Peripheral Modulation of Muscle Stiffness and Spasticity

Description

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.

Conditions

Muscle Spasticity

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Study Overview

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Study Details

Study overview

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.

Peripheral Modulation of Muscle Stiffness and Spasticity

Peripheral Modulation of Muscle Stiffness and Spasticity

Condition
Muscle Spasticity
Intervention / Treatment

-

Contacts and Locations

Baltimore

Johns Hopkins School of Medicine, Baltimore, Maryland, United States, 21231

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Johns Hopkins University,

Ning Cao, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

2025-11-16