Spasticity
Conditions
Brief summary
The overall goal is to investigate the effectiveness of a novel intervention - Collagenase injection, for spasticity management in patients with neurological impairments, such as stroke, brain injury, and spinal cord injury.
Interventions
BIOLOGICALXIAFLEX Collagenase injection
Collagenase is an enzyme that breaks down collagen, which is a key component of connective tissue, such as fascia. XIAFLEX is an FDA-Approved collagenase for treatment of Dupuytren's contracture with a palpable cord in the fingers, and Peyronie's disease in the penile tissue. In this research project, we plan to use collagenase to treat spasticity in patients with neurological impairments, such as stroke, brain injury, and spinal cord injury. FDA guidelines will be followed for dosing and patient selection to minimize or reduce the risks.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* ≥ 6 months post stroke, brain injury or spinal cord injury, medically stable; * MAS ≥ 1
Exclusion criteria
* Is hypersensitive to XIAFLEX or collagenase; * Is currently adjusting tone alternating medications (e.g., baclofen), or * Received botulinum toxin injection to target areas \<4 months, or phenol injections \< 9 months; * Received surgical release of tendons; * Is a pregnant woman; * Has coagulation disorders, including those who receive concomitant anticoagulants (except for low-dose aspirin). * has heritable connective tissue disorders, including those within the Ehlers-Danlos syndrome (EDS) spectrum.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 events | From 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in range of motion of target joints as assessed by the Passive Range of Motion (PROM) | Baseline before the intervention, follow up visits at 2 days (24 to 72 hours), 2 weeks, 1 month and 3 months post-injections | Range of motion (ROM) refers to the degree of movement available at a joint, measured in degrees using a goniometer. For PROM, the examiner will move the joint to its maximal pain-free range. Measurements will be recorded in degrees, and higher values indicate greater joint mobility. |
| Change in range of motion of target joints as assessed by the Active Range of Motion (AROM) | Baseline before the intervention, follow up visits at 2 days (24 to 72 hours), 2 weeks, 1 month and 3 months post-injections | Range of motion (ROM) refers to the degree of movement available at a joint, measured in degrees using a goniometer. For AROM, participants will be instructed to move the joint as far as possible without assistance. Measurements will be recorded in degrees, and higher values indicate greater joint mobility. |
Countries
United States
Contacts
CONTACTSheng Li, MD, PhD
CONTACTShengai Li, MS
PRINCIPAL_INVESTIGATORSheng Li, MD, PhD
The University of Texas Health Science Center, Houston
Outcome results
None listed