An interventional study of BCI-NMES and Sham-NMES in Stroke, sponsored by University Hospital, Geneva. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by University Hospital, Geneva · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Electrical stimulation of paretic upper limb is triggered contigent to voluntary motor cortex activation of the patient, as detected by the brain-computer interface.
Device: BCI-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.
Device: Sham-NMES
From the recorded brain activity (EEG) subject specific patterns will be extracted with machine learning techniques from recordings where the subject executes movements tasks. Whenever a subject-specific pattern can be identified and detected, this is used for triggering neuromuscular electrical stimulation.
Neuromuscular electrical stimulation is triggered independently of the patient's movement intentions.
Change in Upper Limb Fugl-Meyer Score, after treatment
Scale 0-66, higher scores indicate better outcome
Time frame: Difference between the week before the intervention and the week after intervention
Change in motor evoked potential amplitude of the paretic arm
Continuous measure, higher amplitude changes indicate better outcome
Time frame: 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
FA can have values between 0 and 1, higher values indicate better outcome
Time frame: Difference between the week before the intervention and the week after intervention
Change in electroencephalography functional connectivity
Computed from high-density EEG recordings. Continuous measure. Higher values indicate better outcome.
Time frame: Difference between the week before the intervention and the week after intervention
Change in Upper Limb Fugl-Meyer Score, follow up
Scale 0-66, higher scores indicate better outcome
Time frame: Difference between the week before intervention and 12 weeks after stroke onset
Change in hand grip strength, after intervention
Jamar dynamometer. Continous measure expressed in kilograms. Higher values indicate better outcome.
Time frame: Difference between the week before the intervention and the week after intervention
Change in hand grip strength, follow up
Jamar dynamometer. Continous measure expressed in kilograms. Higher values indicate better outcome.
Time frame: Difference between the week before intervention and 12 weeks after stroke onset
Change in Functional Independence Measure (FIM) score, after intervention
Range 18-126, higher values indicate better outcome.
Time frame: Difference between the week before the intervention and the week after intervention
Change in Functional Independence Measure (FIM) score, follow up
Range 18-126, higher values indicate better outcome.
Time frame: Difference between the week before intervention and 12 weeks after stroke onset
Change in Semmes-Weinstein monofilament discrimination test, after intervention
Range 0.04 to 60 g. Lower values indicate better outcome.
Time frame: Difference between the week before the intervention and the week after intervention
Change in Semmes-Weinstein monofilament discrimination test, follow up
Range 0.04 to 60 g. Lower values indicate better outcome.
Time frame: Difference between the week before intervention and 12 weeks after stroke onset
Change in Modified Ashworth Score, after intervention
Range 0 to 4. Lower values indicate better outcome.
Time frame: Difference between the week before the intervention and the week after intervention
Change in Modified Ashworth Score, follow up
Range 0 to 4. Lower values indicate better outcome.
Time frame: Difference between the week before intervention and 12 weeks after stroke onset
Change in action research arm test (ARAT) score, after intervention
Scale range 0-57 points, higher values indicate better outcome.
Time frame: Difference between the week before the intervention and the week after intervention
Change in action research arm test (ARAT) score, follow up
Scale range 0-57 points, higher values indicate better outcome.
Time frame: Difference between the week before intervention and 12 weeks after stroke onset
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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University Hospital, Geneva