Actively Recruiting
Cryoneurolysis for Spasticity Treatment: Quantifying Long-term Clinical Outcomes and Exploring Mechanisms Within the Central Nervous System
Led by Sue Peters · Updated on 2026-04-21
25
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
S
Sue Peters
Lead Sponsor
P
Pacira Pharmaceuticals, Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the long-term effects of cryoneurolysis, a new treatment for spasticity following stroke, on brain function over six months. Spasticity causes muscles to be constantly contracted, making daily activities difficult. Cryoneurolysis uses extreme cold applied near nerves to break down nerve fibers, which may relieve spasticity. Researchers will use brain imaging and stimulation techniques such as transcranial magnetic stimulation (TMS), magnetic resonance imaging (MRI), and functional near-infrared spectroscopy (fNIRS) to study brain changes related to this treatment. Participants will receive cryoneurolysis applied under ultrasound guidance to nerves involved in spasticity. This procedure causes nerve axons to break down but leaves surrounding nerve layers intact, allowing nerve regrowth along the original path. The study involves five visits to one facility and one visit to another over roughly six months. Researchers will monitor brain function and structure at baseline and several time points after treatment to understand how cryoneurolysis affects the nervous system. During the study, participants will undergo assessments including TMS to stimulate brain regions and measure muscle responses, MRI scans to examine brain structure, and fNIRS to monitor brain activity via light signals through the scalp. These evaluations will occur at baseline, immediately after treatment, and at 1, 3, and 6 months. The study will measure changes in brain function and connectivity related to spasticity relief. Overall participation lasts about six months, with safety and treatment effects closely tracked throughout.
CONDITIONS
Brief Title
Cryoneurolysis for Spasticity Treatment: Long-term Clinical Outcomes and Mechanisms in the Central Nervous System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have increased range of motion or reduced spasticity with diagnostic nerve block
- Have no undesired loss of function with a diagnostic nerve block
- Score 2 or higher on the Modified Ashworth scale
- Have at least flickers of movement in the upper extremity
- Have not received botulinum-A neurotoxin within the past 3 months
- Maintain stable anti-spastic medication schedule if currently taking these medications during follow-up
- Understand and follow instructions in English
You will not qualify if you...
- Have contraindications to transcranial magnetic stimulation (such as history of seizure or pregnancy) or 3T MRI (such as certain metallic implants)
- Unable to provide informed consent due to severe cognitive impairment
- Received any toxin injections for spasticity within 3 months before baseline or during follow-up
- Have previously had nerve-specific interventions (phenol neurolysis, radio-frequency ablation, or cryoneurolysis) on a nerve targeted in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment visit
Participants receive cryoneurolysis, where extreme cold is applied directly to or near targeted nerves under ultrasound guidance to prevent nerve signal propagation.
1 visit (in-person)
Duration - 6 months
Participants are monitored for changes in spasticity and neural activity using neuroimaging and stimulation techniques.
Visits immediately post-treatment, 1 month, 3 months, and 6 months post-treatment
Trial Site Locations
Total: 1 location
1
Parkwood Institute
London, Ontario, Canada, N6C 0A7
Actively Recruiting
Research Team
S
Sue Peters, PhD
N
Nagina Naz, BSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here