NCT04780191

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France · Other Government
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Muscle Spasticity
• Stroke

Interventions

Type	Name	Description
DEVICE	MyoRegulator®	Trans-spinal DC stimulation paired with peripheral DC stimulation

Timeline

• Start date: 2018-07-19
• Primary completion: 2021-01-19
• Completion: 2021-01-19
• First posted: 2021-03-03
• Last updated: 2021-03-23

Locations

1 site across 1 country: France