Early Pharmacological Treatment of Acute Spasticity After Spinal Cord Injury

Launched by CENTRE INTEGRE UNIVERSITAIRE DE SANTE ET SERVICES SOCIAUX DU NORD DE L'ILE DE MONTREAL · Aug 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether starting treatment with a medication called baclofen right after a spinal cord injury (SCI) can help reduce spasticity—uncontrolled muscle tightness—and improve recovery. Spasticity can be a common problem after a spinal cord injury, and the goal is to see if treating it early with baclofen can lead to better outcomes in movement and overall function. Participants will be divided into two groups: one group will receive baclofen as soon as they show signs of spasticity, while the other group will receive standard care, where baclofen is given only if the spasticity becomes severe.

To be eligible for this trial, participants need to be at least 18 years old and have experienced a blunt spinal cord injury, with certain conditions in place regarding the severity and type of injury. Individuals with certain medical conditions or those unlikely to attend follow-up visits may not qualify. If you join the study, you can expect to take oral baclofen, starting with a low dose that may be increased over time, and you'll be monitored for safety and improvement in your physical abilities for up to six months. This trial is not yet recruiting participants, but it aims to find better ways to manage spasticity and improve recovery in individuals with spinal cord injuries.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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