Feasibility Clinical Study of a Novel Hybrid Brain Computer Interface for Control of Sensory-motor Coupling in Post-stroke Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Electrotactile BCI system accuracy
研究概览
简要总结
HYBIS project aims to develop an innovative and unique hybrid Brain-Computer Interface (BCI) system. This BCI system is envisioned as a novel tool for targeted reinforcement of sensory motor coupling, specifically dedicated for upper-limb post-stroke rehabilitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age over 18 years old at the time of enrolment
- •history of cerebrovascular insult verified by computerized tomography or magnetic resonance imaging;
- •stoke occurred not more than 6 months prior to study enrolment;
- •subject need to be medically and neurologically stable determined by medical history and documented neurological examination;
- •ability to understand, communicate and cooperate with the research team;
- •ability to sit for at least 45 minutes and the ability to adhere to the study rehabilitation protocol.
排除标准
- •any neurologic condition (beyond the stroke) or physical condition that impaired function of the affected arm
- •a substantial cardiopulmonary or metabolic disorder or other major medical complication;
- •history of seizures;
- •moderate to severe hemispatial neglect or anosognosia involving the affected arm;
- •severe sensory deficit;
- •inability to understand, cooperate, and adhere to the study procedures;
- •severe spasticity defined as Ashworth scale score of 4 in the affected arm;
- •contraindication to stimulation system placement;
- •nursing a child;
- •pregnancy.
研究组 & 干预措施
Stroke patients
Experimental group of stroke survivors for testing the feasibility of a BCI system
干预措施: BCI feasibility test (Device)
结局指标
主要结局
Electrotactile BCI system accuracy
时间窗: within 30 minutes after experimental session
Electrotactile BCI system accuracy is a measure of feasibility of the prototype device. Accuracy \[0 -100 %\] of classification of user's mental strategy (tactile attention task towards one of the two electrical stimulation hotspots), where higher values of accuracy are related to better system control.
Motor Imagery BCI system accuracy
时间窗: within 30 minutes after experimental session
Motor Imagery BCI system accuracy is a measure of feasibility of the prototype device. Accuracy \[0 - 100 %\] of classification between rest and imaginary movement in a cue-based manner, , where higher values of accuracy are related to better system control.
次要结局
- Fugl Meyer sensory score for upper extremity(immediately after experimental session)
- NASA-TLX(within 30 minutes after experimental session)
研究者
Konstantinovic Ljubica
Professor
University of Belgrade