Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain Using Summit RCS

What this Trial Is About

Chronic pain affects many adults and is often resistant to existing treatments. This research explores a novel approach using closed-loop deep brain stimulation DBS that targets multiple brain regions involved in different pain dimensions. The goal is to develop personalized DBS technology that adapts to each patients pain signals, potentially offering more lasting relief for treatment-resistant chronic pain. Participants begin with an inpatient trial where temporary electrodes are placed bilaterally in brain areas linked to pain perception. This stage helps identify personalized pain biomarkers and optimal stimulation settings. A subgroup showing potential benefit will then receive permanent implants targeting up to three brain regions for long-term monitoring and stimulation. The study compares active closed-loop DBS against inactive stimulation in a randomized, blinded crossover design using devices such as the Medtronic Summit RCS or Percept RC. Throughout the trial, participants undergo brain recordings and stimulation sessions monitored over weeks and months. Researchers assess pain, mood, and functional outcomes using clinical scores and sensory testing. Safety and adverse events are tracked for two years. The study aims to validate neural signals predicting pain fluctuations and test the feasibility and effectiveness of personalized closed-loop DBS for chronic pain management.

Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain