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
- 入组人数
- 32
- 试验地点
- 1
- 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
- •More than 18 years of age
- •Victim of ischemic or haemorrhagic cerebrovascular accident (CVA)
- •At least 6 months since occurrence of CVA. No upper limit on time since stroke is imposed
- •First CVA
- •Severe central paresis or complete paralysis of the upper limb, as quantified by a Medical Research Council (MRC) scale score ≤2 evaluated at the wrist and finger extension and flexion, and forearm flexion and extension Other concomitant motor disabilities do not constitute
排除标准
- •Unilateral cortical lesions (left or right hemisphere), subcortical lesions or supra-pontic lesions of the corticospinal tract having caused paralysis of the upper limb as documented by radiologic evidence
- •Adequate or corrected vision
- •Exclusion criteria:
- •Any reason obstructing EEG acquisition (scalp infections or wounds, dermatitis, etc)
- •Severe concomitant diseases (fever, infections, cardiac conditions, etc)
- •Heavy medication affecting the central nervous system (CNS, especially vigilance)
- •CVA with multiple infarcts
- •Second or later CVA
- •Severe unilateral hemispatial neglect as assessed by the behavioural part of the Behavioural Inattention Test (BIT) and the Fluff Test for body neglect
- •Severe cognitive disability affecting speech production, communication (e.g. aphasia), the ability to understand and give clear and free informed consent and to fully understand and comply with protocol instructions. A score of above 22/30 of the Montreal Cognitive Assessment (MoCA) scale is advised Inability to concentrate for 2 consecutive hours
- •Concomitant neurological conditions (e.g. Parkinson's disease) Severe spasticity. The Modified Ashworth Scale (MAS) score at the elbow, wrist and fingers should be below or equal to
- •Severe dystonia, dyskinesia or pain
- •Cardiac pacemaker, active implants and other contraindications for FES
- •Metallic implants affecting EEG acquisition
- •Patients for whom it is not possible to evoke a MEP greater than or equal to 0.2 mV amplitude at rest from the FDI and more proximal muscles (like ECR, FDS, etc) of the affected limb, or with contraindications for the TMS or Diffusion Tensor Imaging (DTI) protocols, will not undergo the respective procedures but will not be excluded from the trial.
研究组 & 干预措施
Brain-computer interface (BCI)
In the BCI arm, FES stimulation and orthosis triggering are only initiated when the BCI infers "on line" (in real time) 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).
干预措施: EEG-based brain-computer interface (Combination Product)
Brain-computer interface (BCI)
In the BCI arm, FES stimulation and orthosis triggering are only initiated when the BCI infers "on line" (in real time) 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).
干预措施: Functional Electrical Stimulation (Device)
Brain-computer interface (BCI)
In the BCI arm, FES stimulation and orthosis triggering are only initiated when the BCI infers "on line" (in real time) 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).
干预措施: Active hand orthosis (Device)
Sham-Brain-computer interface (Sham-BCI)
In the Sham-BCI group, any EEG signals encoding motor intention of the patient are ignored. FES/orthosis triggering is decided at random, by "playing back" the data of a randomly selected run of a previously recruited participant. Hence, in the Sham-BCI arm, there is no guaranteed contingency between the efferent motor command and the afferent feedback induced by the FES and the orthosis, although it can still happen by coincidence.
干预措施: Active hand orthosis (Device)
Sham-Brain-computer interface (Sham-BCI)
In the Sham-BCI group, any EEG signals encoding motor intention of the patient are ignored. FES/orthosis triggering is decided at random, by "playing back" the data of a randomly selected run of a previously recruited participant. Hence, in the Sham-BCI arm, there is no guaranteed contingency between the efferent motor command and the afferent feedback induced by the FES and the orthosis, although it can still happen by coincidence.
干预措施: Sham EEG-based brain-computer interface (Combination Product)
Sham-Brain-computer interface (Sham-BCI)
In the Sham-BCI group, any EEG signals encoding motor intention of the patient are ignored. FES/orthosis triggering is decided at random, by "playing back" the data of a randomly selected run of a previously recruited participant. Hence, in the Sham-BCI arm, there is no guaranteed contingency between the efferent motor command and the afferent feedback induced by the FES and the orthosis, although it can still happen by coincidence.
干预措施: Functional Electrical Stimulation (Device)
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))