Early Pharmacological Treatment of Acute Spasticity After Spinal Cord Injury

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

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 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.

Eligibility criteria

Qualifiers

Male or female aged 18 years or older

Blunt (non-penetrating) traumatic SCI

AIS grade A to D

NLI between C0 and L1

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Early baclofen Intervention
  • Usual routine care

Treatment groups

55 Participants
are divided into 2 treatment groups