Wearable MCI for Stroke

Overseen By Cynthia Gorski

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Must not be taking: Spasticity treatments

Disqualifiers: Cognitive impairment, Visual impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

96 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are receiving new spasticity treatments, you may not be eligible to participate.

What data supports the effectiveness of the treatment MCI, Myoelectric-Computer Interface, MyoCI, MCI, Sham MCI, Placebo MCI, Control MCI for stroke?

Research shows that Myoelectric-Computer Interface (MCI) training can help stroke survivors improve arm function by reducing abnormal muscle coactivation, which is when muscles that should work independently contract together. Studies found that stroke survivors who used MCI training showed improvements in arm movement and function, suggesting it could be a promising treatment for stroke rehabilitation. ^{1 2 3 4 5}

Is the Myoelectric-Computer Interface (MCI) safe for humans?

The studies on Myoelectric-Computer Interface (MCI) training, primarily focused on stroke survivors, suggest that it is generally safe for humans. Participants, including both healthy individuals and those with stroke or spinal cord injury, were able to use the MCI without reported safety issues, and some even showed improvements in muscle function. ^{1 2 3 6 7}

How does the Myoelectric-Computer Interface (MCI) treatment for stroke differ from other treatments?

The Myoelectric-Computer Interface (MCI) treatment is unique because it uses a wearable device to map muscle signals to computer commands, helping retrain muscle activation patterns and reduce abnormal muscle coactivation after a stroke. This approach allows for high-dose, home-based training, which is not typically addressed by other therapies. ^{1 4 5 8 9}

What is the purpose of this trial?

The purpose of the study is to explore the feasibility of using a wearable device, called a myoelectric-computer interface (MCI), to improve arm movement in people who have had a stroke. Impaired arm movement after stroke is caused not just by weakness, but also by impaired coordination between joints due to abnormal co-activation of muscles. These abnormal co-activation patterns are thought to be due to abnormal movement planning.The MCI aims to reduce abnormal co-activation by providing feedback about individual muscle activations. This randomized, controlled, blinded study will test the home use of an MCI in chronic and acute stroke survivors.

Eligibility Criteria

This trial is for individuals who have had a stroke, either recently (within the past 21 days) or chronically (at least 6 months ago). Participants must have severe motor impairment but some ability to move their shoulder and elbow. They cannot be part of another study, have significant cognitive or visual impairments, new spasticity treatments, anesthesia in the arm, or substantial pain that would prevent daily participation.

Inclusion Criteria

I had a stroke over 6 months ago, have severe arm weakness but can still move my shoulder and elbow a bit.

I had my first stroke within the last 21 days and have severe arm weakness.

Exclusion Criteria

I have severe arm pain that stops me from participating in activities for 90 minutes a day.

I have a visual impairment that prevents me from seeing the whole screen.

You have trouble feeling or seeing on one side of your body due to a stroke.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the myoelectric-computer interface (MCI) to improve arm movement by reducing abnormal muscle co-activation

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• MCI
• Sham MCI

Trial Overview The study is testing a wearable device called an MCI designed to improve arm movement by reducing muscle co-activation issues caused by strokes. It's a randomized controlled trial where participants will use the MCI at home and their progress with arm movements will be monitored.

Participant Groups

Group I: Chronic stroke MCI while reaching Experimental Treatment 1 Intervention

Decoupling muscles with MCI while reaching to targets

Group II: Chronic stroke MCI Electromyogram (EMG) pairs Experimental Treatment 1 Intervention

Decoupling 2 muscles at a time with MCI

Group III: Chronic stroke MCI EMG triplets Experimental Treatment 1 Intervention

Decoupling 3 muscles at a time with MCI

Group IV: Acute stroke MCI Experimental Treatment 1 Intervention

Decoupling muscles with MCI in acute stroke subjects

Group V: Chronic stroke Sham MCI Placebo Group 1 Intervention

Sham control group

Group VI: Acute stroke Sham MCI Placebo Group 1 Intervention

Acute stroke subjects sham comparator

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Shirley Ryan AbilityLab

Collaborator

Trials

212

Recruited

17,900+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

Myoelectric computer interface (MCI) training effectively reduced abnormal muscle coactivation in both healthy participants and stroke survivors, indicating its potential as a rehabilitation tool.

Among the stroke survivors, 3 out of 5 showed a measurable improvement in arm function, as evidenced by a 3-point increase in the Fugl-Meyer Motor Assessment score, highlighting the efficacy of MCI in retraining muscle activation patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing Abnormal Muscle Coactivation After Stroke Using a Myoelectric-Computer Interface: A Pilot Study. Wright, ZA., Rymer, WZ., Slutzky, MW.[2021]

Myoelectric computer interface (MCI) training significantly reduced abnormal co-activation of arm muscles in 32 chronic stroke survivors, leading to improved arm function and kinematics after 6 weeks of training.

The benefits of MCI training persisted for at least one month after the training ended, indicating its potential as a lasting intervention for enhancing arm function post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of myoelectric computer interface training on arm kinematics and function after stroke. Tomic, G., Mugler, EM., Singh, A., et al.[2020]

A pilot study using a myoelectric-computer interface (MCI) showed that both healthy individuals and stroke survivors could learn to reduce muscle co-contraction, which is a barrier to improved motor function after a stroke.

Three out of five stroke survivors demonstrated some improvement in arm function after MCI training, indicating that this approach could be a promising and cost-effective method for stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Myoelectric computer interfaces to reduce co-contraction after stroke. Wright, ZA., Rymer, WZ., Slutzky, MW.[2021]

A study involving 23 severely impaired chronic stroke survivors demonstrated that home-based training using a novel myoelectric interface (MINT) was feasible, with participants training an average of 82 minutes per day over 6 weeks, showing high adherence and enjoyment of the therapy.

Participants not only improved their training performance but also reduced abnormal muscle co-activation, suggesting that MINT could effectively enhance arm function recovery in stroke survivors in a home setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable myoelectric interface enables high-dose, home-based training in severely impaired chronic stroke survivors. Hung, NT., Paul, V., Prakash, P., et al.[2022]

Brain-computer interfaces (BCIs) aim to translate brain signals into artificial outputs, potentially restoring or enhancing communication and control for individuals with neuromuscular disorders, but achieving high reliability and accuracy in these systems remains a significant challenge.

Effective BCI operation requires collaboration between the central nervous system (CNS) and the BCI itself, necessitating adaptive modifications in both systems to ensure accurate control, which is critical for real-world applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain-computer interfaces: Definitions and principles. Wolpaw, JR., Millán, JDR., Ramsey, NF.[2021]

The Myoelectric Computer Interface (MCI) developed in this study effectively helps individuals with spinal cord injury (SCI) reduce abnormal muscle activations, demonstrating its potential for promoting recovery of movement.

In tests with eight participants (six unimpaired and two with SCI), one SCI participant successfully decreased co-activation of arm muscles, while the other improved selective activation of leg muscles, indicating that the MCI can enhance awareness of muscular activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Myoelectric Computer Interface for Reducing Abnormal Muscle Activations after Spinal Cord Injury. Rizzoglio, F., Sciandra, F., Galofaro, E., et al.[2020]

A study involving 32 stroke survivors who underwent 6 weeks of MyoCI training showed that the training effectively reduced abnormal muscle co-activation in targeted arm muscles, leading to improved motor function.

While the overall number and composition of muscle synergies did not change significantly, the training increased the disparity of muscle weights within synergies for those who responded, indicating a more refined control of muscle coordination in the affected arm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Myoelectric interface training enables targeted reduction in abnormal muscle co-activation. Seo, G., Kishta, A., Mugler, E., et al.[2023]

The recoveriX system is a novel brain-computer interface designed specifically for stroke patients, aiming to enhance therapy by monitoring motor imagery in real-time.

Initial results from a single patient indicate that recoveriX can provide closed-loop feedback, potentially improving compliance and effectiveness of rehabilitation therapies for stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

recoveriX: a new BCI-based technology for persons with stroke. Irimia, D., Sabathiel, N., Ortner, R., et al.[2020]

In a study involving 36 patients with severe hemiparesis, the use of a brain-computer interface (BCI) significantly improved rehabilitation outcomes, as shown by an increase in Action Research Arm Test (ARAT) scores, compared to a control group.

In a follow-up study with 19 patients using a BCI-exoskeleton for motor imagery training, significant improvements in hand motor function were observed, with ARAT and Fugl-Meyer scale scores both showing marked increases, indicating the effectiveness of this combined approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Brain-Computer Interface: the First Clinical Experience in Russia]. Mokienko, OA., Lyukmanov, RKh., Chernikova, LA., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Reducing Abnormal Muscle Coactivation After Stroke Using a Myoelectric-Computer Interface: A Pilot Study. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

The effect of myoelectric computer interface training on arm kinematics and function after stroke. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Myoelectric computer interfaces to reduce co-contraction after stroke. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Wearable myoelectric interface enables high-dose, home-based training in severely impaired chronic stroke survivors. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Brain-computer interfaces: Definitions and principles. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

A Myoelectric Computer Interface for Reducing Abnormal Muscle Activations after Spinal Cord Injury. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Myoelectric interface training enables targeted reduction in abnormal muscle co-activation. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

recoveriX: a new BCI-based technology for persons with stroke. [2020]

9. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Brain-Computer Interface: the First Clinical Experience in Russia]. [2018]