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| Name | Class |
|---|---|
| Ecole Polytechnique Fédérale de Lausanne | OTHER |
| Clinique Romande de Readaptation | NETWORK |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BCI-NMES | Active Comparator | 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 Comparator | Electrical stimulation of paretic upper limb is applied independently of motor cortex activation of the patient by using a prerecorded session of another patient. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCI-NMES | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Upper Limb Fugl-Meyer Score, after treatment | Scale 0-66, higher scores indicate better outcome | Difference between the week before the intervention and the week after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in motor evoked potential amplitude of the paretic arm | Continuous measure, higher amplitude changes indicate better outcome | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Upper Limb Fugl-Meyer Score, follow up | Scale 0-66, higher scores indicate better outcome | Difference between the week before intervention and 12 weeks after stroke onset |
| Change in hand grip strength, after intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Austin | Austin | Texas | 78712 | United States | ||
| Division of Neurorehabilitation, University Hospital of Geneva |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Sham-NMES | Device | Neuromuscular electrical stimulation is triggered independently of the patient's movement intentions. |
|
FA can have values between 0 and 1, higher values indicate better outcome |
| 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. | Difference between the week before the intervention and the week after intervention |
Jamar dynamometer. Continous measure expressed in kilograms. Higher values indicate better outcome.
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Difference between the week before intervention and 12 weeks after stroke onset |
| Geneva |
| Canton of Geneva |
| 1211 |
| Switzerland |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |