Evidence map›Paper›PMID 41505067›Full record

ArticlePain and therapy2026

Next-Generation SCS Programming Platform: Enhancing ECAP Fidelity and Objectivity to Improve Patient Experience.

Daniel J Parker, Ajay B Antony, Gregory L Smith, Johnathan H Goree, Marc A Russo, Erika A Petersen, Chau M Vu, Paul Verrills, Christopher Gilmore, Leonardo Kapural and 3 more

Erratum issued 2 registry-linked trialsAbstract read
In one paragraph

Article in Pain and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04662905 narecruitingnot on this map

A Prospective, Multicentre, Single-arm Feasibility Study Examining Novel Treatment Delivery of the Evoke Spinal Cord Stimulator (SCS) System to Treat Patients With Chronic Pain of the Trunk and/or Limbs

TypeinterventionalSponsorSaluda Medical Pty LtdRan2020 to 2027Enrolled200ConditionsChronic PainArmsEvoke Spinal Cord Stimulation (SCS) System
NCT06057480 nacompletednot on this map

A Prospective, Multicenter, Single-arm Study Examining the Assisted Programming Module (APM) in the Evoke Spinal Cord Stimulation (SCS) System to Program Patients With Chronic Pain of the Trunk and/or Limbs

TypeinterventionalSponsorSaluda Medical Pty LtdRan2023 to 2024Enrolled30ConditionsChronic Pain, Pain, ChronicArmsAPM
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors.

Daniel J ParkerSaluda Medical, Level 2/5 Eden Park Dr, Macquarie Park, NSW, 2113, Australia. daniel.parker@saludamedical.com.ORCID http://orcid.org/0000-0002-7739-7697
Ajay B AntonyThe Orthopaedic Institute, Gainesville, FL, USA.
Gregory L SmithUniversity of Arkansas for Medical Sciences, Little Rock, AR, USA.
Johnathan H GoreeUniversity of Arkansas for Medical Sciences, Little Rock, AR, USA.
Marc A RussoHunter Specialist Medical Centre, Broadmeadow, NSW, Australia.
Erika A PetersenUniversity of Arkansas for Medical Sciences, Little Rock, AR, USA.
Chau M VuEvolve Restorative Center, Santa Rosa, CA, USA.
Paul VerrillsMetro Pain Group, Melbourne, Australia.
Christopher GilmoreCarolinas Pain Institute, Winston-Salem, NC, USA.
Leonardo KapuralCarolinas Pain Institute, Winston-Salem, NC, USA.
Darayus NanavatiSaluda Medical, Level 2/5 Eden Park Dr, Macquarie Park, NSW, 2113, Australia.
Dean M KarantonisSaluda Medical, Level 2/5 Eden Park Dr, Macquarie Park, NSW, 2113, Australia.
Jason E PopeEvolve Restorative Center, Santa Rosa, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionEvoked compound action potentials (ECAPs) are neurophysiological biomarkers of neural activation during spinal cord stimulation (SCS). Clear distinction between ECAPs and nonphysiological signals is critical to the application of contemporary, ECAP-based closed-loop (CL) SCS therapies. Herein, we evaluated the performance and user acceptability of a novel programming software that automates generation of ECAP-based CL-SCS programs-the Assisted Programming Module (APM).

methodsWe report results from two prospective, multicenter, single-arm, feasibility studies: Freshwater (NCT04662905) and Rosella (NCT06057480). APM performance was compared with the previous generation programming software and other published methods. Performance was assessed by comparing signal-to-noise ratios, artifact rejection, and other objective parameters. User acceptability was assessed using questionnaires administered to SCS users.

resultsThe APM successfully generated a CL program in 96% of initial programming sessions (n = 81/84; Freshwater, 31/34; Rosella, 50/50). In the Rosella study, median time to generate an automated CL program (n = 68) was 11.9 min [interquartile range (IQR) 9.9-14.0]. Median dose ratio was 1.31 (IQR 1.20-1.46) at end of trial (n = 24), 1.34 (IQR 1.13-1.51) at 1 month post implant (n = 16), and 1.32 (IQR 1.21-1.48) at 3 months post implant (n = 15). At least 90% of patients [trial, 90% (27/30); implant, 94% (17/18)] were satisfied with their programming experience, and ≥ 90% of patients [trial, 90% (26/29); implant, 94% (16/17)] felt in control of their therapy. The APM achieved a mean signal-to-noise ratio of 4.6 ± 1.2, a 35% improvement over the previous generation ECAP dose-controlled CL-SCS system. Detectable artifact leakage rates decreased by 75% when compared with other published methods without compromise to signal-to-noise performance.

conclusionsNext-generation ECAP dose-controlled CL technology demonstrated strong feasibility, high patient satisfaction and therapy control, and superior ECAP signal fidelity compared with existing methods. By standardizing CL-SCS programming and enhancing signal fidelity, the APM may improve workflow efficiency and long-term therapy outcomes in chronic pain management.

trial registrationClinicalTrials.gov identifiers: NCT04662905, NCT06057480.

Indexed as

Automated programmingChronic painClosed-loop neuromodulationECAPSpinal cord stimulation

Identifiers

PMID41505067
PMCPMC13009299

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.