Exploratory evaluation of spinal cord stimulation with dynamic pulse patterns: a promising approach to improve stimulation sensation, coverage of pain areas, and expected pain relief.

Abstract

The societal burden of chronic pain and the contribution-in-part to the opioid crisis, is a strong motivation to improve and expand non-addictive treatments, including spinal cord stimulation (SCS). For several decades standard SCS has consisted in delivery of tonic pulses with static parameter settings in frequency, pulse width, and amplitude. These static parameters have limited ability to personalize the quality of paresthesia, the dermatomal coverage, and thus may affect SCS efficacy. Further, static settings may contribute to the build-up of tolerance or loss of efficacy of the therapy over time in some patients. We conducted an acute exploratory study to evaluate the effects of SCS using time-dynamic pulses as compared to time-static (conventional tonic) stimulation pulses, with the hypotheses that dynamic pulse SCS may enable beneficial tailoring of the sensation and the patient's expectation for better pain relief with SCS. During a single clinic visit, consented subjects undergoing a standard SCS trial had their implanted leads temporarily connected to an investigational external stimulator capable of delivering time-static and six categories of time-dynamic pulse sequences, each characterized by continuously varying a stimulation parameter. Study subjects provided several assessments while blinded to the stimulation pattern, including: drawing of paresthesia maps, descriptions of sensation, and ratings for comfort and helpfulness to pain relief. Even without optimization of the field location, a majority of subjects rated sensations from dynamic stimulation as better or equal to that of static stimulation for comfortableness and for helpfulness to pain relief. The initial data showed a gender and/or pain dermatomal location related preference to a stimulation pattern. In particular, female subjects and subjects with pain at higher dermatomes tended to rank the sensation from dynamic stimulation better. Dynamic stimulation produced greater pain coverage without optimization; in 70% (9/13) of subjects, maximal pain coverage was achieved with a dynamic stimulation pattern. There was also greater variety in the words used by patients to describe stimulation sensation in the free text and free form verbal descriptions associated with dynamic stimulation. With the same electrode configuration and comparable parameter settings, acute SCS using dynamic pulses produced more positive ratings, expanded paresthesia coverage, and greater variation in sensation as compared to SCS using static pulses, suggesting that dynamic stimulation has the potential to improve capabilities of SCS for the treatment of chronic pain. Further study is warranted. This study was registered at ClinicalTrials.gov under ID NCT02988713, November 2016 (URL: https://clinicaltrials.gov/ct2/show/NCT02988713).