BCI-controlled NMES in Subacute Stroke

NCT03379532 | Completed FDA Device

• 1 other identifier: CRSII5-170985B
• Study Type: interventional
• Target: 31
• Locations: 2 countries
• Sites: 2

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in motor evoked potential amplitude of the paretic arm

  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

  Difference between the week before the intervention and the week after intervention

• Change in electroencephalography functional connectivity

  Difference between the week before the intervention and the week after intervention

Other Outcomes (11)

• Change in Upper Limb Fugl-Meyer Score, follow up

  Difference between the week before intervention and 12 weeks after stroke onset

• Change in hand grip strength, after intervention

  Difference between the week before the intervention and the week after intervention

• Change in hand grip strength, follow up

  Difference between the week before intervention and 12 weeks after stroke onset

Study Arms (2)

BCI-NMES

ACTIVE COMPARATOR

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

Sham-NMES

SHAM COMPARATOR

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

Interventions

BCI-NMES DEVICE

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.

BCI-NMES

Sham-NMES DEVICE

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

Sham-NMES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University Hospital, Geneva: lead
• Ecole Polytechnique Fédérale de Lausanne: collaborator
• Clinique Romande de Readaptation: collaborator

Study Sites (2)

University of Austin

Austin, Texas, 78712, United States

Location

Division of Neurorehabilitation, University Hospital of Geneva

Geneva, Canton of Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Médecin adjoint agrégé, assistant professor

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: December 20, 2017
• Study Start: January 26, 2018
• Primary Completion: March 31, 2024
• Study Completion: April 30, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

US (1); CH (1)