Actively Recruiting

Early Phase 1
Age: 18Years - 80Years
All Genders
Healthy Volunteers
NCT06666673

Effect of Neural Constraints on Movement in Stroke

Led by Northwestern University · Updated on 2025-05-14

64

Participants Needed

1

Research Sites

257 weeks

Total Duration

On this page

Sponsors

N

Northwestern University

Lead Sponsor

E

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Effect of Neural Constraints on Movement in Stroke

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • History of unilateral supratentorial ischemic stroke at least six months before enrollment
  • Age between 18 and 80 years
  • Paresis on one side with substantial motor impairment of the upper limb and some voluntary movement (Fugl-Meyer Assessment 15-45/66, Chedoke McMaster Hand score ≤4)
  • Ability to communicate, understand, and provide informed consent
  • Ability to lift affected limb against gravity to at least 75 degrees shoulder flexion and actively extend elbow
  • MRI compatibility
  • Intact skin on the affected arm
  • Ability to sit for three hours
Not Eligible

You will not qualify if you...

  • Motor or sensory impairment in the unaffected limb (Fugl-Meyer Assessment <66, filament >3.6)
  • Any brainstem or cerebellar lesion
  • Untreated cardiovascular disease
  • Neurologic disorders other than stroke affecting arms
  • Acute or chronic pain in upper limbs or spine with pain score ≥5 on 10-point scale
  • Current pacemaker use
  • History of seizures
  • Botulinum toxin injection to affected upper limb within past 6 months or phenol/alcohol injection within past 12 months
  • Flexion contractures over 30 degrees in elbow, wrist, or finger joints after 15 minutes stretching
  • Current participation in experimental rehabilitation or drug studies
  • Known contraindications to Tizanidine or current Tizanidine use
  • Concurrent use of medications suppressing central nervous system activity
  • Pregnant or nursing women

AI-Screening

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Trial Site Locations

Total: 1 location

1

Northwestern University, Dept. of PTHMS 645 N Michigan Ave, Suite 1100

Chicago, Illinois, United States, 60611

Actively Recruiting

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Research Team

R

Riegele Arceo

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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