Sustained Long-Term Outcomes With Closed-Loop Spinal Cord Stimulation: 12-Month Results of the Prospective,...

Area of Science:

• Neuromodulation
• Pain Management
• Biomedical Engineering

Background:

• Spinal cord stimulation (SCS) traditionally uses fixed-output electrical stimuli.
• Current SCS systems do not adapt to individual spinal cord (SC) activation levels.

Purpose of the Study:

• To evaluate the long-term outcomes of a closed-loop SCS system.
• To assess the system's ability to maintain SC activation within a patient-specific therapeutic window.
• To measure pain relief and functional improvements in patients with chronic back and/or leg pain.

Main Methods:

• A closed-loop SCS system (Evoke) was implanted in 50 patients.
• Spinal cord (SC) activation was monitored via evoked compound action potential (ECAP) amplitude.
• Pain, quality of life, function, sleep, and medication use were assessed over time.
• The therapeutic window was defined by ECAP amplitude thresholds.

Main Results:

• 81.4% of patients achieved overall ≥50% pain relief at 12 months.
• 53.5% of patients experienced ≥80% overall pain relief.
• Patients spent a median of 84.9% of their time within their therapeutic window.
• 68.8% of patients reduced or eliminated opioid use.

Conclusions:

• The closed-loop SCS system demonstrates long-term effectiveness in pain management.
• Stable SC activation, measured by ECAP, correlates with sustained pain relief.
• The Evoke system offers a promising approach for personalized chronic pain treatment.