Collagenase Injection for Spasticity Management
This study is investigating if XIAFLEX Collagenase injections can help manage spasticity (muscle stiffness) in people who have had a stroke, brain injury, or spinal cord injury. Collagenase is an enzyme that breaks down collagen, a part of connective tissue. The study will measure changes in your spasticity using a tool called the Modified Ashworth Scale (MAS) and track any side effects. You may be able to join if you are 18 to 75 years old, are at least 6 months past your injury, and have a certain level of spasticity (MAS score of 1 or higher). You cannot join if you are allergic to XIAFLEX, are changing certain medications, or have recently had other spasticity treatments or surgery. The current recruitment status is unclear, and the study plans to enroll 15 participants.
- Study design
- This is an interventional study with a planned enrollment of 15 participants. The phase of the study is not specified.
- What's involved
- You would receive XIAFLEX Collagenase injections and have follow-up visits at 2 days, 2 weeks, 1 month, and 3 months after the injections.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety and spasticity changes from baseline to 3 months post-injections.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Collagenase Injection for Spasticity Management
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Sheng Li, MD, PhD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Change in spasticity as assessed by the Modified Ashworth Scale (MAS)Baseline before the intervention, follow up visits at 2 days (24 to 72 hours), 2 weeks, 1 month and 3 months post-injections
The Modified Ashworth Scale (MAS) evaluates the increase in muscle tone associated with upper motor neuron lesions. MAS scores will be recorded for the target muscle group(s) at each assessment time point.Scores range from 0 to 4, with an additional grade of 1+ between 1 and 2. Scores are defined as: 0 = no increase in muscle tone; 1 = slight increase in muscle tone with a catch and release or minimal resistance at the end of the range of motion; 1+ = slight increase in muscle tone with a catch followed by minimal resistance through less than half of the range of motion; 2 = more marked increase in muscle tone through most of the range of motion, but the affected part is easily moved; 3 = considerable increase in muscle tone, passive movement difficult; 4 = affected part rigid in flexion or extension.Lower MAS scores indicate reduced spasticity and improved muscle tone, whereas higher scores indicate greater spasticity.
- Safety as assessed by the number of adverse eventsFrom baseline to end of study (3 months post-injections)
Adverse events include 1. Serious complications of XIAFLEX injection include tendon rupture, serious ligament damage, or skin laceration that may result in the inability to fully bend the joint and may require surgery to correct the complication. 2. XIAFLEX injection is likely to result in swelling, bruising, bleeding, and/or pain of the injected site and surrounding tissue.