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New treatment option for Stroke
Official title Effect of Neural Constraints on Movement in Stroke
ClinicalTrials.gov ID: NCT06666673
What this study is testing
What is Tizanidine?
Tizanidine is an investigational medicine, given as an once-daily, being studied as a potential treatment for stroke.
Also referred to as Zanaflex®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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
You likely can't join if
- Motor or sensory impairment in the non-affected limb (FMA\ 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
See the full eligibility 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, Chedoke McMaster Stroke Assessment...
- 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.
- Motor or sensory impairment in the non-affected limb (FMA\ 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...
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.