Early Pharmacological Treatment of Acute Spasticity After Spinal Cord Injury
- Conditions
- Traumatic Spinal Cord Injury
- Registration Number
- NCT06564714
- Lead Sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 55
Inclusion Criteria:<br><br> - Male or female aged 18 years or older<br><br> - Blunt (non-penetrating) traumatic SCI<br><br> - AIS grade A to D<br><br> - NLI between C0 and L1<br><br> - Patient willing and able to provide informed consent<br><br>Exclusion Criteria:<br><br> - Non-traumatic SCI (e.g. tumor, infection, transverse myelitis, etc.)<br><br> - AIS grade E upon admission<br><br> - Penetrating tSCI (from stab wound, gunshot injury, etc.)<br><br> - Cauda equina syndrome or NLI below L1<br><br> - Moderate or severe brain injury (mild traumatic brain injury not an exclusion<br> criteria)<br><br> - Contraindication to oral baclofen use (needs clearance from attending physician and<br> pharmacological consultant)<br><br> - Pre-existing neurological disorders (cerebrovascular disease, Parkinson's disease,<br> multiple sclerosis, etc.)<br><br> - Major cognitive deficits precluding informed consent and/or assessments<br><br> - Unlikely to comply with scheduled visits (e.g. living in another country)<br><br> - Renal insufficiency
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Spinal Cord Independence Measure (SCIM);Adverse Events
- Secondary Outcome Measures
Name Time Method Spastic reflexe assessment;Muscle Spasticity assessment;Spasticity frequency;Spasticity impact;Neurological Assessment;Functional Assessment and Independent Walking;Pain Assessment