Validation of a Brain-Computer Interface for Neurorehabilitation With a Randomized Controlled Trial (Validación de Una Interfaz Cerebro-Computadora Para Rehabilitación Neurológica Por Medio de un Ensayo Clínico Controlado y Aleatorizado)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Mean change from baseline in upper limb motor function on the Fugl-Meyer Assessment for the Upper Extremity
研究概览
简要总结
The study's main goal is to determine if clinical and physiological effects of a brain-computer interface intervention for the neurorehabilitation of stroke patients' upper limb are greater than the effects of a sham robotic feedback. For this purpose a randomized controlled trial will be performed to compare somatosensory sham robotic feedback with the same somatosensory feedback controlled with the brain-computer interface output.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Clinical diagnosis of first ischemic stroke
- •Time since stroke onset higher than 3 months and lower than 24 months
- •Hand paresis
- •Normal or corrected to normal vision
- •Without previous diagnosed neurological diseases
排除标准
- •Clinical diagnosis of severe aphasia
- •Clinical diagnosis of severe depression
- •Clinical diagnosis of severe attention deficits
- •Previous diagnosis of traumatic brain injury
- •Previous diagnosis of spinal cord injury
- •Previous diagnosis of peripheral nerve injury
研究组 & 干预措施
Brain-Computer Interface controlled robotic feedback
干预措施: Brain-Computer Interface (Device)
Sham Brain-Computer Interface controlled robotic feedback
干预措施: Sham Brain-Computer Interface (Device)
结局指标
主要结局
Mean change from baseline in upper limb motor function on the Fugl-Meyer Assessment for the Upper Extremity
时间窗: At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset
Analysis of changes on the Fugl-Meyer Assessment for the Upper Extremity will reveal if there is a clinical significant sensorimotor function compared to baseline
Mean change from baseline in upper limb motor function on the Action Research Arm Test
时间窗: At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset
Analysis of changes on the Action Research Arm Test will reveal if there is a clinical significant motor function compared to baseline
次要结局
- Mean change from baseline in corticospinal excitability measured with Transcranial Magnetic Stimulation(At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset)
- Mean change from baseline in cortical activity measured with Functional Magnetic Resonance Imaging(At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset)
- Mean change from baseline in grip strength measured with a dynamometer(At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset)
研究者
Jessica Cantillo-Negrete
Researcher in Medical Sciences
Instituto Nacional de Rehabilitacion