iovera° system
Efficacy and Safety of iovera° system for Patients With Upper Extremity Spasticity
Summary1
Condition: Upper extremity spasticity
Treatment: iovera° system, sham treatment
Male & Female
Age Range: 18–100 years
18 Locations
Phase 3
What is this study about?
- This study is exploring whether the iovera° system, a device that uses focused cold therapy, can safely and effectively reduce muscle stiffness (spasticity) in the upper arm for people living with upper extremity spasticity. Spasticity can cause tight, rigid muscles that limit movement and make daily activities challenging. Researchers aim to learn if using the iovera° system to temporarily block nerve activity can help improve muscle tone and movement compared with a sham (inactive) procedure1-3
What treatment is being studied?
- The treatment being studied is the iovera° system, a medical device that delivers focused cold therapy to targeted nerves1
- How it works: The iovera° system briefly freezes small areas of nerve tissue to interrupt signals that cause muscle overactivity. This effect is temporary and designed to reduce stiffness and improve movement1
- How it’s given: The treatment is performed using ultrasound guidance to identify the target nerves in the upper arm1
- The study compares the iovera° treatment with a sham (inactive) procedure that mimics the treatment but does not deliver cold therapy1,2
What will happen during the study?
- About 132 participants with upper extremity spasticity will be randomly assigned in a 2:1 ratio to receive either the iovera° treatment or a sham procedure. Before treatment, participants will complete several assessments to measure muscle stiffness, movement, and treatment goals. On the treatment day, a small amount of local anesthetic will be applied, and the iovera° system will be used to target specific nerves in the upper arm that control muscle tone. After treatment, participants will return for follow-up visits to assess safety and improvements in muscle tone and arm movement. The total study duration for each participant is about 13 weeks1
How can I learn more?
If you’d like to learn more about this study or find out whether you may be eligible to participate, talk to your healthcare provider, reach out to the study team at your local research center, contact christine.brozyniak@pacira.com, or visit this site to learn more.
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