesion, which could interfere with study results.
- •Severe mental health challenges that could interfere with study results, or current or recent (within the past 6 months) drug or alcohol abuse or addiction as defined by DSM-
- •Vision loss resulting from ocular disease or disorder.
- •B. Healthy volunteers (age-matched controls):
- •Inclusion Criteria:
- •At least 18 years of age.
- •Capable of providing informed consent and complying with study procedures.
- •Exclusion Criteria:
- •Any CNS diseases or psychiatric disorders (e.g., epilepsy, schizophrenia) that would interfere with study results.
- •Previous head injury.
- •Present or past (within past 6 months) drug or alcohol abuse or addiction based on DSM-5.
研究组 & 干预措施
tRNS with perceptual learning-based training
Each 2-day session consists of up to three 18-minute transcranial random noise stimulation (tRNS) paired with perceptual learning-based training.
干预措施: transcranial random noise stimulation (tRNS) (Device)
tRNS with perceptual learning-based training
Each 2-day session consists of up to three 18-minute transcranial random noise stimulation (tRNS) paired with perceptual learning-based training.
干预措施: Perceptual learning-based training (Behavioral)
Sham with perceptual learning-based training
Each 2-day session consists of up to three 18-minute sham stimulation paired with perceptual learning-based training.
干预措施: Sham Stimulation (Device)
Sham with perceptual learning-based training
Each 2-day session consists of up to three 18-minute sham stimulation paired with perceptual learning-based training.
干预措施: Perceptual learning-based training (Behavioral)
结局指标
主要结局
Change in Motion Discrimination Performance
时间窗: Study visit 1 to 2 (within a week), and study visit 3 to 4 (within a week)
Change in accuracy on a computerized motion direction discrimination task programmed in the lab. The task assesses participants' ability to discriminate the direction of the peripherally presented moving dots at two locations (one within the blind field and the other at a mirror-symmetric location in the intact visual field). Accuracy is defined as the proportion of correct responses out of the total number of trials completed.
次要结局
- Visual Field Change(Baseline (pre-intervention) to post-intervention follow-up (approximately 3 months, up to 6 months))
- Visual Perception Change(Baseline (pre-intervention) to post-intervention follow-up (approximately 3 months, up to 6 months))
- Quality of Life Change(Baseline (pre-intervention) to post-intervention follow-up (approximately 3 months, up to 6 months))
研究者
Tong (Tina) Liu
Assistant Professor of Neurology
Georgetown University