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At a Glance
Age
18 – 80
Sex
Any
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Basic Science
Participants needed
64 (estimated)
Sponsor
Northwestern University · Other
Who this trial is looking for
This trial is looking for participants who have had a stroke at least six months ago and have some difficulty moving their arms. Taking part involves receiving a medication called Tizanidine and undergoing assessments of movement and brain activity.
Are You a Good Fit for This Trial?
You may be able to join if
I had a stroke more than six months ago.
I am between 18 and 80 years old.
I have some movement in one arm but it is weak.
I can understand and communicate clearly.
I can lift my arm up at least 75 degrees.
My skin on the weak arm is intact.
I can sit still for three hours.
You may not be able to join if
I have problems moving or feeling in my other arm.
I have any lesions in my brainstem or cerebellum.
I have untreated heart disease.
I have had a seizure before.
I have ongoing pain in my arms or spine.
I use a pacemaker.
I have had certain injections in my arm recently.
I am pregnant or nursing.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 moveme…
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.
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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 A…
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 10-50/66)
* 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.
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