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Rhythmic Auditory Stimulation Device for Stroke (OrcHESTRAS Trial)

N/A

Recruiting

Led By Francois Bethoux, MD

Research Sponsored by MedRhythms, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must be able to ambulate without assistance from another person. Note: assistive devices are allowed. If a participant uses an assistive device at the time of enrollment, the device must be used for all walking sessions.

Able to walk at a speed greater than or equal to 0.4 m/s as derived as an average of speed per minute from the 6MWT. Note: if a participant intends to use an assistive device throughout the intervention period, the assistive device must be used during the gait assessment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

OrcHESTRAS Trial Summary

This trial tests a device for stroke survivors to improve their walking using it at home and in their community.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since MR-001 involves rhythmic auditory stimulation for gait improvement after stroke, side effects are not typical as with medications; however, any discomfort or issues experienced during use will be monitored.

OrcHESTRAS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can walk on my own, but I may use a device like a cane or walker.

Select...

I can walk faster than 0.4 meters per second, even if I need to use an assistive device.

Select...

I am between 18 and 85 years old.

OrcHESTRAS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of walking sessions during 12-week intervention period

Secondary outcome measures

PROMIS Social Isolation Scale

Patient Health Questionnaire-8 (PHQ-8)

The Barthel Index

+1 more

Other outcome measures

6 Minute Walk Test (6MWT)

All-cause HCRU

All-cause hospitalizations and emergency department visits

+1 more

OrcHESTRAS Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cohort A: Restart InterventionExperimental Treatment1 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 WashoutActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MR-001

2019

N/A

~90

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

MedRhythms, Inc.Lead Sponsor

6 Previous Clinical Trials

238 Total Patients Enrolled

3 Trials studying Stroke

158 Patients Enrolled for Stroke

Francois Bethoux, MDPrincipal InvestigatorThe Cleveland Clinic

2 Previous Clinical Trials

454 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the current trial open to elderly participants?

"According to the trial's entry criteria, participants must be between 18 and 85 years of age. There are also 39 clinical trials for individuals younger than 18 and 1111 studies available for those aged over 65."

Answered by AI

Are enrollment opportunities currently available for this clinical trial?

"Affirmative. Clinicaltrials.gov's data reveals that this investigation, first announced on October 10th 2023, is presently recruiting patients. The total amount of participants required stands at 225 and recruitment will take place exclusively from a single site."

Answered by AI

How many participants are being sought for this research endeavor?

"Indeed, the data stored on clinicaltrials.gov reveals that this medical study is actively searching for participants. The first post was made by investigators in October 10th 2023 and the most recent update occurred on October 20th of the same year. To complete their research, 225 patients must be recruited from a single site."

Answered by AI

What criteria must participants fulfill in order to be eligible for enrollment into this trial?

"This clinical trial is recruiting 225 people aged between 18 and 85 years who have had a stroke. Primarily, individuals must be six months or more post-stroke with mobility issues, proficient in English, able to move without aid from another human being (although walking aids are allowed), willing to travel for assessment sessions as well as provide consent for their medical data to be shared. Furthermore, the speed of their ambulation needs to exceed 0.4 metres per second on average from the 6MWT test."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Outcomes and Health Economics of Stroke Using Rhythmic Auditory Stimulation

2023. "Outcomes and Health Economics of Stroke Using Rhythmic Auditory Stimulation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06051539.