Design and protocol for the decompression-plus trial: a phase 1 clinical study of dorsal myelotomy and expansive duroplasty with or without autologous nerve grafting in acute traumatic spinal cord injury.

Abstract

Background: Traumatic spinal cord injury (tSCI) is a devastating condition marked by persistent neurologic deficits. Secondary injury processes following tSCI, including progressive hemorrhagic necrosis and elevated intraspinal pressure (ISP), contribute to ongoing neurologic deterioration. Existing therapeutic strategies have shown limited efficacy, emphasizing the critical need for innovative interventions. This phase 1 study introduces a novel approach involving dorsal myelotomy and expansive duroplasty (DMED) with or without autologous nerve graft implantation (ANGI) for acute tSCI. The study aims to specifically assess the safety, feasibility, and preliminary efficacy of DMED and ANGI ("Decompression-Plus"). Inspired by cranial trauma management, expansive duroplasty represents a promising approach given that the dura can propagate ischemic injury. ANGI provides a unique opportunity for cell-based therapy without the logistical challenges associated with cell culture, allografts, or immunosuppression.

Methods: A total of 10 participants presenting to the emergency department and diagnosed with acute ASIA impairment scale A/B cervico-thoracic tSCI will be consented and blinded prior to undergoing either DMED alone or Decompression-Plus (1:1 ratio). Rigorous monitoring of adverse events with institutional data safety monitoring board oversight will be performed through regular clinical, laboratory, and imaging evaluations. Feasibility will be assessed by monitoring of recruitment rates, procedural adherence, and participant compliance. Clinical outcomes will be measured by American Spinal Injury Association impairment scale assessments.

Conclusion: DMED with or without ANGI represent novel interventions for managing acute tSCI. The results of this phase 1 trial will determine whether these interventions can be performed safely and feasibly in a consecutive cohort of patients to potentially enhance recovery and improve outcomes.

Trial registration numbers: Clinicaltrials.gov - NCT06243211 ( https://clinicaltrials.gov/study/NCT06243211?term=NCT06243211&rank=1 ) and UK Institutional Review Board - 91630.