Study of Functional Electrical Stimulation With Assistive Support Driven by a Brain-Computer Interface on the Upper Limb Rehabilitation of Chronic Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
研究概览
简要总结
Multi-center, randomized, sham-controlled, double-blind, longitudinal, experimental clinical study to investigate functional recovery effects on the upper limb in chronic stroke patients and the accompanying neural plasticity mechanisms after the application of a brain-computer interface (BCI)-driven functional electrical stimulation (FES) therapy supported by an assistive device (hand orthosis). All the equipment used during the study will be applied in compliance with the indications and methods of use for which it is authorized. Therefore, the results will not extend the indications for the use of the equipment and will not explicitly target industrial development. The study is non-profit and is aimed at improving clinical practice. The study involves two clinical centers. The promoting center is the Vipiteno Neurorehabilitation Department, Italy. The aggregate experimentation center is the Neurology Department of Hochzirl Hospital, Austria. The University of Essex, United Kingdom is the technology provider and data analysis center.
详细描述
This study will investigate whether the combination of FES and an active orthosis assisting the execution of "reach-to-grasp and release" functional arm movements, triggered by a non-invasive, EEG-based BCI, can promote clinically relevant functional recovery of the upper limb in hemiplegic chronic stroke patients,.
The BCI detects sensorimotor rhythms (SMRs) associated with the motor intent of the corresponding attempted movements.
In the study group, only when BCI detects sensorimotor rhythms (SMRs) associated with motor intent, the assistive devices are triggered.
In the control group the assistive devices are triggered randomly (decoupled from the entrained cortical activity).
Similarly to previous BCI-based interventions, the main rationale of the study is that the BCI may transform the FES and orthosis-based therapies and augment their efficacy by restoring the intention-action-perception loop and the contingency between efferent motor commands and afferent sensory feedback. In order to specifically study the contribution of the BCI isolated from the main confounds, a sham control which preserves FES and orthotic support and only removes (blind to both the participants and the therapists) the timely coupling of stimulation to suitable SMR EEG activity is preferred over other control candidates (conventional therapies, no therapy, other placebo approaches).
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)
盲法说明
Participants in both groups (BCI, Sham) are fitted with the exact same equipment (EEG cap, FES device, assistive hand orthosis). In the BCI group, FES stimulation and orthosis triggering are only initiated when the BCI infers "on line" the presence of adequate SMRs or ERD/ERS within the epoch. That is, there is precise contingency between the efferent motor command and the afferent feedback induced by BCI-driven actuators (the patient feels he/she can move his upper limb when he wants to do it). Conversely, in the sham group, the any EEG signals of motor intention will be ignored and FES/orthosis triggering is decided at random. Each closed-loop BCI sub-movement epoch operates with a timeout of 2 seconds. In case the BCI detects no adequate SMR EEG correlates within this interval, the auditory cue commands an additional movement attempt and the epoch will be repeated as many times as needed.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
时间窗: Pre-intervention (1-2 days before intervention onset), immediately post-intervention and 6-month follow-up (at least 6 months after the end of the intervention)
Fugl-Meyer Assessment (FMA), upper limb department (FMA-UE) including reflexes (0-66 scale). The higher the FMA-UE outcome, the less the disability of the upper limb.
次要结局
- Medical Research Council (MRC) muscle strength(Pre-intervention (1-2 days before intervention onset), immediately post-intervention and 6-month follow-up (at least 6 months after the end of the intervention))
- Self-efficacy of daily living(Pre-intervention (1-2 days before intervention onset), immediately post-intervention and 6-month follow-up (at least 6 months after the end of the intervention))