Collagenase Injection for Spasticity Management
ConditionSpasticity
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe University of Texas Health Science Center, Houston
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 6 months post stroke, brain injury or spinal cord injury, medically stable;
MAS ≥ 1
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
XIAFLEX Collagenase injection
Biological/VaccineCollagenase 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.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Active XIAFLEX Collagenase injectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in spasticity as assessed by the Modified Ashworth Scale (MAS)
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.
Time frame
Baseline before the intervention, follow up visits at 2 days (24 to 72 hours), 2 weeks, 1 month and 3 months post-injections2
Safety as assessed by the number of adverse events
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.
Time frame
From baseline to end of study (3 months post-injections)Secondary outcomes
1
Change in range of motion of target joints as assessed by the Passive Range of Motion (PROM)
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.
Time frame
Baseline before the intervention, follow up visits at 2 days (24 to 72 hours), 2 weeks, 1 month and 3 months post-injections2
Change in range of motion of target joints as assessed by the Active Range of Motion (AROM)
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.
Time frame
Baseline before the intervention, follow up visits at 2 days (24 to 72 hours), 2 weeks, 1 month and 3 months post-injectionsSponsors and contacts
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Source ClinicalTrials.gov
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