Brain-Computer Interface (BCI) With Virtual Reality (VR) in Upper Limb Rehabilitation After Stroke: A Randomized Crossover Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in Upper Limb Motor Function (Fugl-Meyer Assessment - Upper Extremity)
研究概览
简要总结
The goal of this clinical trial is to investigate if training sessions of motor imagery associated with brain-computer interface and motor observation through virtual reality (MI-VR-BCI) can help to improve arm and hand recovery after a stroke. The main questions to answer are:
- Can adding MI-BCI-VR sessions improve upper limb movement?
- Can it help stroke survivors perform daily activities more easily?
- Does this type of training improve brain activity and connections related to movement?
Researchers will compare this type of intervention with motor imagery associated with a standard brain-computer interface intervention (MI-BCI) to see if there are added effects to upper limb function, activity and brain connections.
Participants will :
- Perform two intervention periods in a random order: one with MI-VR-BCI training sessions and other with MI-BCI training sessions. Each period will involve 3 weekly sessions of training, during 6 weeks, with the intervention periods being separated by 3 weeks.
- Complete four assessment sessions: one at the beginning and another at the end of each intervention period.
详细描述
Stroke is a leading cause of long-term disability worldwide, often resulting in upper limb (UL) impairment. Approximately 70% of stroke survivors experience UL dysfunction, with a significant portion continuing to show deficits into the chronic phase. This impacts independence and quality of life, highlighting the need for effective rehabilitation strategies.
Brain-Computer Interface (BCI) interventions have shown promise in improving UL function by enabling patients to modulate brain activity through neurofeedback in a closed-loop system. When combined with multisensory feedback (visual, auditory, and somatosensory) BCIs may promote neuroplasticity and motor recovery. The use of Motor Imagery (MI) and embodied Virtual Reality (VR) may further enhance motor learning by reinforcing motor patterns and creating meaningful, immersive rehabilitation experiences.
Despite encouraging evidence, the clinical and neurophysiological benefits of combining BCI with VR and MI remain underexplored, particularly when associated with longer intervention periods, the impact in activities of daily living and the influence of patient-specific traits such as motor, cognitive, or behavioral dimensions. In light of these considerations, the primary objectives of this study are:
- To assess the preliminary effects of applying a motor imagery based Brain-Computer Interface with Virtual Reality (MI-BCI-VR) paradigm on upper limb function and activity in individuals with stroke.
- To evaluate the neurophysiological effects of this intervention on brain activity and its relationship with clinical measures of upper limb function.
The secondary objectives of the study are:
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of stroke confirmed by neuroimaging, with resulting upper limb hemiparesis.
- •Time since stroke between 6 and 24 months at the time of selection.
- •Sufficient cognitive ability to understand and follow the intervention procedures.
- •Spasticity score <3 on the Modified Ashworth Scale in upper limb muscle groups.
- •Adults aged 18 to 80 years.
- •Ability to remain seated for approximately 2 hours.
- •Motivation to participate and capacity to provide informed consent.
- •Undergoing conventional rehabilitation therapy during the study period.
排除标准
- •Severe communication difficulties preventing comprehension or execution of instructions.
- •Skin lesions, allergies, or metal implants in the cephalic region, or history of craniectomy, that hinder electrode placement or interfere with EEG signal acquisition.
- •Concomitant neurological or musculoskeletal conditions affecting upper limb motor function.
- •Other neurological, musculoskeletal, or psychiatric conditions that may compromise participation or study outcomes (e.g., major depression, severe visual impairment, photosensitive epilepsy, frequent vertigo or dizziness).
- •Upper limb impairment due to a previous stroke.
研究组 & 干预措施
MI-VR-BCI Training
Participants will perform motor imagery-based brain-computer interface training combined with immersive virtual reality and multimodal feedback (visual, auditory, and haptic).
干预措施: Motor Imagery-based Brain-Computer Interface coupled with Virtual Reality (MI-BCI-VR) (Device)
MI-BCI
Participants will perform motor imagery-based brain-computer interface (MI-BCI) training based on a cue-based protocol.
干预措施: Motor Imagery-based Brain-Computer Interface (MI-BCI) (Device)
结局指标
主要结局
Change in Upper Limb Motor Function (Fugl-Meyer Assessment - Upper Extremity)
时间窗: Baseline and end of each 6-week intervention period (up to 15 weeks total, including washout).
Within-subject difference in the change in upper limb motor function, as assessed by the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE), between the two intervention conditions (MI-BCI-VR vs. MI-BCI). FMA-UE scores range from 0 to 66, with higher scores indicating better motor function and less impairment.
Change in Upper Limb Activity (Action Research Arm Test - ARAT)
时间窗: Baseline and end of each 6-week intervention period (up to 15 weeks total, including washout).
Within-subject difference in the change in upper limb activity, as assessed by the Action Research Arm Test (ARAT), between the two intervention conditions (MI-BCI-VR vs. MI-BCI). The ARAT is a standardized measure that evaluates upper limb functioning through tasks involving grasp, grip, pinch, and gross movement. Scores range from 0 to 57, with higher scores indicating better functional ability. This outcome assesses the impact of the intervention on functional use of the affected arm in daily activities.
Change in EEG Event-Related Desynchronization/Synchronization (ERD/ERS)
时间窗: During each intervention session across both 6-week intervention periods (up to 15 weeks total, including washout).
Changes in event-related desynchronization and synchronization (ERD/ERS) during motor imagery tasks, derived from EEG recordings to assess intervention-related modulation of sensorimotor cortical activity.
Change in EEG Hemispheric Lateralization Index
时间窗: During each intervention session across both 6-week intervention periods (up to 15 weeks total, including washout).
Changes in EEG-derived hemispheric lateralization indices during motor imagery tasks, used to evaluate intervention-related reorganization of cortical motor networks.
Change in EEG Connectivity Measures
时间窗: During each intervention session across both 6-week intervention periods (up to 15 weeks total, including washout).
Exploratory changes in EEG-based functional connectivity metrics between motor-related cortical regions during motor imagery tasks.
次要结局
未报告次要终点
研究者
Athanasios Vourvopoulos
Principal Investigator
Technical University of Lisbon