Charlestown, Massachusetts 02114

  • Stroke

Purpose:

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 summary:

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.


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)


Study is Available At:


Original ID:

PMN-003


NCT ID:

NCT04742257


Secondary ID:

1U44NS104138


Study Acronym:

RECOVER


Brief Title:

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


Official Title:

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


Overall Status:

Not yet recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

85 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

PathMaker Neurosystems Inc.


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

76


Enrollment Type:

Anticipated


Overall Contact Information

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

Study Dates

Start Date:May 1, 2021
Completion Date:November 15, 2022
Completion Type:Anticipated
Primary Completion Date:October 1, 2022
Primary Completion Type:Anticipated
Verification Date:February 2021
Last Changed Date:February 2, 2021
First Received Date:January 28, 2021

Study Outcomes

Outcome Type:Primary Outcome
Measure:Change in wrist spasticity from baseline to between Visit 7 and Visit 9
Time Frame:2 to 6 weeks post-treatment
Safety Issues:False
Description:Change in spasticity as measured by the Modified Ashworth Scale (MAS) score between 2 and 6 weeks after 5 treatments as compared to baseline.
Outcome Type:Secondary Outcome
Measure:Change in Modified Ashworth Scale total upper limb score from baseline to Visit 11
Time Frame:Up to 3 months post-treatment
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Change in Upper-Extremity Fugl-Meyer motor domain score from baseline to Visit 11
Time Frame:Up to 3 months post-treatment
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Change in Modified Tardieu Scale total upper limb score from baseline to Visit 11
Time Frame:Up to 3 months post-treatment
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Improvement in subject's self-assessment of their spasticity from baseline to Visit 11
Time Frame:Up to 3 months post-treatment
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Change in pain in the spastic limb from baseline to Visit 11
Time Frame:Up to 3 months post-treatment
Safety Issues:False
Description: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

Study Interventions

Intervention Type:Device
Name:MyoRegulator® device
Description:Trans-spinal DCS paired with peripheral DCS
Arm Name:Active Stimulation
Other Name:DoubleStim®

Study Arms

Study Arm Type:Sham Comparator
Arm Name:Sham Stimulation
Description:Five consecutive days of 20 minutes sham stimulation with MyoRegulator® device
Study Arm Type:Experimental
Arm Name:Active Stimulation
Description:Five consecutive days of 20 minutes active stimulation with MyoRegulator® device

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:PathMaker Neurosystems Inc.
Agency Class:Other
Agency Type:Collaborator
Agency Name:Spaulding Rehabilitation Hospital

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Paget-Blanc A, Chang JL, Saul M, Lin R, Ahmed Z, Volpe BT. Non-invasive treatment of patients with upper extremity spasticity following stroke using paired trans-spinal and peripheral direct current stimulation. Bioelectron Med. 2019 Jul 23;5:11. doi: 10.1186/s42234-019-0028-9. eCollection 2019.
PMID:32232101

Data Source: ClinicalTrials.gov

Date Processed: August 01, 2021

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