Peripheral Modulation of Muscle Stiffness and Spasticity
Running, not enrolling · Phase 2 · Has a placebo group
Conditions studied: Muscle Spasticity
In brief
This is a single-center, double-blind, randomized, placebo-controlled, sequential Phase II trial of human recombinant hyaluronidase injections in individuals with post-stroke upper limb muscle stiffness. The investigators will recruit 56 subjects, who will be randomized to receive either the intervention or normal saline injections (first injection), and then the intervention the participants did not receive first (second injection). All individuals will receive the treatment by the end of the study.
Key facts
- Study ID
- NCT03306615
- Run by
- Johns Hopkins University
- People needed
- 56
- Starts
- 2021-10-11
- Expected to finish
- 2027-06-26
- Last updated by the study team
- 2026-06-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Ischemic or hemorrhagic stroke 4-180 months prior
- Moderately-severe muscle stiffness
- Lack of full passive and active range of motion in at least 2/4 areas (shoulder, elbow, forearm, wrist) in the hemiparetic upper limb;
- Willingness to have MRI, complete all clinical assessments, and comply with study protocols;
- Ability to give informed consent and HIPPA certifications; and
You may not qualify if…
- treatment of spasticity with Botulinum toxin or intrathecal baclofen within the past six months, phenol injections within the past 12 months, or ongoing adjustment of anti-spastic medications;
- other neurologic condition that may affect motor response (e.g., Parkinson's disease, amyotrophic lateral sclerosis (ALS), MS);
- clinically significant cognitive dysfunction with score <19 on Folstein's Mini Mental Status Examination or depression with score >10 on the Patient Health Questionnaire-9 (PHQ-9);
- pregnancy;
- known hypersensitivity to hyaluronidase;
- claustrophobia;
- standard contraindications for MRI
- Any condition that will preclude the patient from completing the protocol as determined by the PI
Where it is running
- Johns Hopkins School of Medicine — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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