Success of spinal cord stimulation (SCS) therapy is typically measured by change in pain intensity, which insufficiently describes the patient experience.
Composite outcomes have been developed to capture the interplay between physical pain on quality of life, disability, and sleep status among other factors.
Here we report a composite outcome3associated with various closed-loop (CL) waveforms in patients with chronic low back and/or limb pain.
CL-SCS systems automatically adjust stimulation amplitude in response to sensed physiological signals to maintain consistent therapy delivery.
The CL feature is flexible in that in can be applied to tonic or multiplexed waveforms.

Prospective study being conducted at 7 sites in Australia (NCT05177354). The study has 2 parts: a) in-clinic, randomized, cross-over, single blind, testing for Primary Endpoint at 1-month and b) long-term, single-arm follow-up for pain outcomes at 3-, 6-, 12-, 18- and 24-months post Device Activation. Primary outcome has been previously described.
Additional objective of the study is characterizing a multidimensional composite outcome at 18-months

CL-SCS can successfully be programmed to a variety of waveforms and reduce the need for manual amplitude adjustments.
Significant and sustained improvements were observed in Pain, Physical Function, and Quality of Life through 18-months.
Final 24M outcomes are forthcoming to evaluate the long-term benefits of this flexible CL-SCS platform.