Cryoneurolysis for Spasticity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new technique called cryoneurolysis to assist individuals experiencing muscle stiffness (spasticity) after a stroke. Cryoneurolysis uses a freezing technique to break down specific nerves, potentially relieving muscle stiffness and improving movement. Researchers aim to assess how this treatment affects brain function over six months. They employ methods like magnetic pulses and brain imaging to study these changes. Ideal participants have had a stroke, can understand English, and have experienced relief from a test nerve block. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatments for stroke-related spasticity.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any antispastic medications during the follow-up period of the trial.
What prior data suggests that this technique is safe for treating spasticity?
Research has shown that cryoneurolysis has been safely used for many years, particularly for pain management. Studies indicate it is a promising treatment for muscle stiffness (spasticity) with generally manageable side effects. Most people do not experience pain or numbness for more than three months after treatment, suggesting it is usually well-tolerated. Cryoneurolysis is approved for use in Canada, indicating a good safety record. However, it is important to note that while not yet a standard treatment for spasticity, research continues to explore its long-term effects.12345
Why are researchers excited about this trial?
Unlike the standard treatments for spasticity, which often include medications like baclofen or physical therapies, cryoneurolysis offers a novel approach by applying extreme cold directly to targeted nerves. This technique induces a process called Wallerian degeneration, where the nerve's axon is destroyed, stopping it from sending signals, but allows the nerve to regenerate naturally over time. Researchers are excited about cryoneurolysis because it targets the nerves directly and may provide longer-lasting relief without the need for continuous medication, potentially reducing side effects associated with systemic drug treatments.
What evidence suggests that cryoneurolysis is effective for treating spasticity?
Research has shown that cryoneurolysis, the treatment under study in this trial, can help reduce spasticity, a condition where muscles become too tight and hard to move. In several studies, patients who received cryoneurolysis experienced significant benefits, such as easier limb movement and reduced pain. For instance, one study found that 13 out of 16 patients reported less muscle tightness for at least six months. Another study demonstrated that cryoneurolysis provided lasting relief from spasticity and improved limb movement for up to a year. These findings suggest that cryoneurolysis may help people with spasticity move more freely and with less discomfort.26789
Who Is on the Research Team?
Sue Peters, PhD
Principal Investigator
Western University
Are You a Good Fit for This Trial?
This trial is for individuals with spasticity, a condition that can interfere with daily activities. Participants should have had a stroke and be eligible for cryoneurolysis treatment in Canada. The study involves six visits over six months to specific hospitals.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive cryoneurolysis treatment, involving the application of extreme cold to targeted nerves under ultrasound guidance
Follow-up
Participants are monitored for changes in spasticity severity and brain function using TMS, MRI, and fNIRS
Long-term Monitoring
Participants' health-related quality of life, range of motion, and grip strength are assessed over time
What Are the Treatments Tested in This Trial?
Interventions
- Cryoneurolysis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sue Peters
Lead Sponsor
Pacira Pharmaceuticals, Inc
Industry Sponsor
Dr. Jonathan Slonin
Pacira Pharmaceuticals, Inc
Chief Medical Officer since 2020
BSc in Biomedical Engineering and MD from University of Miami, MBA from George Washington University
Frank D. Lee
Pacira Pharmaceuticals, Inc
Chief Executive Officer since 2024
BSc in Chemical Engineering from Vanderbilt University, MBA from Wharton Graduate School of Business