BCI-controlled NMES in Subacute Stroke

May 7, 2024 updated by: Adrian Guggisberg, University Hospital, Geneva

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Upper Limb Fugl-Meyer Score, after treatment
Time Frame: Difference between the week before the intervention and the week after intervention
Scale 0-66, higher scores indicate better outcome
Difference between the week before the intervention and the week after intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in motor evoked potential amplitude of the paretic arm
Time Frame: Difference between the week before the intervention and the week after intervention
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
Time Frame: Difference between the week before the intervention and the week after intervention
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
Time Frame: Difference between the week before the intervention and the week after intervention
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Upper Limb Fugl-Meyer Score, follow up
Time Frame: Difference between the week before intervention and 12 weeks after stroke onset
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
Time Frame: Difference between the week before the intervention and the week 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
Time Frame: Difference between the week before intervention and 12 weeks after stroke onset
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
Time Frame: Difference between the week before the intervention and the week 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
Time Frame: Difference between the week before intervention and 12 weeks after stroke onset
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
Time Frame: Difference between the week before the intervention and the week 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
Time Frame: Difference between the week before intervention and 12 weeks after stroke onset
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
Time Frame: Difference between the week before the intervention and the week 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
Time Frame: Difference between the week before intervention and 12 weeks after stroke onset
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
Time Frame: Difference between the week before the intervention and the week 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
Time Frame: Difference between the week before intervention and 12 weeks after stroke onset
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Geneva

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ecole Polytechnique Fédérale de Lausanne
Clinique Romande de Readaptation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 26, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 20, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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