Status:
NOT_YET_RECRUITING
Cryoneurolysis for Spasticity Treatment: Long-term Clinical Outcomes and Mechanisms in the Central Nervous System
Lead Sponsor:
Sue Peters
Collaborating Sponsors:
Pacira Pharmaceuticals, Inc
Conditions:
Spasticity as Sequela of Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 alo...
Detailed Description
Spasticity is the result of an overactive stretch reflex after an upper motor neuron injury that results in affected muscles being constantly, involuntarily contracted.1 A failure to treat spasticity ...
Eligibility Criteria
Inclusion
- are a patient at Parkwood Institute
- 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, and
- they can understand and follow instructions in English.
Exclusion
- 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 antispastic medication (oral, intrathecal, or otherwise) over the course of the follow-up period
- 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.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06958289
Start Date
May 1 2025
End Date
May 1 2028
Last Update
May 6 2025
Active Locations (1)
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1
Parkwood Institute
London, Ontario, Canada, N6C 0A7