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

NCT04780191 | Completed

• 2 other identifiers: C16-1242017-A02060-53
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Spasticity; Stroke

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediately after last treatment session

Secondary Outcomes (6)

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

  Up to 3 months after last treatment session

• Change in walking performance from baseline to 3 months post-treatment

  Up to 3 months after last treatment session

• Change in functional performance from baseline to 3 months post-treatment

  Up to 3 months after last treatment session

• Change in muscle reaction from baseline to 3 months post-treatment

  Up to 3 months after last treatment session

• Change in subject's self-assessment of their spasticity from baseline to 3 months post-treatment

  Up to 3 months after last treatment session

Study Arms (2)

Active MyoRegulator® treatment

EXPERIMENTAL

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

Device: MyoRegulator®

Sham MyoRegulator® treatment

SHAM COMPARATOR

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

Device: MyoRegulator®

Interventions

MyoRegulator® DEVICE

Trans-spinal DC stimulation paired with peripheral DC stimulation

Active MyoRegulator® treatment; Sham MyoRegulator® treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead
• PathMaker Neurosystems Inc.: collaborator

Study Sites (1)

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

Paris, 75013, France

Location

Related Publications (1)

• 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 RESULT

MeSH Terms

Conditions

Muscle Spasticity; Stroke

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jean-Christophe Corvol, MD, PhD

  Institut du Cerveau et de la Moelle épinière

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: March 3, 2021
• Study Start: July 19, 2018
• Primary Completion: January 19, 2021
• Study Completion: January 19, 2021
• Last Updated: April 22, 2026

Record last verified: 2021-02

Locations

FR (1)