Muscle SpasticityRECOVERNCT04742257
Study Evaluating MyoRegulator® Treatment in Post-Stroke Upper Limb Spasticity
A study testing MyoRegulator® device in people with Muscle Spasticity and Stroke, run by PathMaker Neurosystems Inc. at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Muscle Spasticity, Stroke
- What is being tested?
- MyoRegulator® device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Mar 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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)
Who cannot join
- 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
Show all 17Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Spaulding Rehabilitation Hospital
Cambridge, Massachusetts, 02138
Spaulding Rehabilitation Hospital
Charlestown, Massachusetts, 02114
About this study
Official title: 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.
Read the 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.
- Conditions
- Muscle Spasticity, Stroke
- Being tested
- MyoRegulator® device
- Keywords
- stroke rehabilitation, spasticity, neuromodulation, trans-spinal direct current stimulation
- Medical subject headings
- Muscle Spasticity, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyoRegulator® deviceDevice
Also called DoubleStim®
Trans-spinal DCS paired with peripheral DCS
| Study group | Role | What they receive |
|---|---|---|
| Active Stimulation | Experimental | Five consecutive days of 20 minutes active stimulation with MyoRegulator® device Receives: Device: MyoRegulator® device |
| Sham Stimulation | Sham comparator | Five consecutive days of 20 minutes sham stimulation with MyoRegulator® device Receives: Device: MyoRegulator® device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 8 weeks post-treatment
Secondary outcomes (6)
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.
Measured: Up to 8 weeks post-treatment
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.
Measured: Up to 8 weeks post-treatment
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.
Measured: Up to 8 weeks post-treatment
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.
Measured: Up to 8 weeks post-treatment
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.
Measured: Up to 8 weeks post-treatment
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.
Measured: Up to 8 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start4 Mar 2022
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Muscle SpasticityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- PathMaker Neurosystems Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Spaulding Rehabilitation Hospital, National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04742257
- Sponsor's protocol ID
- PMN-003
- Other IDs
- 1U44NS104138
- Acronym
- RECOVER
- Status last verified
- Nov 2023
- First submitted
- 28 Jan 2021
- Last updated
- 15 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 32232101Estudillo-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. eCollection 2022.
PubMed 41541586
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center, Randomized, Sham-Controlled Study Evaluating MyoRegulator® Treatment in Post-Stroke Upper Limb Spasticity
- ClinicalTrials.gov ID
- NCT04742257
- Acronym / sponsor ID
- RECOVER / PMN-003
- Conditions
- Muscle Spasticity, Stroke
- Keywords
- stroke rehabilitation, spasticity, neuromodulation, trans-spinal direct current stimulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 28 participants (actual)
- Lead sponsor
- PathMaker Neurosystems Inc.Industry (pharma, biotech, devices)
- Collaborators
- Spaulding Rehabilitation Hospital, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 4 Mar 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 8 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Stimulation | Experimental | Device: MyoRegulator® deviceFive consecutive days of 20 minutes active stimulation with MyoRegulator® device |
| Sham Stimulation | Sham comparator | Device: MyoRegulator® deviceFive consecutive days of 20 minutes sham stimulation with MyoRegulator® device |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 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)
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyoRegulator® deviceAlso: DoubleStim®Trans-spinal DCS paired with peripheral DCS | Device | Active Stimulation, Sham Stimulation |
Primary outcome
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.
6 secondary outcomes
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
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
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
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
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
Change in pain in the spastic limb following 5 days of treatment as compared to baseline
Time frame: Up to 8 weeks post-treatment
Results and safety
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Background: PubMed 32232101Paget-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.
- Background: PubMed 41541586Estudillo-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. eCollection 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyoRegulator® device in people with Muscle Spasticity and Stroke, run by PathMaker Neurosystems Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04742257, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.