Predicting and diagnosing spasticity after acute stroke
Changing Practice: Prognosis and Diagnosis of Spasticity in Acute-post Stroke Patients: a Pilot Study
We will test whether a new neurophysiological measure (TSRT and its velocity sensitivity, mu) can detect and track developing spasticity during the first three months after an acute middle cerebral artery stroke in people with arm or leg weakness.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | McGill University Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT05179473 on ClinicalTrials.gov |
What this trial studies
This is an observational follow-up of patients with acute middle cerebral artery (MCA) strokes who develop hemiparesis, tracking spasticity over the first three months. Investigators will use a new neurophysiological measure (tonic stretch reflex threshold angle, TSRT, and its velocity sensitivity mu) alongside common clinical tests such as the Modified Ashworth Scale to compare timing and severity of spasticity. Detailed brain imaging will be performed to relate lesion location and extent to later spasticity development. The primary goal is to describe the natural history of post-stroke spasticity and determine whether TSRT/mu provides earlier or more objective detection than routine clinical measures.
Who should consider this trial
Good fit: Adults with a recent acute ischemic or hemorrhagic stroke in the middle cerebral artery territory causing hemiparesis, who are medically stable and able to give informed consent, are the intended participants.
Not a fit: Patients with severe cognitive disorders or ataxia, chronic stroke beyond the early post-stroke period, or strokes outside the MCA territory are unlikely to benefit from or be eligible for this protocol.
Why it matters
Potential benefit: If successful, this could enable earlier, more objective detection of post-stroke spasticity and guide timely rehabilitation or treatments to reduce long-term disability.
How similar studies have performed: Routine clinical scales like the Modified Ashworth Scale are widely used but limited, and using TSRT and mu is relatively novel though prior neurophysiological work suggests potential value.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Acute stroke in Middle Cerebral Artery area resulting in hemiparesis. * Hemorrhagic or ischemic * Medically stable * Able to provide informed consent Exclusion Criteria: * Severe cognitive disorders * Ataxia
Where this trial is running
Montreal, Quebec
- Jewish General Hospital — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Theodore Wein, MD — Montreal Neurological Institute
- Study coordinator: Mindy F. Levin, PT, PhD
- Email: mindy.levin@mcgill.ca
- Phone: 450-688-9550
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.