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

234 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests the MR-001 device, which helps stroke patients improve their walking using rhythmic sounds. It targets adults with chronic stroke who have trouble walking. The device tracks steps and adjusts therapy automatically to aid in walking improvement.

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 data supports the effectiveness of the treatment MR-001 for stroke?

Research shows that rhythmic auditory stimulation (RAS), which is similar to the MR-001 treatment, can improve motor functions, balance, and walking abilities in stroke patients. This suggests that MR-001 might also be effective in helping stroke survivors regain movement and balance. ^{1 2 3 4 5}

Is the Rhythmic Auditory Stimulation Device safe for humans?

The studies on Rhythmic Auditory Stimulation (RAS) for stroke and Parkinson's disease suggest it is generally safe, as they focus on its effectiveness in improving motor functions and gait without reporting significant safety concerns. ^{1 2 5 6 7}

How does the Rhythmic Auditory Stimulation Device treatment for stroke differ from other treatments?

The Rhythmic Auditory Stimulation (RAS) treatment is unique because it uses rhythmic sounds to improve motor function and balance in stroke patients by engaging both the auditory and sensorimotor systems, unlike traditional therapies that may not incorporate auditory elements. ^{1 2 4 7 8}

Research Team

Francois Bethoux, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Rhythmic Auditory Stimulation as an Adjuvant Therapy Improved Post-stroke Motor Functions of the Upper Extremity: A Randomized Controlled Pilot Study. [2023]

2. Switzerland 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. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of rhythmic auditory stimulation on gait and balance in hemiplegic stroke patients. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

The Effect of Music-Based Rhythmic Auditory Stimulation on Balance and Functional Outcomes after Stroke. [2022]

5. England 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. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Rhythmic auditory-motor entrainment improves hemiparetic arm kinematics during reaching movements: a pilot study. [2016]

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

Design and development of a gait training system for Parkinson's disease. [2019]

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

Changes in neuromagnetic beta-band oscillation after music-supported stroke rehabilitation. [2016]