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Recruiting NCT04662905

Novel Treatment Delivery of ECAP-controlled Closed-loop SCS for Chronic Pain

No phase Interventional Chronic Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Evoke Spinal Cord Stimulation (SCS) System.
Who it may be relevant to
Registry conditions: Chronic Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

The purpose of this study is to test and evaluate novel treatment delivery of ECAP-controlled closed loop SCS through the incorporation of new software and/or hardware features for patients with the Evoke System.

Interventions

  • Device Evoke Spinal Cord Stimulation (SCS) System
    ECAP-controlled, closed-loop SCS

Primary outcome measures

  • Change in Evoke Compound Action Potentials (ECAPs) as measured by the Evoke SCS System [Time frame: Through study completion, up to 2 years]

Eligibility criteria

Inclusion criteria

  • 1\. Subject has undergone trial implant or is planning to be implanted with the Evoke System within its approved indication.
  • 2\. Subject is willing and capable of giving informed consent and able to comply with study-related requirements.

Exclusion criteria

N/A

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Australia · 25 centers
  • ACT Pain Centre — Garran
  • Sydney Pain Specialists — Bella Vista
  • Genesis Research Services — Broadmeadow
  • Northern Integrated Pain Management — Charlestown
  • Australian Medical Research — Hurstville
  • Inner West Pain Centre — Newtown
  • Royal North Shore Hospital — Saint Leonards
  • Northern Pain Centre — St Leonards
  • … and 17 more centers

Publications

  • Parker DJ, Antony AB, Smith GL, Goree JH, Russo MA, Petersen EA, Vu CM, Verrills P, Gilmore C, Kapural L, Nanavati D, Karantonis DM, Pope JE. Next-Generation SCS Programming Platform: Enhancing ECAP Fidelity and Objectivity to Improve Patient Experience. Pain Ther. 2026 Apr;15(2):465-480. doi: 10.1007/s40122-025-00808-5. Epub 2026 Jan 8. PMID 41505067

Identifiers

NCT: NCT04662905 · CLIN-PCL-007873

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗