Novel Intermittent Dosing Burst Paradigm in Spinal Cord Stimulation

Abstract

Introduction: Intermittent dosing (ID), in which periods of stimulation-on are alternated with periods of stimulation-off, is generally employed using 30 sec ON and 90 sec OFF intervals with burst spinal cord stimulation (SCS). The goal of this study was to evaluate the feasibility of using extended stimulation-off periods in patients with chronic intractable pain.Materials and Methods: This prospective, multicenter, feasibility trial evaluated the clinical efficacy of the following ID stimulation-off times: 90, 120, 150, and 360 sec with burst waveform parameters. After a successful trial (≥50% pain relief) using ID stimulation, subjects were titrated with OFF times beginning with 360 sec. Pain, quality of life, disability, and pain catastrophizing were evaluated at one, three, and six months after permanent implant.Results: Fifty subjects completed an SCS trial using ID stimulation settings of 30 sec ON and 90 sec OFF, with 38 (76%) receiving ≥50% pain relief. Pain scores were significantly reduced from baseline at all time points (p < 0.001). Improvements in quality of life, disability, and pain catastrophizing were aligned with pain relief outcomes; 45.8% of the subjects that completed the six-month follow-up visit used an OFF period of 360 seconds.Conclusions: ID burst SCS effectively relieved pain for six months. The largest group of subjects used IDB settings of 30 sec ON and 360 sec OFF. These findings present intriguing implications for the optimal "dose" of electricity in SCS and may offer many advantages such as optimizing the therapeutic window, extending battery life, reducing recharge burden and, potentially, mitigating therapy habituation or tolerance.

Pulse Dosing of 10-kHz Paresthesia-Independent Spinal Cord Stimulation Provides the Same Efficacy with Substantial Reduction of Device Recharge Time

“…They observed a dominant mode of 30 seconds ON and 360 seconds OFF, an 8.3% cycling ratio. This duration of 6 minutes OFF stimulation is in keeping with our results [ 14 ].…”

“…In electrical stimulation, it is tempting to think of stimulation “charge” as the prescribed “dose” [ 14 , 17 ]. However, this seems an overly simplistic view, without theoretical basis, and might wrongly suggest that any of amplitude, pulse width, frequency, duration, or timing of applied stimulation can be chosen to titrate therapy.…”

A Call to Action Toward Optimizing the Electrical Dose Received by Neural Targets in Spinal Cord Stimulation Therapy for Neuropathic Pain

“…This work was expanded by Deer et al, albeit with more nuanced duty cycle interval programming that involved alternating 30 seconds on with up to 360 seconds off. 44 After 6 months, nearly half the patients selected the 30:360 ratio of stimulation and had good therapeutic outcomes.…”

Improved Psychosocial and Functional Outcomes and Reduced Opioid Usage Following Burst Spinal Cord Stimulation

“…Recent research has shown the benefits of optimizing clinical settings for B-SCS. The BOLD study revealed that lower-energy, intermittent doses of burst stimulation are as effective as continuous burst stimulation, thereby potentially mitigating therapy habituation (42).…”