RecruitingNot Applicable

Cryoneurolysis for Spasticity Treatment: Long-term Clinical Outcomes and Mechanisms in the Central Nervous System

Canada25 participantsStarted 2025-08-01

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 in 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, * if on anti-spastic medication, maintaining anti-spastic medications on a stable schedule over the course of the follow up period, and * they can understand and follow instructions in English. Exclusion Criteria: * have contraindications to TMS (i.e., history of seizure, pregnancy) or 3T MRI (i.e., certain metallic implants), * are unable to provide informed consent (i.e., severe cognitive impairment), * receive any toxin injections for spasticity (Botulinum-A Toxin or equivalent) within 3 months of initial baseline assessments or at any time over the course of the follow-up period. * Have previously undergone any nerve-specific interventions (phenol neurolysis, radio-frequency ablation, or cryoneurolysis) for spasticity on a nerve that will be targeted for this study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

TMS

Timeframe: 6-months compared to baseline

fNIRS

Timeframe: 6-months compared to baseline

Trial details

NCT IDNCT06958289

SponsorSue Peters

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-01

Contact for this trial

Sue Peters, PhD

1-519-646-6100 speter49@uwo.ca

View on ClinicalTrials.gov More Spasticity as Sequela of Stroke trials