Brain-computer Interface Controlled Neuromuscular Electrical Stimulation in Subacute Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Change in Upper Limb Fugl-Meyer Score, after treatment
研究概览
简要总结
Stroke patients with severe upper limb movement deficits have limited treatment options and often remain severely handicapped at the chronic stage.
Recent findings have suggested that poor motor recovery can be due to severe damage of the cortico-spinal tract (CST), the neural fibres connecting the movement regions of the brain to the spinal cord. Hence, to improve recovery of upper limb movements it will be crucial to re-establish and strengthen CST projections.
Recent studies provided evidence that closed-loop brain computer interface-driven electrical stimulation of the paretic muscles can induce clinically important and lasting recovery of upper limb function, even in patients with chronic, severe motor affection. In this treatment approach, movement intentions of the patients are detected with electroencephalography and real-time analyses. This triggers an electrical stimulation of affected upper limb muscles.
In this study, the investigators hypothesize that neuromuscular electrical stimulation (NMES) applied contingent to voluntary activation of primary motor cortex, as detected by a brain-computer interface (BCI), can help restore CST projections. This might improve recovery of patients with severe upper limb movement deficits. Treatment will be started within the first 8 weeks after stroke onset.
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
- •Ischemic or hemorrhagic stroke
- •Stroke onset ≤ 8 weeks
- •Severe, unilateral motor upper extremity hemiparesis (≤15 Fugl-Meyer Score)
- •Ability to give informed consent
排除标准
- •Second stroke during rehabilitation
- •Skull breach
- •Cardiac pacemaker
- •Metallic implants in the brain
- •Delirium or disturbed vigilance
- •Inability to follow treatments sessions
- •Severe language comprehension deficits
- •Severe dystonia or spasticity
- •Severe co-morbidity (ex, traumatic, rheumatologic, neurodegenerative diseases)
- •Pregnancy
研究组 & 干预措施
BCI-NMES
Electrical stimulation of paretic upper limb is triggered contigent to voluntary motor cortex activation of the patient, as detected by the brain-computer interface.
干预措施: BCI-NMES (Device)
Sham-NMES
Electrical stimulation of paretic upper limb is applied independently of motor cortex activation of the patient by using a prerecorded session of another patient.
干预措施: Sham-NMES (Device)
结局指标
主要结局
Change in Upper Limb Fugl-Meyer Score, after treatment
时间窗: Difference between the week before the intervention and the week after intervention
Scale 0-66, higher scores indicate better outcome
次要结局
- Change in motor evoked potential amplitude of the paretic arm(Difference between the week before the intervention and the week after intervention)
- Change in fractional anisotropy (FA) of the cortico-spinal tract as determined from diffusion tensor imaging(Difference between the week before the intervention and the week after intervention)
- Change in electroencephalography functional connectivity(Difference between the week before the intervention and the week after intervention)
研究者
Adrian Guggisberg
Médecin adjoint agrégé, assistant professor
University Hospital, Geneva