RECRUITING

Peripheral Modulation of Muscle Stiffness and Spasticity

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Peripheral Modulation of Muscle Stiffness and Spasticity

Quick Facts

Study Start:2021-10-11
Study Completion:2025-11-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03306615

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ischemic or hemorrhagic stroke 4-180 months prior
  2. * Moderately-severe muscle stiffness
  3. * Lack of full passive and active range of motion in at least 2/4 areas (shoulder, elbow, forearm, wrist) in the hemiparetic upper limb;
  4. * Willingness to have MRI, complete all clinical assessments, and comply with study protocols;
  5. * Ability to give informed consent and HIPPA certifications; and
  1. * 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;
  2. * other neurologic condition that may affect motor response (e.g., Parkinson's disease, ALS, MS);
  3. * clinically significant cognitive dysfunction with score \<19 on Folstein's Mini Mental Status Examination or depression with score \>10 on the PHQ-9;
  4. * pregnancy;
  5. * known hypersensitivity to hyaluronidase;
  6. * claustrophobia;
  7. * standard contraindications for MRI
  8. * Any condition that will preclude the patient from completing the protocol as determined by the PI

Contacts and Locations

Study Contact

Azin Etemadimanesh, MD
CONTACT
410-955-1347
aetemad2@jhmi.edu
Robert Nickl, PhD
CONTACT
4109551381
rnickl1@jhmi.edu

Principal Investigator

Ning Cao, MD
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Ning Cao, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-11
Study Completion Date2025-11-16

Study Record Updates

Study Start Date2021-10-11
Study Completion Date2025-11-16

Terms related to this study

Keywords Provided by Researchers

  • Muscle Stiffness
  • Muscle Spasticity
  • Stroke
  • Cerebral Palsy
  • Hyperreflexia

Additional Relevant MeSH Terms

  • Muscle Spasticity