Early Pharmacological Treatment of Acute Spasticity After Spinal Cord Injury (NCT06564714) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Early Pharmacological Treatment of Acute Spasticity After Spinal Cord Injury
Canada55 participantsStarted 2024-12
Plain-language 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 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Spinal Cord Independence Measure (SCIM)
Timeframe: 6 months after the injury
2
Adverse Events
Timeframe: From acute care to 6 months after the injury,
Trial details
NCT IDNCT06564714
SponsorCentre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal