Status:
NOT_YET_RECRUITING
Early Pharmacological Treatment of Acute Spasticity After Spinal Cord Injury
Lead Sponsor:
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Conditions:
Traumatic Spinal Cord Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The objective of this clinical trial is to evaluate if early detection of spasticity and immediate treatment with oral baclofen during acute care prevents problematic spasticity and improves neurofunc...
Detailed Description
Spasticity is a condition in which muscles are abnormally stiff or tight, and interfere with normal movement. Following spinal cord injury (SCI), spasticity is common, affecting up to 70% of patients ...
Eligibility Criteria
Inclusion
- Male or female aged 18 years or older
- Blunt (non-penetrating) traumatic SCI
- AIS grade A to D
- NLI between C0 and L1
- Patient willing and able to provide informed consent
Exclusion
- Non-traumatic SCI (e.g. tumor, infection, transverse myelitis, etc.)
- AIS grade E upon admission
- Penetrating tSCI (from stab wound, gunshot injury, etc.)
- Cauda equina syndrome or NLI below L1
- Moderate or severe brain injury (mild traumatic brain injury not an exclusion criteria)
- Contraindication to oral baclofen use (needs clearance from attending physician and pharmacological consultant)
- Pre-existing neurological disorders (cerebrovascular disease, Parkinson's disease, multiple sclerosis, etc.)
- Major cognitive deficits precluding informed consent and/or assessments
- Unlikely to comply with scheduled visits (e.g. living in another country)
- Renal insufficiency
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT06564714
Start Date
December 1 2024
End Date
June 1 2029
Last Update
August 21 2024
Active Locations (1)
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1
CIUSSS du Nord-de-l'île-de-Montréal-Hôpital du Sacré-Cœur de Montréal
Montreal, Quebec, Canada, H4J 1C5