Peripheral Modulation of Muscle Stiffness and Spasticity
Details
Status
Open: Currently recruiting participants.
Closed: Recruitment either has not started or has paused or completed.
Study Type
Interventional (clinical trials): Test treatments.
Observational: Conduct surveys and interviews, study medical records and otherwise observe people or groups over time.
Interventional
Study Phase
Each study phase tests different aspects of the medication or treatment:
- Phase I: safety and dosing
- Phase II: effectiveness and side effects
- Phase III: efficacy compared to standard treatments
- Phase IV: long-term safety after approval for use
II
Location(s)
Johns Hopkins study sites. Additional study locations may be found on ClinicalTrials.gov.
The Johns Hopkins Hospital
1800 Orleans St Baltimore, MD 21287
Keywords
Contact Us
Research_Recruitment@jh.eduBrief 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 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.
Eligibility
Inclusion Criteria:
- 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 Criteria:
- 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, ALS, MS);
- clinically significant cognitive dysfunction with score <19 on Folstein's Mini Mental Status Examination or depression with score >10 on the 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