BCI-controlled NMES in Subacute Stroke
- Conditions
- Stroke
- Interventions
- Device: BCI-NMESDevice: Sham-NMES
- Registration Number
- NCT03379532
- Lead Sponsor
- University Hospital, Geneva
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
- Ischemic or hemorrhagic stroke
- Stroke onset ≤ 8 weeks
- Severe, unilateral motor upper extremity hemiparesis (≤15 Fugl-Meyer Score)
- Ability to give informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BCI-NMES 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. Sham-NMES 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.
- Primary Outcome Measures
Name Time Method Change in Upper Limb Fugl-Meyer Score, after treatment Difference between the week before the intervention and the week after intervention Scale 0-66, higher scores indicate better outcome
- Secondary Outcome Measures
Name Time Method Change in motor evoked potential amplitude of the paretic arm Difference between the week before the intervention and the week after intervention Continuous measure, higher amplitude changes indicate better outcome
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 FA can have values between 0 and 1, higher values indicate better outcome
Change in electroencephalography functional connectivity Difference between the week before the intervention and the week after intervention Computed from high-density EEG recordings. Continuous measure. Higher values indicate better outcome.
Trial Locations
- Locations (2)
University of Austin
🇺🇸Austin, Texas, United States
Division of Neurorehabilitation, University Hospital of Geneva
🇨🇭Geneva, GE, Switzerland