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Neuromodulation Device

MyoRegulator® Device for Post-Stroke Muscle Spasms (RECOVER Trial)

N/A
Recruiting
Research Sponsored by PathMaker Neurosystems Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Willing to forgo upper extremity physical and occupational therapy for the duration of the study (lower extremity PT and OT are allowed)
First single focal unilateral hemisphere lesion with diagnosis verified by brain imaging (MRI or CT scans) that occurred at least 6 months prior to study enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 weeks post-treatment
Awards & highlights

RECOVER Trial Summary

This trial will compare the effects of a new device called the MyoRegulator®, which uses electrical stimulation, to a sham device in stroke patients with upper-extremity spasticity. The study will last for 5 days, and safety and performance of the MyoRegulator® will be assessed.

Who is the study for?
This trial is for stroke survivors aged 18-84 with upper limb spasticity, who haven't had certain muscle treatments recently. They must understand the study and avoid specific therapies during the trial. Exclusions include severe muscle issues, recent use of excluded drugs or procedures, other CNS impairments, risk factors for electrical stimulation, or pregnancy.Check my eligibility
What is being tested?
The MyoRegulator® device is being tested in this study to see if it can help reduce muscle spasms after a stroke. Patients are randomly assigned to receive either active treatment or a sham (fake) treatment over five days while both they and the evaluator don't know which one they're getting.See study design
What are the potential side effects?
Since MyoRegulator® is non-invasive and considered low-risk, side effects may be minimal but could include skin irritation at the site of stimulation or discomfort during use. The full range of potential side effects will be monitored throughout the study.

RECOVER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree not to undergo arm therapy while in the study.
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I have one brain lesion, confirmed by MRI or CT, diagnosed over 6 months ago.
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I agree not to use certain muscle treatments or specific drugs during the study.
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My arm stiffness has been stable for 6 weeks and is moderately severe.
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I am between 18 and 84 years old.
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I can understand and follow the study's instructions.
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I agree to keep taking my current spasticity and neurotransmitter medications during the study.

RECOVER Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 weeks post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 weeks post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Muscle Spasticity
Secondary outcome measures
Change in Modified Ashworth Scale total upper limb score following 5 days of treatment as compared to baseline
Change in Modified Tardieu Scale total upper limb score following 5 days of treatment as compared to baseline
Therapeutic procedure
+3 more

RECOVER Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active StimulationExperimental Treatment1 Intervention
Five consecutive days of 20 minutes active stimulation with MyoRegulator® device
Group II: Sham StimulationPlacebo Group1 Intervention
Five consecutive days of 20 minutes sham stimulation with MyoRegulator® device

Find a Location

Who is running the clinical trial?

PathMaker Neurosystems Inc.Lead Sponsor
3 Previous Clinical Trials
75 Total Patients Enrolled
Spaulding Rehabilitation HospitalOTHER
133 Previous Clinical Trials
10,947 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,337 Previous Clinical Trials
648,768 Total Patients Enrolled

Media Library

MyoRegulator® device (Neuromodulation Device) Clinical Trial Eligibility Overview. Trial Name: NCT04742257 — N/A
Muscle Spasms Research Study Groups: Active Stimulation, Sham Stimulation
Muscle Spasms Clinical Trial 2023: MyoRegulator® device Highlights & Side Effects. Trial Name: NCT04742257 — N/A
MyoRegulator® device (Neuromodulation Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04742257 — N/A

Frequently Asked Questions

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

Are senior citizens above the age of 85 eligible for this experiment?

"The age range for this clinical trial spans from 18 to 85 years old."

Answered by AI

What is the endgame of this medical experiment?

"The primary outcome of this clinical trial, monitored over a 2-6 week period after the treatment has been administered, is to observe any fluctuations in wrist flexor spasticity when compared to the baseline as evaluated by the Modified Ashworth Scale score. Secondary outcomes include changes in Upper-Extremity Fugl-Meyer motor domain scores from prior and post 5 treatments up to 3 months later; alterations in Modified Tardieu Scale total upper limb score following 5 days of treatment comparably with its pre-treatment state; and lastly shifts in Modified Ashworth Scale total upper limb score also following 5 days of therapy relative to its"

Answered by AI

To whom is this clinical trial open for enrolment?

"This trial is recruiting 76 individuals aged 18-85 that have experienced a stroke. To qualify for the study, patients must satisfy several criteria such as having stable spasticity symptoms with a Modified Ashworth Scale score of 1+ to 3 (on the 0, 1, 1+, 2, 3, 4 scale), being willing to abstain from certain treatments and therapies during their participation in the study; demonstrating sufficient cognitive function; and presenting evidence of a single focal unilateral hemisphere lesion verified by brain imaging at least 6 months prior to enrollment."

Answered by AI

Are there vacancies available in this clinical trial?

"According to the online resources of clinicaltrials.gov, this medical trial is currently seeking enrolment from volunteers. It was initially posted on March 4th 2022 and has been revised more recently on July 22nd 2022."

Answered by AI

What is the current enrolment number for this clinical trial?

"Affirmative. Clinicaltrials.gov signifies that this research trial, which was originally published on March 4th 2022 is actively recruiting individuals to participate. Currently, 76 participants must be enlisted across two different medical centres."

Answered by AI
~30 spots leftby Jul 2025