Portable Method of Motor Rehabilitation Using Functional Near-InfraRed Spectroscopy- Based Brain-computer-interface to Augment Post-stroke Recovery (fNIRS-PROMOTE- Recovery)
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Determine when in the course of the study (if at all) fNIRS data contains predictive information regarding the likelihood that participants would respond to at-home BCI rehabilitation.
研究概览
简要总结
Chronic stroke survivors suffering from weaknesses or movement difficulties in their hand/arm are provided a system to aid in at-home rehabilitation for 6 weeks. This rehabilitation system includes a headband that measures and provides feedback from the brain during rehabilitation, together with tablet-based software. Throughout the 6 week rehabilitation period (as well as in a follow-up session 1 month afterwards) several assessments are taken to understand the effect of this rehabilitation on participant's movement abilities, as well as their brain activity.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 90 years
- •6 months - 5 years since most recent stroke
- •Upper-extremity Fugl-Meyer motor function (FMA-UE) score ≤56
- •Able to follow simple commands
- •Fluency in English
- •Not currently receiving therapy for the upper extremity
排除标准
- •Visual impairment that would interfere with visualization of the therapy interface (score >0 on the visual subscale of the NIH stroke scale)
- •Montreal Cognitive Assessment (MoCA) Score ≥10
- •History of significant physical disability prior to most recent stroke
- •Open wounds on the scalp
- •Unable or unwilling to remove hair braids or head coverings which interfere with the Axem Home device efficacy.
- •Inability to follow training instructions for at-home BCI system.
结局指标
主要结局
Determine when in the course of the study (if at all) fNIRS data contains predictive information regarding the likelihood that participants would respond to at-home BCI rehabilitation.
时间窗: 6 weeks
Significant differences between responders and non-responders (as defined in the endpoint of primary objective 1) in fNIRS measures taken either during pre-test fNIRS tasks or at-home BCI sessions which are not accounted for by pre-test FMA-UE assessment scores (see Statistical Methods below for more information).
Determine whether there are participants who respond to at-home upper-extremity BCI rehabilitation.
时间窗: 6 weeks
Some participants will demonstrate a pre- to post-test increase of 6 in the Fugl-Meyer Upper-Extremity subscale.
次要结局
- Determine whether participants can learn to modulate motor cortex brain activity during at-home BCI rehabilitation using a prototype wireless fNIRS device.(6 weeks)
- If secondary objective 1 is met, determine whether learning to modulate motor cortex brain activity during at-home BCI rehabilitation increases the likelihood of benefitting from at-home BCI rehabilitation.(6 weeks)
- If any of primary objectives 1-4 are met, show that the improvements in function achieved by responders to at-home BCI rehabilitation is maintained after the at-home BCI rehabilitation is discontinued.(10 weeks)