Spasticity as Sequela of Stroke study: Cryoneurolysis
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
- The study wants to see if cryoneurolysis changes brain function over six months after treatment.
- Who it's for
- Adults who have had a stroke and have spasticity that could be treated with cryoneurolysis.
- What's involved
- Participants will receive the cryoneurolysis procedure and attend several brain‑testing visits, including a magnet test (TMS), a brain scan (MRI), and a light‑based test (fNIRS).
- Time commitment
- The study lasts about six months and requires five visits at the Parkwood Institute and one visit at St. Joseph's Hospital.
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 is enrolling
- London, Ontario, Canada
Compensation & support
This study's listing mentions compensation or reimbursement.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
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, so 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, but 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?
This study is enrolling now at London, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.