BCI-controlled NMES in Subacute Stroke

Brain-computer Interface Controlled Neuromuscular Electrical Stimulation in Subacute Stroke

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: BCI-NMES; Device: Sham-NMES

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • GE
    • Geneva, GE, Switzerland, 1211
      • Division of Neurorehabilitation, University Hospital of Geneva
• United States
  • Texas
    • Austin, Texas, United States, 78712
      • University of Austin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BCI-NMES; 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; 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.
Sham Comparator: Sham-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; Neuromuscular electrical stimulation is triggered independently of the patient's movement intentions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Collaborators: Ecole Polytechnique Fédérale de Lausanne; Clinique Romande de Readaptation

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2018
• Primary Completion (Actual): March 31, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: December 14, 2017
• First Submitted That Met QC Criteria: December 14, 2017
• First Posted (Actual): December 20, 2017

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: CRSII5-170985B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes