Differential target multiplexed spinal cord stimulation using a paddle‑type lead placed at the appropriate site for neuropathic pain after spinal cord injury in patients with past spinal surgical histories: study protocol for an exploratory clinical trial

This study aims to see if a new type of spinal cord stimulation (SCS), called differential target multiplexed (DTM) stimulation, can help people with neuropathic pain after spinal cord injury (SCI) who have had spinal surgery before. The study will use a paddle-type lead placed on the rostral side of the SCI, which researchers believe is a more effective location than the caudal side where leads are often placed in patients with prior surgeries. The trial involves two steps: first, a temporary SCS trial to test the effectiveness of DTM stimulation versus conventional tonic stimulation; second, implantation of a permanent SCS system if the trial shows promising results.

• 1
  The primary outcome will be the rate of pain improvement, defined as a 33% or greater reduction in pain scores, three months after SCS system implantation.
• 2
  Secondary outcomes include evaluating the effectiveness of DTM versus tonic stimulation during the SCS trial, changes in pain, mental health, and gait function over 24 months.
• 3
  The study also aims to identify preoperative factors associated with long-term effectiveness of SCS and to assess whether gait function improves with SCS.