Study Evaluating MyoRegulator® Treatment in Post-Stroke Upper Limb Spasticity (RECOVER)

November 28, 2023 updated by: PathMaker Neurosystems Inc.

Multi-Center, Randomized, Sham-Controlled Study Evaluating MyoRegulator® Treatment in Post-Stroke Upper Limb Spasticity

This is a multi-center, randomized, double-blind (patient and evaluator), sham-controlled study to be conducted in stroke patients with upper-extremity spasticity. The main objectives of this study are to evaluate the performance and safety of the MyoRegulator® device in active- versus sham-treated patients after 5 consecutive days of treatment. The MyoRegulator® device is a non-significant risk (NSR) investigational non-invasive neuromodulation device that uses multi-site direct current (multi-site DCS) stimulation for the treatment of muscle spasticity.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Stroke is the fifth leading cause of death in the U.S. and a leading cause of serious long-term disability. There are over 7.5 million patients in the U.S. living with stroke, and an estimated 795,000 additional cases of stroke occur annually in the U.S. Of these cases, approximately 610,000 represent initial attacks and 185,000 represent recurrent stroke according to the CDC.

Spasticity is a common finding in patients with stroke, arising in about 30% of stroke patients, and occurring usually within the first few days or weeks. It is a disorder of motor function that results from injury to the spinal cord or brain, and causes decreased motor performance as well as pain, discomfort and muscle weakness that greatly interferes with functional recovery. Spasticity can range from mild to severe and can cause striking impairments in functional movement.

An initial clinical trial of safety and feasibility suggests that five sessions of treatment with the MyoRegulator® device temporarily reduces spasticity and overall stiffness of the affected extremity with optimal reductions in spasticity occurring 2-3 weeks post stimulation intervention.

MyoRegulator® is a non-significant risk (NSR) investigational non-invasive neuromodulation device using multi-site direct current stimulation (multi-site DCS) for the treatment of spasticity. Multi-site DCS utilizes trans-spinal direct current stimulation (tsDCS) paired with transcutaneous peripheral direct current stimulation (pDCS). This study was designed to evaluate the efficacy and safety of MyoRegulator® in the treatment of post-stroke upper-limb spasticity.

The primary performance endpoint is defined as the reduction in wrist joint spasticity as measured using the Modified Ashworth Scale and will use a responder analysis. The study will be considered to have a successful outcome if a significant number of actively treated subjects respond to MyoRegulator® treatment as compared to the sham treated subjects following 5 days of treatment.

The primary safety endpoint is defined as the incidence of device-related serious adverse events. The safety of the device will be demonstrated if there are no incidents of serious adverse events caused or contributed to by the device treatment that are clinically unacceptable in light of the treatment benefits.

In order to evaluate the relationship between response to treatment and BDNF genotype, subjects will be asked to provide a saliva sample and give consent for BDNF genotyping.

Study Type

Interventional

Enrollment (Estimated)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02138
        • Recruiting
        • Spaulding Rehabilitation Hospital
        • Contact:
      • Charlestown, Massachusetts, United States, 02114
        • Recruiting
        • Spaulding Rehabilitation Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ≥ 18 to < 85 years of age
  • 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
  • At least 6 weeks of stable UE spasticity symptoms (as confirmed by medical history) with a baseline Modified Ashworth Scale (MAS) score of 1+ to 3 (on the 0, 1, 1+, 2, 3, 4 scale), inclusive, in the wrist flexor muscles
  • Willing to forgo botulinum toxin, phenol or alcohol injections into the muscles of the limb targeted for the study treatment; intrathecal baclofen; digitalis, and morphine for the subject's duration in the study
  • Willing to forgo upper extremity physical and occupational therapy for the duration of the study (lower extremity PT and OT are allowed)
  • Willing to maintain current regiment for oral spasticity medication(s) and neurotransmitter medication(s) for the subject's duration in the study
  • Cognitive function sufficient to understand the experiments and follow instructions (per interview with appropriate clinician)

Exclusion Criteria:

  • Fixed contractures or profound muscle atrophy of the target spastic wrist to be treated
  • Change in antispastic oral medication (baclofen, clonidine, benzodiazepine, dantrolene, gabapentin, tizanidine) in the 2 months prior to study enrollment
  • Use of digitalis, morphine, or intrathecal pump in the week prior to study enrollment
  • Prior botulinum toxin injection(s) into the muscles of the limb targeted for the study treatment within 12 weeks of study enrollment
  • Prior phenol or alcohol injections into the muscles of the limb targeted for the study treatment within 6 months of study enrollment
  • Prior surgery for spasticity in the target muscle group
  • Prior transcranial or trans-spinal direct current stimulation for any reason

  • Presence of potential tsDCS risk factors:

    • Damaged skin at the stimulation sites (i.e., skin with ingrown hairs, acne, razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc.)
    • Lack of sensory perception at the stimulation sites
    • Presence of an electrically, magnetically, or mechanically activated implant (including cardiac pacemaker) or any other electrically sensitive support system with the exception of loop recorders
    • Ferrous metal in the path of the current flow (jewelry must be removed during stimulation)
    • Past history of epileptic seizures or unexplained spells of loss of consciousness during the previous 36 months
  • Other neurological conditions involving CNS impairment, including Parkinson's Disease, Multiple Sclerosis, and Spinal Cord Injury
  • Any medical condition that would prevent the subject from being able to participate in the clinical outcome measures
  • Previous participating in a study involving the application of tsDCS
  • Pregnancy in women (as determined by pregnancy test in pre-menopausal women)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Stimulation
Five consecutive days of 20 minutes active stimulation with MyoRegulator® device
Device: MyoRegulator® device
Trans-spinal DCS paired with peripheral DCS
Other Names:
  • DoubleStim®
Sham Comparator: Sham Stimulation
Five consecutive days of 20 minutes sham stimulation with MyoRegulator® device
Device: MyoRegulator® device
Trans-spinal DCS paired with peripheral DCS
Other Names:
  • DoubleStim®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in wrist flexor spasticity following 5 days of treatment compared to baseline as measured by the Modified Ashworth Scale score
Time Frame: Up to 8 weeks post-treatment
The Modified Ashworth Scale is a validated clinical measurement for the evaluation of spasticity after stroke.
Up to 8 weeks post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Modified Ashworth Scale total upper limb score following 5 days of treatment as compared to baseline
Time Frame: Up to 8 weeks post-treatment
Here the Modified Ashworth Scale will be used to assess changes in spasticity in the entire upper limb.
Up to 8 weeks post-treatment
Change in Upper-Extremity Fugl-Meyer motor domain score following 5 days of treatment as compared to baseline
Time Frame: Up to 8 weeks post-treatment
The Upper-Extremity Fugl-Meyer scale is a validated clinical scale to evaluate motor function in post-stroke patients.
Up to 8 weeks post-treatment
Change in Modified Tardieu Scale total upper limb score following 5 days of treatment as compared to baseline
Time Frame: Up to 8 weeks post-treatment
The Modified Tardieu Scale is a validated clinical scale to evaluate spasticity in the upper limbs in stroke patients.
Up to 8 weeks post-treatment
Improvement in subject's self-assessment of their spasticity following 5 days of treatment as compared to baseline
Time Frame: Up to 8 weeks post-treatment
An 11-point Numerical Rating Scale will be used for this outcome measure.
Up to 8 weeks post-treatment
Improvement in spasticity as assessed by an investigator following 5 days of treatment as compared to baseline
Time Frame: Up to 8 weeks post-treatment
An 11-point Numerical Rating scale will be used for this outcome measure.
Up to 8 weeks post-treatment
Change in pain in the spastic limb following 5 days of treatment as compared to baseline
Time Frame: Up to 8 weeks post-treatment
A 10-point VAS scale (Wong-Baker Pain Scale) will be used for this outcome measure.
Up to 8 weeks post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PathMaker Neurosystems Inc.

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)
Spaulding Rehabilitation Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2022

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

January 28, 2021

First Submitted That Met QC Criteria

February 2, 2021

First Posted (Actual)

February 8, 2021

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMN-003
  • 1U44NS104138 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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