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Early outcomes with a flexible ECAP based closed loop using multiplexed spinal cord stimulation waveforms-single-arm

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This study shows a closed-loop spinal cord stimulation (CL-SCS) system effectively reduces overstimulation and improves pain relief. Patients experienced more consistent therapy, with significant pain reduction for back, leg, and upper limb pain.

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Area of Science:

  • Neuromodulation
  • Biomedical Engineering
  • Pain Management

Background:

  • Traditional spinal cord stimulation (SCS) systems deliver fixed amplitudes, leading to inconsistent electrical fields and patient discomfort due to movement.
  • Closed-loop SCS (CL-SCS) aims to provide consistent, comfortable stimulation by adjusting amplitude based on real-time physiological feedback.
  • This study investigates a CL-SCS system that utilizes spinal evoked compound action potentials to dynamically regulate stimulation.

Purpose of the Study:

  • To evaluate the performance and patient outcomes of a novel closed-loop spinal cord stimulation (CL-SCS) system.
  • To assess the system's ability to reduce overstimulation and improve pain relief compared to open-loop SCS.
  • To determine patient preference for stimulation waveforms during at-home use.

Main Methods:

  • An ongoing study involving implantation of the CL-SCS system in subjects.
  • In-clinic randomized, crossover testing of CL-SCS performance.
  • Evaluation of pain-related outcomes for up to 24 months, including 3-month follow-up visits.

Main Results:

  • The primary endpoint was met, with 89.3% of subjects reporting reduced overstimulation with CL-SCS versus open-loop SCS at 1 month.
  • At 3 months, 86% of subjects with low-back/leg pain and 100% with upper limb pain reported at least a 50% reduction in pain.
  • Sixty percent of subjects preferred below-perception waveforms for at-home therapy.

Conclusions:

  • The CL-SCS system demonstrates effective performance in delivering a consistent and comfortable therapy experience.
  • The system's ability to automatically adjust amplitude up to 50 times per second improves therapeutic consistency.
  • The findings support the use of this flexible CL-SCS system for improved pain management.