NCT05179473 Prognosis and Diagnosis of Spasticity in Acute-post Stroke Patients
| NCT ID | NCT05179473 |
| Status | Recruiting |
| Phase | — |
| Sponsor | McGill University |
| Condition | Stroke, Acute |
| Study Type | OBSERVATIONAL |
| Enrollment | 12 participants |
| Start Date | 2021-06-17 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 12 participants in total. It began in 2021-06-17 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Spasticity, or greater muscle resistance, is a major disabling condition following stroke. Recovery of lost motor function in patients with stroke may be affected by spasticity, which most commonly develops in elbow and ankle muscles. However, despite its clinical relevance, the natural development of spasticity over the first 3 months after stroke is not clearly understood. Indeed, common clinical measures of spasticity such as the Modified Ashworth Scale (MAS) do not take into account the neurophysiological origin of spasticity and lack reliability and objectivity. The objective of this study is to examine the natural history of the development of spasticity among patients with stroke over the first 3 months using a new neurophysiological measure (TSRT, the tonic stretch reflex threshold angle) and its velocity sensitivity (mu) in comparison to MAS and other common clinical tests. In addition, detailed brain imaging will be used to understand the relationship between damage to brain regions relevant to the development of spasticity and TSRT/mu values. It is hypothesized that 1) TSRT/mu will indicate the presence of spasticity earlier than MAS/clinical tests; 2) TSRT/mu measures will be more closely related to motor impairments and activity limitations than MAS; 3) the lesion severity (identified by imaging) will be related to the change in TSRT/mu values. Outcomes will be measured in a pilot cohort of 12 patients hospitalized for first-ever stroke. Measurements will be taken at the bedside within the 1st week of the patient's admission and will be done once per week for 12 weeks with a follow-up at week 16. Brain Imaging will be done around the 6th week post-stroke.
Eligibility 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
Contact & Investigator
Theodore Wein, MD
PRINCIPAL INVESTIGATOR
Montreal Neurological Institute
Frequently Asked Questions
Who can join the NCT05179473 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Stroke, Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05179473 currently recruiting?
Yes, NCT05179473 is actively recruiting participants. Contact the research team at mindy.levin@mcgill.ca for enrollment information.
Where is the NCT05179473 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT05179473 clinical trial?
NCT05179473 is sponsored by McGill University. The principal investigator is Theodore Wein, MD at Montreal Neurological Institute. The trial plans to enroll 12 participants.
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