Status:
COMPLETED
Investigation of Treatment Using the MyoRegulator® Device in Patients With Spasticity in the Lower Limb Due to Stroke
Lead Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Collaborating Sponsors:
PathMaker Neurosystems Inc.
Conditions:
Muscle Spasticity
Stroke
Eligibility:
All Genders
18-85 years
Phase:
NA
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® devi...
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 obser...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 19 2021
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04780191
Start Date
July 19 2018
End Date
January 19 2021
Last Update
March 23 2021
Active Locations (1)
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1
Centre d'investigation clinique, Institut du Cerveau et de la Moelle
Paris, France, 75013