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

Primary Purpose

Muscle Spasticity, Stroke

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

MyoRegulator® device

About this trial

This is an interventional treatment trial for Muscle Spasticity focused on measuring stroke rehabilitation, spasticity, neuromodulation, trans-spinal direct current stimulation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Spaulding Rehabilitation HospitalRecruiting
Spaulding Rehabilitation HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active Stimulation

Sham Stimulation

Arm Description

Five consecutive days of 20 minutes active stimulation with MyoRegulator® device

Five consecutive days of 20 minutes sham stimulation with MyoRegulator® device

Outcomes

Primary Outcome Measures

Change in wrist flexor spasticity following 5 days of treatment compared to baseline as measured by the Modified Ashworth Scale score

The Modified Ashworth Scale is a validated clinical measurement for the evaluation of spasticity after stroke.

Secondary Outcome Measures

Change in Modified Ashworth Scale total upper limb score following 5 days of treatment as compared to baseline

Here the Modified Ashworth Scale will be used to assess changes in spasticity in the entire upper limb.

Change in Upper-Extremity Fugl-Meyer motor domain score following 5 days of treatment as compared to baseline

The Upper-Extremity Fugl-Meyer scale is a validated clinical scale to evaluate motor function in post-stroke patients.

Change in Modified Tardieu Scale total upper limb score following 5 days of treatment as compared to baseline

The Modified Tardieu Scale is a validated clinical scale to evaluate spasticity in the upper limbs in stroke patients.

Improvement in subject's self-assessment of their spasticity following 5 days of treatment as compared to baseline

An 11-point Numerical Rating Scale will be used for this outcome measure.

Improvement in spasticity as assessed by an investigator following 5 days of treatment as compared to baseline

An 11-point Numerical Rating scale will be used for this outcome measure.

Change in pain in the spastic limb following 5 days of treatment as compared to baseline

A 10-point VAS scale (Wong-Baker Pain Scale) will be used for this outcome measure.

Full Information

NCT ID

NCT04742257

First Posted

January 28, 2021

Last Updated

July 22, 2022

Sponsor

PathMaker Neurosystems Inc.

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04742257

Brief Title

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

Acronym

RECOVER

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 4, 2022 (Actual)

Primary Completion Date

October 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PathMaker Neurosystems Inc.

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

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.

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Muscle Spasticity, Stroke

Keywords

stroke rehabilitation, spasticity, neuromodulation, trans-spinal direct current stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active Stimulation

Arm Type

Experimental

Arm Description

Five consecutive days of 20 minutes active stimulation with MyoRegulator® device

Arm Title

Sham Stimulation

Arm Type

Sham Comparator

Arm Description

Five consecutive days of 20 minutes sham stimulation with MyoRegulator® device

Intervention Type

Device

Intervention Name(s)

MyoRegulator® device

Other Intervention Name(s)

DoubleStim®

Intervention Description

Trans-spinal DCS paired with peripheral DCS

Primary Outcome Measure Information:

Title

Change in wrist flexor spasticity following 5 days of treatment compared to baseline as measured by the Modified Ashworth Scale score

Description

The Modified Ashworth Scale is a validated clinical measurement for the evaluation of spasticity after stroke.

Time Frame

Up to 8 weeks post-treatment

Secondary Outcome Measure Information:

Title

Change in Modified Ashworth Scale total upper limb score following 5 days of treatment as compared to baseline

Description

Here the Modified Ashworth Scale will be used to assess changes in spasticity in the entire upper limb.

Time Frame

Up to 8 weeks post-treatment

Title

Change in Upper-Extremity Fugl-Meyer motor domain score following 5 days of treatment as compared to baseline

Description

The Upper-Extremity Fugl-Meyer scale is a validated clinical scale to evaluate motor function in post-stroke patients.

Time Frame

Up to 8 weeks post-treatment

Title

Change in Modified Tardieu Scale total upper limb score following 5 days of treatment as compared to baseline

Description

The Modified Tardieu Scale is a validated clinical scale to evaluate spasticity in the upper limbs in stroke patients.

Time Frame

Up to 8 weeks post-treatment

Title

Improvement in subject's self-assessment of their spasticity following 5 days of treatment as compared to baseline

Description

An 11-point Numerical Rating Scale will be used for this outcome measure.

Time Frame

Up to 8 weeks post-treatment

Title

Improvement in spasticity as assessed by an investigator following 5 days of treatment as compared to baseline

Description

An 11-point Numerical Rating scale will be used for this outcome measure.

Time Frame

Up to 8 weeks post-treatment

Title

Change in pain in the spastic limb following 5 days of treatment as compared to baseline

Description

A 10-point VAS scale (Wong-Baker Pain Scale) will be used for this outcome measure.

Time Frame

Up to 8 weeks post-treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sheila Hemeon-Heyer, J.D.

Phone

617-535-7696

sheyer@pmneuro.com

Facility Information:

Facility Name

Spaulding Rehabilitation Hospital

City

Cambridge

State/Province

Massachusetts

ZIP/Postal Code

02138

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andrea Christoforou, P.T., Ph.D., M.Sc., N.C.S.

Phone

617-952-6818

achristoforou@partners.org

Facility Name

Spaulding Rehabilitation Hospital

City

Charlestown

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Leon Morales-Quezada, M.D., Ph.D.

Phone

617-952-6162

jmorales-quezada@partners.org

12. IPD Sharing Statement

Citations:

PubMed Identifier

32232101

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.

Results Reference

background

Citation

Estudillo-Guerra MA, Mesia-Toledo I, Rogel N, Yaghoubi N, Ahmed Z, Black-Schaffer R, Morales-Quezada L.Trans-spinal direct current stimulation in spasticity: a literature mini-review. Front. Stroke. 2022 Jul 1;1:921450. doi: 10.3389/fstro.2022.921450.

Results Reference

background

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

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