Cryoneurolysis for Spasticity
Trial Summary
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 data supports the effectiveness of the treatment Cryoneurolysis for spasticity?
Research shows that cryoneurolysis, a treatment that involves freezing nerves to reduce pain and muscle tightness, can improve movement and function in patients with spasticity. For example, a case study reported improved shoulder movement and daily activities in a child with cerebral palsy after the treatment. Additionally, cryotherapy, a similar cold treatment, has been shown to temporarily reduce spasticity in patients with brain and spinal cord injuries.12345
How does the treatment Cryoneurolysis differ from other treatments for spasticity?
Cryoneurolysis is unique because it involves freezing specific nerves to reduce spasticity, which is different from other treatments that may use medications or physical therapy to manage symptoms. This method targets the nerves directly, potentially offering a more localized and immediate effect.678910
What is the purpose of this trial?
Spasticity can make regular daily activities difficult or impossible. Cryoneurolysis is a new technique to treat spasticity that is currently being tested. For this technique, a needle is inserted alongside a nerve implicated in spasticity. The needle then freezes and causes the nerve to break down. The nerve breaking down seems to provide relief for spasticity. The investigators are interested in testing the long-term effects of cryoneurolysis on the function of the brain over six months after treatment. The investigators are testing the brain's function using transcranial magnetic stimulation (TMS) which involves a magnet activating specific parts of the brain that cause muscles to fire; magnetic resonance imaging (MRI) which uses to examine brain structure; functional near-infrared spectroscopy (fNIRS) to examine brain function. The investigators believe that there will be a change in these measures that are related to the long-lasting effects of cryoneurolysis. Cryoneurolysis is not a part of standard care after stroke but is approved in Canada for patients. It has been used extensively in the past for treating pain. TMS is a way of studying how the brain sends signals to muscles to make movement. During these sessions, a researcher will use a magnet to turn on specific neurons in the brain that will cause muscles to contract. The investigators can study the way eyes and muscles respond to better understand how the brain is sending information about moving the body to the muscles. FNIRS is a new way of studying how the brain works. During these sessions, a researcher will fit the participant with a cap that has several lights on it. The light travels through hair, scalp, and skull where it interacts with blood in the brain. By studying the changes in the colour of the blood in the brain, researchers can understand which parts of the brain are active during specific tasks. Magnetic Resonance Imaging (MRI) involves a powerful magnet that takes very detailed pictures of the brain. These images help the investigators to understand how a stroke is related to spasticity. Also, these images are helpful to make the stimulation with TMS more accurate. Study participation will require five visits to the Parkwood Institute Main Building and one visit to St. Joseph's Hospital. The entire study will take place over roughly six months. The investigators are recruiting 25 people with stroke who are eligible for cryoneurolysis to participate in the study.
Research Team
Sue Peters, PhD
Principal Investigator
Western University
Eligibility Criteria
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
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
Treatment Details
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