NCT06666673RecruitingEarly phase 1
Effect of Neural Constraints on Movement in Stroke
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 64 (estimated)
- First submitted
- 10 Oct 2024
- Start date
- 23 Aug 2024
- Primary completion date
- 30 Jun 2029
- Lead sponsor
- Northwestern University
- Diseases
- Stroke
- NCT number
- NCT06666673
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 64
- From 23 Aug 2024 to the primary completion date, 30 Jun 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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.
Other illness
- Motor or sensory impairment in the non-affected limb (FMA\<66, filament \>3.6)
- 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
- History of seizure
Other
- Any brainstem and/or cerebellar lesion
- Current use of a pacemaker
- Flexion contractures larger than 30 degrees in the elbow, wrist, metacarpophalangeal joints (MCP) and interphalangeal joints (IP) after stretching for 15 minutes
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Northwestern University, Dept. of PTHMS 645 N Michigan Ave, Suite 1100 Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.