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New treatment option for Spasticity as Sequela of Stroke
Official title Cryoneurolysis for Spasticity Treatment: Long-term Clinical Outcomes and Mechanisms in the Central Nervous System
ClinicalTrials.gov ID: NCT06958289
What this study is testing
- What it's testing
- Spasticity can make regular daily activities difficult or impossible. Cryoneurolysis is a new technique to treat spasticity that is currently being tested.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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,
You likely can't join if
- 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...
- Have previously undergone any nerve-specific interventions (phenol neurolysis, radio-frequency ablation, or cryoneurolysis) for spasticity on a nerve...
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- London, Ontario, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.