RecruitingEarly Phase 1NCT06666673

Effect of Neural Constraints on Movement in Stroke

Sponsor

Northwestern University

Enrollment

64 participants

Start Date

Aug 23, 2024

Study Type

INTERVENTIONAL

Conditions

Stroke

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria8

History of unilateral supratentorial ischemic stroke that occurred at least six months prior to enrollment
Age between 18-80
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)
Ability to communicate, understand, and provide informed consent
Ability to elevate their limb against gravity up to at least 75 degrees of shoulder flexion and to generate active elbow extension
MRI compatible
Intact skin on the hemiparetic arm
Ability to sit for three hours.

Exclusion Criteria13

Motor or sensory impairment in the non-affected limb (FMA<66, filament >3.6)
Any brainstem and/or cerebellar lesion
untreated cardiovascular disease
History of neurologic disorder other than stroke that affects the arms
Any acute or chronic painful condition in the upper extremities or spine, indicated by a score ≥5 on a 10-point visual analog scale
Current use of a pacemaker
History of seizure
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
Flexion contractures larger than 30 degrees in the elbow, wrist, metacarpophalangeal joints (MCP) and interphalangeal joints (IP) after stretching for 15 minutes
Current participation in any experimental rehabilitation or drug studies
Individuals with any known contraindications to Tizanidine or currently taking Tizanidine; - concurrent use of medications known to suppress central nervous system activity
pregnant women or women who are nursing.
Additionally, each participant will be asked to provide a list of their current medications and a medical screening questionnaire will be sent to their primary physician. Each participant's list of medications will be reviewed for possible interactions with the study drugs and, at the study physician's advice, will be excluded from the study or asked to withhold medications when applicable. A full list of potential drug interactions can be seen in "Medication Interactions", but concisely includes the following: medications with dopaminergic, serotonergic, or noradrenergic actions; central nervous system (CNS) depressants; antihypertensive/ antiarrhythmic agents; and hormonal medications/contraceptives.

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Interventions

DRUGTizanidine

Tizanidine (TIZ) (Zanaflex®) is a centrally acting noradrenergic α-2 agonist and a ligand of I3 (non-I1/I2) imidazoline receptors. It is currently indicated for the management of spasticity.

DRUGPlacebo

Administered as control