(AS1) Study Protocol: A Feasibility Study of Spinal Cord Stimulation (SCS) for Improving Pain and Rehabilitation Outcomes in Patients with Spinal Cord Injury (SCI)

Introduction: Individuals with spinal cord injury (SCI) may have altered quality of life based on their remaining motor and sensory function, neuropathic pain, and bladder dysfunction. To date, no single treatment modality has been shown to improve outcomes in patient-reported measures, objective functional measures, and structural imaging.

Methods: This study will assess pain and rehabilitation outcomes in patients who undergo spinal cord stimulation (SCS) and/or conventional medical management (CMM). Unlike previous SCS studies, our protocol involves two separate SCS paddles: one at the thoracic level for pain and the other at the conus for functional recovery. A two-arm, randomized clinical trial of ~20 adults with a history and imaging consistent with thoracic SCI and SCI-related pain will be conducted. Patients will be assigned to either CMM or CMM+SCS groups. At baseline, as well as months 1, 3, 6, 9, and 12, outcome assessments are performed. The primary outcome is the change in Multi-Dimensional Pain Inventory for SCI at 3 months. Medication logs, bladder and pain diaries, VAS (Patients' Global Impression of Change), PROMISE 29+2, Spinal Cord Independence Measure, American Spinal Injury Association Impairment Scale, and electromyography (EMG) during muscle strength dynamometry, optical motion capture biomechanics during LiteGait-assisted locomotion, and transcranial magnetic stimulation, and diffusion tensor imaging with tractography of the brain and spine. Patients in the CMM will cross over to the CMM+SCS at 3 months for a 9-month outcome comparison to evaluate early versus late responses.

Results: We anticipate the CMM+SCS group will have more improvement in pain and rehabilitation measures compared to CMM alone. Furthermore, we anticipate that CMM+SCS early patients will outperform cross-over on these measures.

Conclusion : The current protocol evaluates patient-reported, functional, and structural outcomes in patients receiving dual SCS for SCI. Future findings aim to help improve treatment options for people with SCI.