NCT03379532

BCI-controlled NMES in Subacute Stroke

Brain-computer Interface Controlled Neuromuscular Electrical Stimulation in Subacute Stroke

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: University Hospital, Geneva · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	BCI-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.
DEVICE	Sham-NMES	Neuromuscular electrical stimulation is triggered independently of the patient's movement intentions.

Timeline

• Start date: 2018-01-26
• Primary completion: 2024-03-31
• Completion: 2024-04-30
• First posted: 2017-12-20
• Last updated: 2024-05-08

Locations

2 sites across 2 countries: United States, Switzerland

Regulatory

• FDA-regulated device study