Novel Treatment Delivery of ECAP-controlled Closed-loop SCS for Chronic Pain
Freshwater
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
1 other identifier
interventional
200
1 country
23
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable chronic-pain
Started Dec 2020
Longer than P75 for not_applicable chronic-pain
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2020
CompletedFirst Posted
Study publicly available on registry
December 10, 2020
CompletedStudy Start
First participant enrolled
December 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
May 13, 2025
May 1, 2025
6 years
November 30, 2020
May 12, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Evoke Compound Action Potentials (ECAPs) as measured by the Evoke SCS System
Through study completion, up to 2 years
Study Arms (1)
ECAP-controlled, closed-loop SCS
EXPERIMENTALSpinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude
Interventions
ECAP-controlled, closed-loop SCS
Eligibility Criteria
You may qualify if:
- \. Subject has undergone trial implant or is planning to be implanted with the Evoke System within its approved indication.
- \. Subject is willing and capable of giving informed consent and able to comply with study-related requirements.
You may not qualify if:
- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
ACT Pain Centre
Garran, Australian Capital Territory, 2605, Australia
Sydney Pain Specialists
Bella Vista, New South Wales, 2153, Australia
Genesis Research Services
Broadmeadow, New South Wales, 2292, Australia
Northern Integrated Pain Management
Charlestown, New South Wales, 2290, Australia
Australian Medical Research
Hurstville, New South Wales, 2220, Australia
Inner West Pain Centre
Newtown, New South Wales, 2042, Australia
Royal North Shore Hospital
Saint Leonards, New South Wales, 2065, Australia
Northern Pain Centre
St Leonards, New South Wales, 2065, Australia
Women's Health & Research Institute of Australia
Sydney, New South Wales, 2000, Australia
Sydney Pain Research Centre Pty Ltd
Wahroonga, New South Wales, 2076, Australia
Interventus Pain Specialists
Auchenflower, Queensland, 4066, Australia
Axxon Pain Medicine
Brisbane, Queensland, 4000, Australia
Total Pain Clinic
Brisbane, Queensland, 4014, Australia
QPAIN
Fortitude Valley, Queensland, 4006, Australia
Sunshine Coast Clinical Research
Noosa, Queensland, 4567, Australia
Paul Frank Medical Services
Peregian Beach, Queensland, 4573, Australia
CerCare Pty Ltd
Wayville, South Australia, 5034, Australia
Monash Clinical Research
Clayton, Victoria, 3168, Australia
Frankston Pain Management
Frankston, Victoria, 3199, Australia
Pain Matrix
Geelong, Victoria, 3220, Australia
Melbourne Pain Specialists
Richmond, Victoria, 3121, Australia
Pain Specialists Australia
Richmond, Victoria, 3121, Australia
PainCare Perth
Cottesloe, Western Australia, 6011, Australia
Related Publications (1)
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 Jan 8. doi: 10.1007/s40122-025-00808-5. Online ahead of print.
PMID: 41505067DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Angela M Leitner
Saluda Medical Pty Ltd
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2020
First Posted
December 10, 2020
Study Start
December 15, 2020
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
May 13, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share