Early Pharmacological Treatment of Acute Spasticity After Spinal Cord Injury
Key facts
- Phase
- Phase 4
This trial has no sites in United States.
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Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Trial code
- NCT06564714
- Record updated
- 21 August 2024
- Original description
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 neurofunctional recovery after tSCI.Read full original descriptionShow less
Early Pharmacological Treatment of Acute Spasticity After Spinal Cord Injury to Promote Long-term Neurofunctional Recovery: a Randomized Clinical Trial
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 neurofunctional recovery after tSCI.
The main questions it aims to answer are :
1. Assess the safety of early baclofen treatment during acute care after SCI. 2. Compare the neurofunctional outcomes between the early baclofen group and the control group up to 6 months after tSCI, in terms of mobility, global functional independence, neurological recovery, pain and spasticity.
The early baclofen group will receive oral administration of baclofen as soon as any sign of acute spasticity is observed. The dose is started initially at 5 mg three times a day and is increased every 7 days by 5 mg per intake (up to a maximum 80 mg total per day) until achieving an optimal response, i.e. when spasticity is no longer problematic. The control group however will receive the "usual routine care" at our institution as per which baclofen is initiated by the attending physician (i.e. physiatrist or spine surgeon) only when acute spasticity becomes severe and problematic.
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.); Cauda equina syndrome or NLI below L1; Pre-existing neurological disorders (cerebrovascular disease, Parkinson's disease, multiple sclerosis, etc.); Renal insufficiency; Contraindication to oral baclofen use (needs clearance from attending physician and pharmacological consultant); AIS grade E upon admission; Penetrating tSCI (from stab wound, gunshot injury, etc.); Moderate or severe brain injury (mild traumatic brain injury not an exclusion criteria); Major cognitive deficits precluding informed consent and/or assessments; Unlikely to comply with scheduled visits (e.g. living in another country).