BCI-controlled NMES in Subacute Stroke

Stroke Clinical Trial

Official title:

Brain-computer Interface Controlled Neuromuscular Electrical Stimulation in Subacute Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03379532
• Other study ID #: CRSII5-170985B
• Status: Completed
• Phase: N/A
• Start date: January 26, 2018
• Est. completion date: April 30, 2024

Study information

• Verified date: May 2024
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: April 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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-NMES
Neuromuscular electrical stimulation is triggered independently of the patient's movement intentions.

Locations

Country	Name	City	State
Switzerland	Division of Neurorehabilitation, University Hospital of Geneva	Geneva	GE
United States	University of Austin	Austin	Texas

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Geneva	Clinique Romande de Readaptation, Ecole Polytechnique Fédérale de Lausanne

Countries where clinical trial is conducted

United States,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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