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

Defining the Boundaries of Patient Perception in Spinal Cord Stimulation Programming

John Hatheway  1 , Michael Yang  2 , Michael Fishman  3 , Michael Verdolin  4 , Tory McJunkin  5 , Steven Rosen  6 , Sean Slee  7 , Andrew Kibler  8 , Kasra Amirdelfan  9
Affiliations
Free article
Multicenter Study

Defining the Boundaries of Patient Perception in Spinal Cord Stimulation Programming

John Hatheway et al. Neuromodulation. 2024 Jan.
Free article

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.

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Conflict of interest statement

Conflict of Interest John Hatheway has received funding from Medtronic, Nalu, Biotronik, and Boston Scientific. Michael Yang has consulted for and participated in research sponsored by Boston Scientific and Nevro, as well as participated in research sponsored by Saluda. Michael Fishman was a former Director for North American Neuromodulation Society and has consulted for Abbott, Neuromodulation, Aurora Pain Care, Biotronik, Bridge Therapeutics, Brixton Biosciences, Institute for Musculoskeletal Education, Medtronic, and Saluda Medical; is the cofounder of Celéri Health and Occam’s Razor and holds stock for Celéri Health, Occam’s Razor, Aurora Spine, and Thermaquil; has conducted research with Abbott, Biotronik, Boston Scientific, Foundation Fusion Solutions (Cornerloc), InterAxon, Medtronic, Nalu Medical, PainQX, Seikagaku, SGX Medical, and Thermaquil; is an employee of the Center for International Pain & Spine, and his spouse is an employee of Global Medical. Michael Verdolin has consulted for Medtronic, Vertiflex, and Boston Scientific. Tory McJunkin has consulted for Nevro and has conducted research with Nevro and Saluda. Steven Rosen has conducted research with Saluda and Boston Scientific and has consulted for Flowonix. Sean Slee and Andrew Kibler are paid employees of BIOTRONIK NRO, Inc, a subsidiary of BIOTRONIK SE & Co. KG. Kasra Amirdelfan has consulted for Medtronic, Boston Scientific, Nevro, Biotronik, and Nalu, and holds minor options for Nalu.

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