Intermittent Dosing of Spinal Cord Stimulation as Alternate Paradigm to Continuous 10kHz Frequency Therapy (HF10 Therapy)

Spinal cord stimulation (SCS) delivered at 10kHz frequency (HF10 Therapy) has demonstrated superiority to traditional SCS for leg and back pain. This mode of stimulation entails delivery of a greater charge per second compared to traditional tonic spinal cord stimulation and corresponding implications for battery usage. Although not yet studied in novel modes of SCS such as HF10 and Burst3 due to their relative infancy, the possibility of decreased pain relief over time very much exists. This has been well-documented with the use of tonic spinal cord stimulation. Furthermore, the most common cause of spinal cord stimulator explant remains the lack or loss of efficacy. In order to mitigate the potential for waning pain relief over time and downstream consequences of increased charge burden, other paradigms of stimulation within the framework of HF10 therapy must be evaluated.

Intermittent dosing (ID) refers to the cycling of stimulation, in which there is a designated time period of stimulation being active (ON) and inactive (OFF). Previous studies have demonstrated the safe and effective use of intermittent dosing. In 2020, Deer et al. reported the efficacy of intermittent dosing of Burst stimulation with settings ranging from 30 seconds ON and 90 seconds OFF, to 30 seconds ON and 360 seconds OFF. In this 50 subject study, 45.8% of patients preferred stimulation with 30 seconds ON and 360 seconds OFF. However, there still remains a paucity of clinical data on the use of intermittent dosing and which doses (i.e. on/off cycle time periods) are most effective. Furthermore, no previous studies have utilized HF10 therapy when evaluating intermittent dosing.

This study seeks to prospectively compare continuous HF10 therapy versus two intermittent dosing HF10 (ID HF10) therapies - 1) 30 seconds ON and 120 seconds OFF; 2) 30 seconds ON and 360 seconds OFF - in patients endorsing decreasing efficacy of continuous HF10 therapy.

We hypothesize that ID HF10 therapy will provide non-inferior pain relief as measured by NRS scores when compared to continuous HF10 therapy. The primary outcome for this study will be NRS pain scores (0 to 10 where 0 = no pain and 10 = worst pain ever in 0.5 increments). Secondary endpoints include: charging frequency, EQ-5D scores of wellbeing, PROMIS scores for physical function, pain interference, sleep disturbance, and emotional distress; chronic pain acceptance questionnaire 8 (CPAQ-8), patient satisfaction scores, and patient global impression of change.

Patients with chronic back and/or leg pain who have undergone permanent spinal cord stimulator implantation delivered by the Nevro Omnia Neurostimulation System, have had the system in place for at least 1 year, utilizing continuous HF10 therapy, and now endorsing decreasing efficacy of continuous HF10 therapy will be randomized to 2 groups, in a single-blinded, 1:1 fashion: