Muscle SpasticitySPASTNCT04780191
Investigation of Treatment Using the MyoRegulator® Device in Patients With Spasticity in the Lower Limb Due to Stroke
A study testing MyoRegulator® in people with Muscle Spasticity and Stroke, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
This is a single center, randomized, double-blind (patient and evaluator), sham-controlled study. The main objectives of this study are to evaluate the performance and safety of the MyoRegulator® device in active versus sham treated stroke patients with lower-limb spasticity after 5 consecutive days of treatment. 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®
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jul 2018to 19 Jan 2021
- 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
- Stroke, with cortical and/or subcortical lesions, of at least 6-months duration at study inclusion
- Spasticity in the lower extremity plantarflexors (gastrocnemius, soleus muscles) due to stroke with a baseline score of 1-4 as assessed by the Tardieu scale
- Minimum 1-month duration of spasticity as confirmed by medical history
- Modified Rankin score < 4
- Cognitive functions sufficient to understand the experiments and follow instructions and ability to provide informed consent in accordance with ICH and GCP
- Affiliated with the French social security scheme, universal medical coverages (CMU), or an equivalent scheme.
Who cannot join
- Enrollment in another biomedical research study at the time of the MyoRegulator study.
- Fixed contractures or profound muscle atrophy in the spastic limb
- Ongoing use of digitalis, morphine, intrathecal pump
- Plantar orthosis or history of orthopedic surgery that can interfere with gait analysis
- Botulinum toxin treatment within 12 weeks of study enrollment
- Prior phenol or alcohol injections within 6 months of study enrollment
Show all 18Show fewer
- Change in the antispastic treatment (baclofen, clonidine, benzodiazepine, dantrolene, gabapentine, tizanidin) in the 2 months prior to visit 1.
- Allergy to latex
- 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, cancerous lesions, etc.)
- Lack of sensory perception at the stimulation sites
- Presence of an electrically, magnetically or mechanically activated implant (including cardiac pacemaker, epidural stimulation electrodes, etc.), an intravascular clip or any other electrically sensitive support system
- Metal in or on the body in the direct path of the stimulation current (jewelry must be removed during stimulation)
- Past history of seizures or unexplained spells of loss of consciousness during the previous 36 months
- Prior trans-spinal direct current stimulation for any reason or prior trans-cranial direct current stimulation in the past 12 months
- Any medical condition that would prevent the subject from being able to participate in the clinical outcome measures
- Pregnancy in women (as determined by a urine pregnancy test in pre-menopausal women), or lactating women or women planning pregnancy during the course of the study
- Patient under guardianship or curatorship, or under judicial supervision
Trial locations and contacts
1 site in 1 country.
France1 site
Centre d'investigation clinique, Institut du Cerveau et de la Moelle
Paris, 75013
About this study
This is a single center, randomized, double-blind (patient and evaluator), sham-controlled study. The main objectives of this study are to evaluate the performance and safety of the MyoRegulator® device in active versus sham treated stroke patients with lower-limb spasticity after 5 consecutive days of treatment.
Read the detailed description
Spasticity prevalence after stroke is highly variable, ranging from 17% to 43% three months post-stroke. In the lower limbs, adduction and extension of the knee with equinovarus foot is the most observed pattern. Spasticity can lead to pain, ankylosis, and tendon retraction which may limit the potential success of rehabilitation. Spasticity can also affect quality-of-life and can be highly detrimental to daily activities such as walking.
An initial clinical trial of safety and feasibility suggested 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-invasive neuromodulation device using multi-site direct current stimulation for the treatment of spasticity. The main objectives of this study are to evaluate the performance and safety of the MyoRegulator® device in active versus sham treated patients during and after 5 consecutive days of treatment sessions. Patients can take part in an optional 3-month follow-up.
The primary performance endpoint is defined as the reduction in ankle joint spasticity. The study will be considered to have a successful outcome if the actively treated subjects demonstrate a statistically greater reduction in spasticity, as measured by the Tardieu Scale, as compared to the sham treated subjects after five treatment sessions.
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.
- Conditions
- Muscle Spasticity, Stroke
- Being tested
- MyoRegulator®
- 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®Device
Trans-spinal DC stimulation paired with peripheral DC stimulation
| Study group | Role | What they receive |
|---|---|---|
| Active MyoRegulator® treatment | Experimental | Five consecutive days of 20 minutes active stimulation with MyoRegulator® device Receives: Device: MyoRegulator® |
| Sham MyoRegulator® treatment | Sham comparator | Five consecutive days of 20 minutes sham stimulation with MyoRegulator® device Receives: Device: MyoRegulator® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in spasticity from baseline to after the last treatment session
Change in spasticity as measured by the Modified Tardieu Scale (MTS) after 5 treatments as compared to baseline.
Measured: Immediately after last treatment session
Secondary outcomes (6)
Change in gait parameters from baseline to 3 months post-treatment
Change in walking up to 3 months after 5 treatments as compared to baseline as measured using a gait analysis system
Measured: Up to 3 months after last treatment session
Change in walking performance from baseline to 3 months post-treatment
Change in walking performance up to 3 months after 5 treatments as compared to baseline as measured using the 10-meter walk test
Measured: Up to 3 months after last treatment session
Change in functional performance from baseline to 3 months post-treatment
Change in functional performance up to 3 months after 5 treatments as compared to baseline as measured using the Fugl Meyer assessment
Measured: Up to 3 months after last treatment session
Change in muscle reaction from baseline to 3 months post-treatment
Change in muscle reaction up to 3 months after 5 treatments as compared to baseline as measured using the H-reflex
Measured: Up to 3 months after last treatment session
Change in subject's self-assessment of their spasticity from baseline to 3 months post-treatment
Change in subject's self-assessment of their spasticity up to 3 months after 5 treatments as compared to baseline as measured using an 11-point Numerical Rating Scale
Measured: Up to 3 months after last treatment session
Change in subject's quality of life from baseline to 3 months post-treatment
Change in subject's self-assessment of quality of life up to 3 months after 5 treatments as compared to baseline as measured using the SF-36 scale
Measured: Up to 3 months after last treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start19 Jul 2018
- Primary completion19 Jan 2021
- Study completion19 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle SpasticityStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- 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
- 44 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- PathMaker Neurosystems Inc.
- Responsible party
- Sponsor
- Investigators
- Jean-Christophe Corvol, MD, PhD, Principal investigator, Paris Brain Institute (ICM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780191
- Sponsor's protocol ID
- C16-124
- Other IDs
- 2017-A02060-53
- Acronym
- SPAST
- Status last verified
- Feb 2021
- First submitted
- 13 Jul 2018
- Last updated
- 22 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 32232101
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Treatment Using the MyoRegulator® Device in Patients With Spasticity in the Lower Limb Due to Stroke
- ClinicalTrials.gov ID
- NCT04780191
- Acronym / sponsor ID
- SPAST / C16-124
- Conditions
- Muscle Spasticity, Stroke
- Keywords
- stroke rehabilitation, spasticity, neuromodulation, trans-spinal direct current stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- PathMaker Neurosystems Inc.
- Study start
- 19 Jul 2018 (actual)
- Primary completion
- 19 Jan 2021 (actual)
- Study completion
- 19 Jan 2021 (actual)
- First posted
- 3 Mar 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 single center, randomized, double-blind (patient and evaluator), sham-controlled study. The main objectives of this study are to evaluate the performance and safety of the MyoRegulator® device in active versus sham treated stroke patients with lower-limb spasticity after 5 consecutive days of treatment.
Detailed description
Spasticity prevalence after stroke is highly variable, ranging from 17% to 43% three months post-stroke. In the lower limbs, adduction and extension of the knee with equinovarus foot is the most observed pattern. Spasticity can lead to pain, ankylosis, and tendon retraction which may limit the potential success of rehabilitation. Spasticity can also affect quality-of-life and can be highly detrimental to daily activities such as walking.
An initial clinical trial of safety and feasibility suggested 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-invasive neuromodulation device using multi-site direct current stimulation for the treatment of spasticity. The main objectives of this study are to evaluate the performance and safety of the MyoRegulator® device in active versus sham treated patients during and after 5 consecutive days of treatment sessions. Patients can take part in an optional 3-month follow-up.
The primary performance endpoint is defined as the reduction in ankle joint spasticity. The study will be considered to have a successful outcome if the actively treated subjects demonstrate a statistically greater reduction in spasticity, as measured by the Tardieu Scale, as compared to the sham treated subjects after five treatment sessions.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active MyoRegulator® treatment | Experimental | Device: MyoRegulator®Five consecutive days of 20 minutes active stimulation with MyoRegulator® device |
| Sham MyoRegulator® treatment | Sham comparator | Device: MyoRegulator®Five 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 (6 listed)
- Stroke, with cortical and/or subcortical lesions, of at least 6-months duration at study inclusion
- Spasticity in the lower extremity plantarflexors (gastrocnemius, soleus muscles) due to stroke with a baseline score of 1-4 as assessed by the Tardieu scale
- Minimum 1-month duration of spasticity as confirmed by medical history
- Modified Rankin score < 4
- Cognitive functions sufficient to understand the experiments and follow instructions and ability to provide informed consent in accordance with ICH and GCP
Key exclusion criteria (18 listed)
- Enrollment in another biomedical research study at the time of the MyoRegulator study.
- Fixed contractures or profound muscle atrophy in the spastic limb
- Ongoing use of digitalis, morphine, intrathecal pump
- Plantar orthosis or history of orthopedic surgery that can interfere with gait analysis
- Botulinum toxin treatment within 12 weeks 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®Trans-spinal DC stimulation paired with peripheral DC stimulation | Device | Active MyoRegulator® treatment, Sham MyoRegulator® treatment |
Primary outcome
Change in spasticity from baseline to after the last treatment session
Time frame: Immediately after last treatment session
Change in spasticity as measured by the Modified Tardieu Scale (MTS) after 5 treatments as compared to baseline.
6 secondary outcomes
Change in gait parameters from baseline to 3 months post-treatment
Time frame: Up to 3 months after last treatment session
Change in walking performance from baseline to 3 months post-treatment
Time frame: Up to 3 months after last treatment session
Change in functional performance from baseline to 3 months post-treatment
Time frame: Up to 3 months after last treatment session
Change in muscle reaction from baseline to 3 months post-treatment
Time frame: Up to 3 months after last treatment session
Change in subject's self-assessment of their spasticity from baseline to 3 months post-treatment
Time frame: Up to 3 months after last treatment session
Change in subject's quality of life from baseline to 3 months post-treatment
Time frame: Up to 3 months after last treatment session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Results publication: 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.
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Spasticity, Stroke
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.
Jean-Christophe Corvol, MD, PhD principal investigator
Paris Brain Institute (ICM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyoRegulator® in people with Muscle Spasticity and Stroke, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
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 6 inclusion and 18 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: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 spasticity from baseline to after the last treatment session (time frame: Immediately after last treatment session). 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 NCT04780191, which also lists 1 linked publication.
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 22 Apr 2026.