Defining the Boundaries of Patient Perception in Spinal Cord Stimulation Programming

John Hatheway; Michael Yang; Michael Fishman; Michael Verdolin; Tory McJunkin; Steven Rosen; Sean Slee; Andrew Kibler; Kasra Amirdelfan

doi:10.1016/j.neurom.2023.08.011

Defining the Boundaries of Patient Perception in Spinal Cord Stimulation Programming

Neuromodulation. 2024 Jan;27(1):108-117. doi: 10.1016/j.neurom.2023.08.011. Epub 2023 Dec 16.

Authors

John Hatheway¹, Michael Yang², Michael Fishman³, Michael Verdolin⁴, Tory McJunkin⁵, Steven Rosen⁶, Sean Slee⁷, Andrew Kibler⁸, Kasra Amirdelfan⁹

Affiliations

¹ Northwest Pain Care, PS, Spokane, WA, USA.
² Summit Pain Alliance, Santa Rosa, CA, USA.
³ Center for Interventional Pain and Spine, Lancaster, PA, USA.
⁴ Pain Consultants of San Diego, La Mesa, CA, USA.
⁵ Arizona Pain Specialists, Scottsdale, AZ, USA.
⁶ Delaware Valley Pain and Spine Institute, Trevose, PA, USA.
⁷ BIOTRONIK NRO Inc., Lake Oswego, OR, USA.
⁸ BIOTRONIK NRO Inc., Lake Oswego, OR, USA. Electronic address: andrew.kibler@gmail.com.
⁹ Boomerang Healthcare, Walnut Creek, CA, USA.

PMID: 38108675
DOI: 10.1016/j.neurom.2023.08.011

Abstract

Objectives: Recent developments in spinal cord stimulation (SCS) programming have initiated new modalities of imperceptible stimulation. However, the boundaries of sensory perception are not well defined. The BEnchtop NEuromodulation Following endIng of Trial study aimed to create a map of perceptual threshold responses across a broad range of SCS parameters and programming to inform subperception therapy design.

Materials and methods: This multicenter study was conducted at seven US sites. A total of 43 patients with low back and/or leg pain who completed a percutaneous commercial SCS trial were enrolled. Test stimulation was delivered through trial leads for approximately 90 minutes before removal. SCS parameters, including amplitude, frequency, pulse width (PW), electrode configuration, cycling, and multifrequency stimulation were varied during testing. Paresthesia threshold (PT), comfort level (CL), perceptual coverage area, and paresthesia quality (through patient selection of keywords) were collected. Differences were evaluated with analysis of variance followed by post hoc multiple comparisons using t-tests with Bonferroni correction.

Results: PT was primarily determined by PW and was insensitive to frequency for constant frequency stimulation (range: 20 Hz-10 kHz; F(1284) = 69.58, p < 0.0001). For all tests, CL was approximately 25% higher than PT. The dominant variable that influenced paresthesia quality was frequency. Sensations described as comfortable and tingling were most common for frequencies between 60 Hz and 2.4 kHz; unpleasant sensations were generally more common outside this range. Increasing distance between active electrodes from 7 mm to 14 mm, or cycling the SCS waveform at 1 Hz, decreased PT (p < 0.0001). Finally, PT for a low-frequency stimulus (ie, 60 Hz) was unaffected by mixing with a sub-PT high-frequency stimulus.

Conclusions: In contrast to previous work investigating narrower ranges, PW primarily influenced PT, independently of frequency. Paresthesia quality was primarily influenced by pulse frequency. These findings advance our understanding of SCS therapy and may be used to improve future novel neuromodulation paradigms.

Keywords: Cycling; SCS; electrode configuration; paresthesia threshold; perception.

Publication types

Multicenter Study

MeSH terms

Chronic Pain* / therapy
Humans
Pain
Pain Management
Paresthesia / etiology
Paresthesia / therapy
Perception
Spinal Cord
Spinal Cord Stimulation*
Treatment Outcome