Hyaluronidase injections for muscle stiffness and spasticity
Peripheral Modulation of Muscle Stiffness and Spasticity
This study is testing if hyaluronidase injections can help reduce muscle stiffness and improve movement in people who have had a stroke.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT03306615 on ClinicalTrials.gov |
What this trial studies
This Phase II trial investigates the effects of human recombinant hyaluronidase injections on upper limb muscle stiffness and spasticity in individuals who have experienced a stroke. The study involves 56 participants who will receive either the hyaluronidase treatment or a placebo in a randomized, double-blind manner. The primary outcomes include improvements in passive range of motion, muscle strength, and motor function, as well as reductions in muscle stiffness. Participants will receive both treatments by the end of the study, allowing for a comprehensive evaluation of the intervention's effects.
Who should consider this trial
Good fit: Ideal candidates are individuals who have experienced an ischemic or hemorrhagic stroke 4-180 months prior and have moderately-severe muscle stiffness in their upper limb.
Not a fit: Patients currently receiving other spasticity treatments or those with significant cognitive dysfunction or other neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve mobility and quality of life for patients with muscle stiffness and spasticity following a stroke.
How similar studies have performed: While the use of hyaluronidase for muscle stiffness is a novel approach, similar studies targeting muscle spasticity have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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, 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 this trial is running
Baltimore, Maryland
- Johns Hopkins School of Medicine — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Ning Cao, MD — Johns Hopkins University
- Study coordinator: Azin Etemadimanesh, MD
- Email: aetemad2@jhmi.edu
- Phone: 410-955-1347
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.