Early Pharmacological Treatment of Acute Spasticity After Spinal Cord Injury

Drug
Spasticity
Online since 25 October 2024, updated 97 days ago

About this 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 neurofunc...

Included participants

Gender
All
Age
≥ 18 years
Injury level
C1 - L1
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≤ 1 month
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C1-L1
    Additionally, participants must
    NOT have pre-existing neurological disorders (cerebrovascular disease, Parkinson's disease, multiple sclerosis, etc.)
    NOT have a penetrating traumatic SCI

    What’s involved

    Type

    Drug

    Details

    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 in the chronic stage 6 months or more after the injury. (1-4). After SCI, spasticity is due to a stretch reflex disorder of sensorimotor control following an upper motor neuron lesion, i.e. a lesion involving the neurons carrying the information within the spinal cord. Clinically, spasticity manifests as a complex syndrome of velocity-dependent hypertonia, clonus (rhythmic oscillating stretch reflex) and spasms (involuntary muscle contractions) that can have profound consequences on function and quality of life. Traditionally, the clinical impact of spasticity has been mostly recognized during the subacute and chronic phases after SCI. Based upon the current management paradigm, the great majority of individuals with spasticity will receive pharmaceutical treatment for spasticity only during the rehabilitation period weeks or months after the injury when the clinical manifestations become severe and problematic. The investigators have challenged this long-held belief by proposing their paradigm shift towards early recognition and treatment of spasticity during the acute within the first month after SCI, after showing that about half of individuals will develop clinical signs of early spasticity during the acute hospitalization, and that acute spasticity is associated with poor long-term outcomes. In particular, the investigators found that long-term mobility is significantly decreased in individuals presenting acute spasticity within the first month after the SCI. Our preliminary data suggest that prompt pharmacological treatment with baclofen - an anti-spasmodic medication - during the acute hospitalization improves neurological recovery in the presence of acute spasticity. Based on these preliminary findings, the overarching hypothesis of this study is that long-term neurofunctional outcomes are improved by early detection of acute spasticity and immediate treatment with oral baclofen. Our team of experienced clinician-scientists specialized in SCI care therefore propose a single-site pilot randomized clinical trial including 55 patients admitted for a traumatic SCI (tSCI), in order to evaluate the safety and neurofunctional benefits of early baclofen treatment (i.e. as soon as any signs of spasticity are observed within the first month after the injury) during the acute hospitalization.

    Potential benefits

    Main benefits

    Spasticity

    Additional benefits

    Arm/hand function

    Bladder health/function

    Bone health

    General health

    Pain

    Sensory function

    Standing/walking/mobility

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more

    • Trial recruitment status
    • Recruiting soon
    • Trial start date
    • 1 Dec 2024
    • Organisation
    • Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
    • Trial recruitment status
    • Recruiting soon
    • Trial start date
    • 1 Dec 2024
    • Organisation
    • Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more