BCI-controlled NMES in Subacute Stroke

Completed · Not applicable · Has a placebo group

Conditions studied: Stroke

In brief

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.

Key facts

Study ID

NCT03379532

Run by

University Hospital, Geneva

People needed

31

Starts

2018-01-26

Expected to finish

2024-04-30

Last updated by the study team

2024-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• University of Austin — Austin, Texas, United States
• Division of Neurorehabilitation, University Hospital of Geneva — Geneva, Canton of Geneva, Switzerland

Full record on ClinicalTrials.gov

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