BCI-controlled NMES in Subacute Stroke

NCT ID: NCT03379532

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-26
• Study Completion Date: 2024-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

BCI-NMES

Intervention Type: 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.

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.

Group Type: SHAM_COMPARATOR

Sham-NMES

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Sham-NMES

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ecole Polytechnique Fédérale de Lausanne

OTHER

Sponsor Role: collaborator

Clinique Romande de Readaptation

NETWORK

Sponsor Role: collaborator

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Adrian Guggisberg

Médecin adjoint agrégé, assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Austin

Austin, Texas, United States

Division of Neurorehabilitation, University Hospital of Geneva

Geneva, Canton of Geneva, Switzerland

Countries

United States; Switzerland

Other Identifiers

CRSII5-170985B

Identifier Type: -

Identifier Source: org_study_id