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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a wearable device called a myoelectric-computer interface (MCI) to improve arm movement in stroke survivors. The device provides feedback on muscle movements to reduce abnormal coordination. Participants will include stroke survivors with significant arm movement issues, whether from a recent stroke or one that occurred over six months ago. The trial will compare different methods of using the MCI and will include a control group for comparison. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance rehabilitation options for stroke survivors.

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 prior data suggests that this wearable device is safe for stroke patients?

Research has shown that the myoelectric-computer interface (MCI) is generally well-tolerated by stroke survivors. Studies have found that it helps reduce abnormal muscle movements, improving arm movement. This means the MCI can help decrease issues like stiffness and poor coordination in the arm muscles.

In previous tests with stroke survivors, the MCI did not cause serious side effects. Participants used the device at home without major issues. The studies included individuals who had a recent stroke and those with long-term effects, and the results were similar for both groups. Overall, the MCI appears to be a safe option for improving arm function after a stroke. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they use a novel approach called Muscle Coordination Interface (MCI) to help stroke patients regain muscle control. Unlike traditional therapies focusing on physical exercises or medications, MCI technology aims to 'decouple' muscles, allowing patients to improve movement precision by targeting specific muscle groups one, two, or three at a time. This precision targeting could lead to more effective rehabilitation, potentially speeding up recovery and improving outcomes for both acute and chronic stroke patients. Additionally, the wearable nature of MCI provides a unique and potentially more convenient method for ongoing treatment outside of clinical settings.

What evidence suggests that this wearable device is effective for improving arm movement after a stroke?

Research has shown that a myoelectric-computer interface (MCI) can help stroke survivors improve arm movement by reducing unusual muscle activity. In one study, stroke survivors using MCI training reduced this abnormal muscle activity by 99%. This reduction can enhance coordination and control of movement. Another study found that incorporating MCI into a training program improved function in individuals with long-term stroke effects. The technology provides feedback on muscle use, aiding in retraining the brain and muscles for better movement.

In this trial, participants will be assigned to different treatment arms to evaluate MCI's effectiveness. Some participants will receive MCI interventions, such as decoupling muscles with MCI while reaching or using electromyogram (EMG) pairs or triplets. Others will be in a sham control group, receiving Sham MCI, to compare outcomes. These findings suggest MCI could be a promising tool for enhancing recovery after a stroke. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6611547/

Myoelectric Computer Interface Training for Reducing Co ... In a pilot study, chronic stroke survivors used MyoCI training of a single muscle pair (biceps and anterior deltoid) to reduce abnormal co-activation by 99% ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03401762

Wearable MCI to Reduce Muscle Co-activation in Acute ... This randomized, controlled, blinded study will test the home use of an MCI in chronic and acute stroke survivors. Official Title. Wearable MCI to Reduce Muscle ...

3. ahajournals.org ahajournals.org/doi/10.1161/str.52.suppl_1.P206

Abstract P206: Wearable Myoelectric Interface Training for ... Here, we describe a novel, wearable version of the MyoCI to control custom-designed computer games as a home-based therapy for chronic stroke ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30888251/

Myoelectric Computer Interface Training for Reducing Co ... MyoCI is a well-tolerated, novel rehabilitation tool that enables stroke survivors to reduce abnormal co-activation. It may reduce impairment and spasticity ...

5. medrxiv.org medrxiv.org/content/10.1101/2023.12.14.23299812v1

Combining muscle-computer interface guided training with ... Our study showed that the training paradigm could lead to functional improvement in chronic stroke patients. We argue that an appropriate MCI ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/acn3.51442

Wearable myoelectric interface enables high‐dose, home‐ ... We designed and tested a novel, wearable, high-dose, home-based therapy to reduce abnormal co-activation in chronic stroke survivors.

7. researchgate.net researchgate.net/publication/328991075_The_effect_of_myoelectric_computer_interface_training_on_arm_kinematics_and_function_after_stroke

The effect of myoelectric computer interface training on arm ... Here, we evaluated the effects of MCI training on function and arm kinematics in 32 chronic stroke survivors. We compared the effects of ...