Effect of Neural Constraints on Movement in Stroke

Launched by NORTHWESTERN UNIVERSITY · Oct 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called Tizanidine on the movement of the arms in people who have experienced a stroke. The goal is to understand how this medication can help improve voluntary movement by looking at changes in arm movement, pupil response, and brain activity. Tizanidine is already approved for use, and the findings could help in developing better rehabilitation strategies for stroke survivors.

To be eligible for the study, participants should be between the ages of 18 and 80 and must have had a stroke at least six months ago that affected one side of their body, resulting in some difficulty using their arm. Participants should be able to understand and communicate well, and they should be able to move their arm against gravity. Throughout the trial, individuals will be monitored for how the medication affects their movement and brain activity. It’s important to note that participants will need to provide a list of their current medications to ensure there are no harmful interactions with Tizanidine. The study is currently recruiting participants, so if you or someone you know meets these criteria and is interested, it could be a valuable opportunity to contribute to stroke rehabilitation research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.