Study Comparing New Time Variant Pulse Patterns to Standard Time Invariant Pulse Stimulation for Spinal Cord Stimulation in Chronic Pain Treatment

What this Trial Is About

This research aims to compare how well spinal cord stimulation SCS works using new time varying pulse TVP patterns versus the current standard time-invariant pulse TIP patterns in people with chronic or neuropathic pain. The study explores both paresthesia and paresthesia-free SCS therapies and evaluates how long the effects of these stimulation patterns last. Participants will be randomly assigned to receive either the standard TIP stimulation or the experimental TVP stimulation, which varies in intensity or rate. TIP stimulation uses fixed settings for amplitude, pulse width, and frequency, while TVP stimulation adjusts these parameters dynamically. The study includes a long-term follow-up phase to track therapy effectiveness over time using multiple pain assessments and data collected digitally at home. During the study, participants will be monitored through pain questionnaires and other assessments at baseline and during three experimental stimulation periods, each lasting approximately 8 weeks. Researchers will measure changes in patient responder rates compared to baseline to evaluate pain outcomes. The study involves device use, adherence tracking, and safety monitoring throughout. Participation lasts through these treatment and follow-up phases, allowing detailed observation of therapy effects.

Novel Stimulation Patterns to Improve the Effectiveness of Spinal Cord Stimulation