This multicenter, randomized, double-blind, sham-controlled study is designed to evaluate the efficacy and safety of the iovera° system in subjects with upper extremity spasticity. A total of approximately 132 subjects will be enrolled; 88 subjects will receive treatment with the iovera° system and 44 subjects will receive sham treatment (sham iovera° system treatment).
The screening and treatment may occur on the same day or be separated by as much as 30 days. All screening procedures must be completed, and criteria must be met before a subject is randomly assigned in the study. After random allocation to treatment, the subject will be scheduled for treatment (Day 1). For all subjects, a Baseline (Day 1, pretreatment) Modified Ashworth Scale (MAS) score, Modified Tardieu Scale, and Goal Attainment Scale (GAS) score will be assessed and recorded before treatment on Day 1 (treatment day). On Day 1 (treatment day), subjects will be reassessed for eligibility and randomly assigned in a blinded fashion (2:1) to receive either the iovera° system treatment or sham treatment. The study device will be used per the iovera° system User Guide on subjects who are prepared with local anesthetic (lidocaine 1%) only. Local anesthetic will be injected subcutaneously into the treatment area. Ultrasound guidance will then be used to identify the specific target nerves to be studied. The targets of treatment are the medial and lateral pectoral nerves, and musculocutaneous nerve (motor branches to brachialis, and biceps brachii). A catheter will be used to guide the device needle. All subjects will have all target nerves treated. Nerve stimulation will also be employed as needed to assist in making an accurate determination regarding the location of the target nerves of interest. Up to two unblinded (1 primary and 1 backup) study staff (trained in the iovera° system treatment under ultrasound guidance) will be assigned per site to perform the study treatment procedures unless approved in advance in writing by the Sponsor on a case-by-case basis. The designated unblinded study staff must not participate in any other study-related assessments following treatment. Each subject will be followed for 13 weeks post-treatment. The follow-up visits will be conducted at Week 3/Day 21 (±3), Week 7/Day 49 (±3), and Week 13/Day 91 (±5). Subjects will be assessed for efficacy and safety outcomes parameters.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
132
subjects will receive ultrasound-guided iovera° system treatment
subjects will receive ultrasound-guided iovera° sham system treatment
Rancho Los Amigos National Rehabilitation Center
Downey, California, United States
Change from baseline in the Modified Ashworth Scale score for elbow measured (0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity)
Time frame: at week 13
Change from baseline in the Modified Ashworth Scale) score for shoulder (shoulder abduction) measured
Time frame: at week 13
Change from baseline in the Modified Tardieu Scales for elbow (0 to 5, where lower score represents no resistance, and higher score represents joint immobility; Increase in angle from baseline [R1, and R2] represents improvement)
Time frame: at week 13
Change from baseline in the Modified Tardieu Scales for shoulder (shoulder abduction)
Time frame: at week 13
Change from baseline in Goal Attainment Scale score evaluated by the blinded, trained, licensed medical staff (-2 to +2, where lower score represents less expected outcomes, and higher scores represent greater expected outcomes)
Time frame: at week 13
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