Clinical trial NCT03379532: BCI-controlled NMES in Subacute Stroke
Official title: Brain-computer Interface Controlled Neuromuscular Electrical Stimulation in Subacute Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: Ecole Polytechnique Fédérale de Lausanne
name: Clinique Romande de Readaptation
First posted: 2017-12-20
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Ischemic or hemorrhagic stroke
* Stroke onset ≤ 8 weeks
* Severe, unilateral motor upper extremity hemiparesis (≤15 Fugl-Meyer Score)
* Ability to give informed consent

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Upper Limb Fugl-Meyer Score, after treatment
timeFrame: Difference between the week before the intervention and the week after intervention
Secondary outcomes:
measure: Change in motor evoked potential amplitude of the paretic arm
timeFrame: Difference between the week before the intervention and the week after intervention
measure: Change in fractional anisotropy (FA) of the cortico-spinal tract as determined from diffusion tensor imaging
timeFrame: Difference between the week before the intervention and the week after intervention
measure: Change in electroencephalography functional connectivity
timeFrame: Difference between the week before the intervention and the week after intervention
Other outcomes:
measure: Change in Upper Limb Fugl-Meyer Score, follow up
timeFrame: Difference between the week before intervention and 12 weeks after stroke onset
measure: Change in hand grip strength, after intervention
timeFrame: Difference between the week before the intervention and the week after intervention
measure: Change in hand grip strength, follow up
timeFrame: Difference between the week before intervention and 12 weeks after stroke onset
measure: Change in Functional Independence Measure (FIM) score, after intervention
timeFrame: Difference between the week before the intervention and the week after intervention
measure: Change in Functional Independence Measure (FIM) score, follow up
timeFrame: Difference between the week before intervention and 12 weeks after stroke onset
measure: Change in Semmes-Weinstein monofilament discrimination test, after intervention
timeFrame: Difference between the week before the intervention and the week after intervention
measure: Change in Semmes-Weinstein monofilament discrimination test, follow up
timeFrame: Difference between the week before intervention and 12 weeks after stroke onset
measure: Change in Modified Ashworth Score, after intervention
timeFrame: Difference between the week before the intervention and the week after intervention
measure: Change in Modified Ashworth Score, follow up
timeFrame: Difference between the week before intervention and 12 weeks after stroke onset
measure: Change in action research arm test (ARAT) score, after intervention
timeFrame: Difference between the week before the intervention and the week after intervention
measure: Change in action research arm test (ARAT) score, follow up
timeFrame: Difference between the week before intervention and 12 weeks after stroke onset
Locations:
city: Austin
country: United States
facility: University of Austin
state: Texas
city: Geneva
country: Switzerland
facility: Division of Neurorehabilitation, University Hospital of Geneva
state: GE
Study officials:
References: