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Investigation of Treatment Using the MyoRegulator® Device in Patients With Spasticity in the Lower Limb Due to Stroke (SPAST)

Primary Purpose

Muscle Spasticity, Stroke

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

MyoRegulator®

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:

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.

Exclusion Criteria:

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
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

Sites / Locations

Centre d'investigation clinique, Institut du Cerveau et de la Moelle

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active MyoRegulator® treatment

Sham MyoRegulator® treatment

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 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.

Secondary Outcome Measures

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

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

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

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

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

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

Full Information

NCT ID

NCT04780191

First Posted

July 13, 2018

Last Updated

March 19, 2021

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Collaborators

PathMaker Neurosystems Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04780191

Brief Title

Investigation of Treatment Using the MyoRegulator® Device in Patients With Spasticity in the Lower Limb Due to Stroke

Acronym

SPAST

Official Title

Investigation of Treatment Using the MyoRegulator® Device in Patients With Spasticity in the Lower Limb Due to Stroke

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

July 19, 2018 (Actual)

Primary Completion Date

January 19, 2021 (Actual)

Study Completion Date

January 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Collaborators

PathMaker Neurosystems Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

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.

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

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active MyoRegulator® treatment

Arm Type

Experimental

Arm Description

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

Arm Title

Sham MyoRegulator® treatment

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

MyoRegulator®

Intervention Description

Trans-spinal DC stimulation paired with peripheral DC stimulation

Primary Outcome Measure Information:

Title

Change in spasticity from baseline to after the last treatment session

Description

Change in spasticity as measured by the Modified Tardieu Scale (MTS) after 5 treatments as compared to baseline.

Time Frame

Immediately after last treatment session

Secondary Outcome Measure Information:

Title

Change in gait parameters from baseline to 3 months post-treatment

Description

Change in walking up to 3 months after 5 treatments as compared to baseline as measured using a gait analysis system

Time Frame