RECRUITING

Single Dose Monoaminergic Drive in Stroke

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 study investigates the effects of Tizanidine on the voluntary movement controls of the arms of participants who have had a stroke and have not had a stroke by measuring medication-induced changes in upper extremity kinematics, pupillometry, and brain activity. Tizanidine is approved by the U.S. Food and Drug Administration. Understanding how different areas of the brain are involved in movement impairments may help rehabilitation efforts and assist in restoring healthy movement in individuals who have had a stroke.

Official Title

Single Dose Monoaminergic Drive in Stroke

Quick Facts

Study Start:2024-08-23
Study Completion:2029-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06666673

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 to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * History of unilateral supratentorial ischemic stroke that occurred at least six months prior to enrollment
  2. * Age between 18-80
  3. * Paresis confined to one side, with substantial motor impairment of the upper limb and some residual voluntary movement (Upper Extremity Fugl-Meyer Assessment in the range of 15-45/66, Chedoke McMaster Stroke Assessment Hand section \<=4)
  4. * Ability to communicate, understand, and provide informed consent
  5. * Ability to elevate their limb against gravity up to at least 75 degrees of shoulder flexion and to generate active elbow extension
  6. * MRI compatible
  7. * Intact skin on the hemiparetic arm
  8. * Ability to sit for three hours.
  1. * Motor or sensory impairment in the non-affected limb (FMA\<66, filament \>3.6)
  2. * Any brainstem and/or cerebellar lesion
  3. * untreated cardiovascular disease
  4. * History of neurologic disorder other than stroke that affects the arms
  5. * Any acute or chronic painful condition in the upper extremities or spine, indicated by a score ≥5 on a 10-point visual analog scale
  6. * Current use of a pacemaker
  7. * History of seizure
  8. * Chemo denervation: botulinum toxin injection to any portion of the paretic upper extremity within the last 6 months, or phenol/alcohol injections \<12 months before participation
  9. * Flexion contractures larger than 30 degrees in the elbow, wrist, metacarpophalangeal joints (MCP) and interphalangeal joints (IP) after stretching for 15 minutes
  10. * Current participation in any experimental rehabilitation or drug studies
  11. * Individuals with any known contraindications to Tizanidine or currently taking Tizanidine; - concurrent use of medications known to suppress central nervous system activity
  12. * pregnant women or women who are nursing.

Contacts and Locations

Study Contact

Riegele Arceo
CONTACT
3129080847
riegele.arceo@northwestern.edu

Principal Investigator

Julius Dewald, DPT, PhD
PRINCIPAL_INVESTIGATOR
Northwestern University
Jun Yao, PhD
PRINCIPAL_INVESTIGATOR
Northwestern University

Study Locations (Sites)

Northwestern University, Dept. of PTHMS 645 N Michigan Ave, Suite 1100
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Northwestern University

  • Julius Dewald, DPT, PhD, PRINCIPAL_INVESTIGATOR, Northwestern University
  • Jun Yao, PhD, PRINCIPAL_INVESTIGATOR, Northwestern 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 Date2024-08-23
Study Completion Date2029-07-31

Study Record Updates

Study Start Date2024-08-23
Study Completion Date2029-07-31

Terms related to this study

Keywords Provided by Researchers

  • Neurotransmitters
  • flexion synergy
  • brain plasticity
  • tizanidine
  • stroke
  • motor control
  • spasticity

Additional Relevant MeSH Terms

  • Stroke