Cryoneurolysis to reduce post-stroke spasticity and measure brain changes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Cryoneurolysis delivers a freezing needle alongside a targeted peripheral nerve to produce localized nerve breakdown and reduce focal spasticity. The study enrolls people with post-stroke spasticity who show benefit from a diagnostic nerve block and have at least flicker movement in the affected upper limb. Investigators will record brain and motor system measures using transcranial magnetic stimulation (TMS), structural MRI, and functional near-infrared spectroscopy (fNIRS) before and over six months after treatment. The protocol excludes people with contraindications to TMS or 3T MRI, recent botulinum toxin injections, or inability to consent.

Why it matters

Who can join: the full rules

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.

Where it's running

• Parkwood Institute
  London, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Sue Peters, PhD — Western University
• Study coordinator: Sue Peters, PhD
• Email: speter49@uwo.ca
• Phone: 1-519-646-6100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.