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

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ClinicalTrials.gov Identifier: NCT04742257
Recruitment Status : Not yet recruiting
First Posted : February 8, 2021
Last Update Posted : February 8, 2021
Sponsor:
Collaborators:
Spaulding Rehabilitation Hospital
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
PathMaker Neurosystems Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Muscle Spasticity Stroke Device: MyoRegulator® device Not Applicable

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 between 2 and 6 weeks post-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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Multi-Center, Randomized, Sham-Controlled Study Evaluating MyoRegulator® Treatment in Post-Stroke Upper Limb Spasticity
Estimated Study Start Date : May 1, 2021
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : November 15, 2022

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 Name: 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 Name: DoubleStim®




Primary Outcome Measures :
  1. Change in wrist spasticity from baseline to between Visit 7 and Visit 9 [ Time Frame: 2 to 6 weeks post-treatment ]
    Change in spasticity as measured by the Modified Ashworth Scale (MAS) score between 2 and 6 weeks after 5 treatments as compared to baseline.


Secondary Outcome Measures :
  1. Change in Modified Ashworth Scale total upper limb score from baseline to Visit 11 [ Time Frame: Up to 3 months post-treatment ]
    Change in upper-limb spasticity as measured by the total Modified Ashworth Scale (MAS) score up to 3 months after 5 treatments as compared to baseline

  2. Change in Upper-Extremity Fugl-Meyer motor domain score from baseline to Visit 11 [ Time Frame: Up to 3 months post-treatment ]
    Change in motor function as measured by the total Upper-Extremity Fugl-Meyer (UE-FM) motor domain score up to 3 months after 5 treatments as compared to baseline

  3. Change in Modified Tardieu Scale total upper limb score from baseline to Visit 11 [ Time Frame: Up to 3 months post-treatment ]
    Change in upper-limb spasticity as measured by the total Modified Tardieu Scale (MTS) score up to 3 months after 5 treatments as compared to baseline

  4. Improvement in subject's self-assessment of their spasticity from baseline to Visit 11 [ Time Frame: Up to 3 months post-treatment ]
    Improvement in subject's self-assessment of their spasticity up to 3 months after 5 treatments as compared to baseline as measured using an 7-point Numerical Rating Scale

  5. Change in pain in the spastic limb from baseline to Visit 11 [ Time Frame: Up to 3 months post-treatment ]
    Change in pain in the spastic limb using a 10-point VAS scale (Wong-Baker Pain Scale) up to 3 months after 5 treatments as compared to baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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, elbow, or shoulder joints
  • Willing to forgo botulinum toxin, phenol or alcohol injections, intrathecal baclofen, digitalis, and morphine for the subject's duration in the study
  • Willing to maintain current rehabilitation regimen for the subject's duration in the study
  • Willing to maintain current oral spasticity medication regimen 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) within 12 weeks of study enrollment
  • Prior phenol or alcohol injections 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
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04742257


Contacts
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Contact: Sheila Hemeon-Heyer, J.D. 617-535-7696 sheyer@pmneuro.com

Locations
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United States, Massachusetts
Spaulding Rehabilitation Hospital
Charlestown, Massachusetts, United States, 02114
Contact: Leon Morales-Quezada, M.D., Ph.D.    617-952-6162    jmorales-quezada@partners.org   
Sponsors and Collaborators
PathMaker Neurosystems Inc.
Spaulding Rehabilitation Hospital
National Institute of Neurological Disorders and Stroke (NINDS)
Publications:
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Responsible Party: PathMaker Neurosystems Inc.
ClinicalTrials.gov Identifier: NCT04742257    
Other Study ID Numbers: PMN-003
1U44NS104138 ( U.S. NIH Grant/Contract )
First Posted: February 8, 2021    Key Record Dates
Last Update Posted: February 8, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by PathMaker Neurosystems Inc.:
stroke rehabilitation
spasticity
neuromodulation
trans-spinal direct current stimulation
Additional relevant MeSH terms:
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Muscle Spasticity
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations