Status:
RECRUITING
Peripheral Modulation of Muscle Stiffness and Spasticity
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Sheikh Khalifa Stroke Institute
Conditions:
Muscle Spasticity
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 stiffne...
Detailed Description
1. To test the effect of hyaluronidase injections on upper limb outcomes. The investigators will test the hypothesis that compared to placebo, human recombinant hyaluronidase injections will increase ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT03306615
Start Date
October 11 2021
End Date
June 30 2026
Last Update
December 4 2025
Active Locations (1)
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1
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21231