Peripheral Modulation of Muscle Stiffness and Spasticity

Launched by JOHNS HOPKINS UNIVERSITY · Oct 9, 2017

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment for muscle stiffness and spasticity in the upper limbs of individuals who have had a stroke. Researchers want to see if injections of hyaluronidase, a substance that may help relax stiff muscles, can improve movement and reduce stiffness compared to a placebo (a substance with no active treatment). The study will involve 50 participants, aged 65 to 74, who will be randomly assigned to receive either the hyaluronidase injection or a saline (saltwater) solution. Over about nine weeks, participants will attend several visits to receive injections, undergo assessments, and have MRI scans to monitor changes.

To be eligible, participants should have experienced a stroke between 4 to 180 months ago and suffer from moderately severe muscle stiffness that limits movement in at least two areas of the arm. They should be willing to undergo MRI scans and complete all study requirements. However, individuals currently receiving certain spasticity treatments, those with other neurological conditions, or those who are pregnant cannot participate. Importantly, all participants will eventually receive the treatment, ensuring that everyone has the chance to benefit from the study.

Gender

ALL

Eligibility 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