Rhythmic Auditory Stimulation Device for Stroke

(OrcHESTRAS Trial)

Overseen By Sabrina Taylor, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MedRhythms, Inc.

Disqualifiers: Hearing impairment, Pain, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness and practicality of a device called MR-001 for individuals who have difficulty walking due to a stroke. Participants will either use the device at home for walking exercises or continue without it to compare results. It suits individuals living with a chronic stroke who can walk independently but may use devices like canes or walkers. The goal is to determine how this rhythmic auditory stimulation device might improve walking and reduce the need for other healthcare resources.

As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance rehabilitation options for stroke survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

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

Research has shown that MR-001, a device using sound to aid movement, is safe for stroke recovery. In earlier studies, individuals who had a stroke some time ago used the device safely at home. They walked better without major safety issues. Users have not reported serious side effects, suggesting that MR-001 is well-tolerated by those who have tried it. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MR-001 device for stroke rehabilitation because it offers a unique approach through rhythmic auditory stimulation. Unlike traditional physical therapy or medication-based treatments, MR-001 integrates auditory cues into walking exercises, potentially enhancing motor recovery and coordination. This method not only makes the rehabilitation process more engaging but also allows patients to perform exercises in their home environment, promoting convenience and consistency in therapy. By tapping into the brain's natural response to rhythm, MR-001 could accelerate recovery, offering hope for improved outcomes in stroke survivors.

What evidence suggests that the MR-001 device is effective for improving gait in stroke patients?

Research has shown that rhythmic auditory stimulation (RAS) can help stroke patients improve their walking and balance. Studies have found that RAS makes walking faster, more rhythmic, and more balanced. As a result, patients often walk more steadily and quickly after using RAS. In this trial, participants in Cohort A will use the MR-001 device for RAS during active walking sessions. Early results suggest that RAS could be a strong tool in helping patients regain movement skills. Overall, evidence supports RAS as an effective way to aid stroke recovery. ^{2 5 6 7 8}

Who Is on the Research Team?

Francois Bethoux, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 who had a stroke at least 6 months ago and now have trouble walking. They must be able to walk on their own (with devices if needed), speak English, and agree to share health data. People with severe hearing loss, pain affecting walking, recent major surgery, or conditions like Parkinson's can't join.

Inclusion Criteria

Must have claims data available and consent to sharing.

I am willing to travel for gait assessments.

It's been over 6 months since my stroke, and I have trouble walking.

Exclusion Criteria

Unable or unwilling to provide informed consent to participate

You have trouble hearing, even with a hearing aid, and cannot hear the beat of music.

You are pregnant or may become pregnant because it can affect how you walk.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the MR-001 device for walking therapy at least 3 times a week for 12 weeks in their home/community environment

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of healthcare resource utilization

40 weeks

Continued Washout

Participants in Cohort B continue their washout period for another 24 weeks

24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MR-001

Trial Overview

The study tests MR-001's ability to improve walking in chronic stroke patients when used at home or in the community. It looks at how well people stick with it, its effectiveness over time, and its impact on healthcare costs.

How Is the Trial Designed?

Group I: Cohort A: Restart Intervention Experimental Treatment 1 Intervention

Participants in Cohort A will perform active walking for 30 minutes at a time with MR-001, at least 3 times a week, for 12 weeks in their home/community environment.

Group II: Cohort B: Continued Washout Active Control 1 Intervention

Participants in Cohort B will continue their washout period for another 24 weeks.

Who Is Running the Clinical Trial?

MedRhythms, Inc.

Lead Sponsor

Trials

7

Recruited

440+

Published Research Related to This Trial

Rhythmic auditory stimulation (RAS) significantly improves motor function and balance in stroke patients, with notable enhancements in gait parameters such as step length, cadence, and walking velocity, based on a meta-analysis of 18 studies involving various outcome measures.

While RAS shows promise in enhancing balance ability, the evidence is less robust, indicating a need for further research to strengthen findings in this area, as only a limited number of studies focused on balance outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of rhythmic auditory stimulation on motor function and balance ability in stroke: A systematic review and meta-analysis of clinical randomized controlled studies. Wang, L., Peng, JL., Xiang, W., et al.[2023]

In a study involving three chronic stroke patients, Music-Supported Therapy was found to enhance auditory-motor interaction, as indicated by similar neural beta-band activity during both listening and motor tasks.

Post-training assessments showed a significant decrease in beta activity after tone onset and improvements in arm and hand skills, suggesting that music-based rehabilitation can effectively support motor recovery in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in neuromagnetic beta-band oscillation after music-supported stroke rehabilitation. Fujioka, T., Ween, JE., Jamali, S., et al.[2016]

This pilot study aims to assess the feasibility of using auditory rhythmic cueing (ARC) to improve mobility in stroke survivors, with 60 participants recruited over 15 months from community stroke services in North East England.

Participants will engage in 18 ARC treatment sessions over 6 weeks, and the study will evaluate recruitment, retention, and the effectiveness of ARC in enhancing gait and balance, providing valuable insights for a future larger trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auditory rhythmical cueing to improve gait and physical activity in community-dwelling stroke survivors (ACTIVATE): study protocol for a pilot randomised controlled trial. McCue, P., Del Din, S., Hunter, H., et al.[2022]

Citations

1.

researchsquare.com

researchsquare.com/article/rs-7725504/v1.pdf?c=1761908171000

Outcomes and Health Economics of Stroke using Rhythmic ...

Rhythmic auditory stimulation (RAS) is a validated technique that enhances gait parameters, including speed, cadence, and stride symmetry in ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12426047/

Integrating rhythmic auditory stimulation in intelligent ...

By combining RAS with robotic and VR-based interventions, we propose a novel framework for enhancing motor and cognitive recovery after stroke.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06051539

Outcomes and Health Economics of Stroke Using Rhythmic ...

The purpose of this trial is to assess engagement, efficacy, durability, and impact on health care resource utilization of MR-001 in persons with chronic stroke ...

4.

frontiersin.org

frontiersin.org/journals/bioengineering-and-biotechnology/articles/10.3389/fbioe.2025.1649011/full

Integrating rhythmic auditory stimulation in intelligent ...

RAS holds great potential for enhancing neurorehabilitation after stroke. The strongest evidence for the efficacy of RAS interventions has been ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10799424/

The effects of rhythmic auditory stimulation on functional ...

The most consistent finding was that RAS improves walking and balance parameters in stroke patients in all phases compared to baseline and versus control groups ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10853163/

Efficacy and safety of using auditory-motor entrainment to ...

The auditory-motor intervention autonomously delivered by InTandem is safe and effective in improving walking in the chronic phase of stroke.

7.

rehab.jmir.org

rehab.jmir.org/2023/1/e50438

Validating the Safe and Effective Use of a Neurorehabilitation ...

To help close this gap, MedRhythms has designed MR-001 (InTandem, MedRhythms, Inc), a neurorehabilitation system that delivers a RAS-based ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10696501/

Validating the Safe and Effective Use of a ...

In this validation study, people in the chronic phase of stroke recovery were able to safely and effectively use InTandem in the intended use environment.