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

RecruitingNAAges 18 Years - anyAllSue Peters
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Cryoneurolysis
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Where

1 site
Parkwood Institute
London, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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