Cryoneurolysis Treatment for Stroke-Related Spasticity Long-Term Effects and Brain Mechanisms Over Six Months

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.

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