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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECAP-controlled, closed-loop SCS | Experimental | Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evoke Spinal Cord Stimulation (SCS) System | Device | ECAP-controlled, closed-loop SCS |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Evoke Compound Action Potentials (ECAPs) as measured by the Evoke SCS System | Through study completion, up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
N/A
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Affairs | Contact | 16512084223 | angela.leitner@saludamedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Angela M Leitner | Saluda Medical Pty Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ACT Pain Centre | Recruiting | Garran | Australian Capital Territory | 2605 | Australia | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41505067 | Derived | 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. |
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| Sydney Pain Specialists |
| Recruiting |
| Bella Vista |
| New South Wales |
| 2153 |
| Australia |
| Genesis Research Services | Recruiting | Broadmeadow | New South Wales | 2292 | Australia |
| Northern Integrated Pain Management | Recruiting | Charlestown | New South Wales | 2290 | Australia |
| Australian Medical Research | Recruiting | Hurstville | New South Wales | 2220 | Australia |
| Inner West Pain Centre | Recruiting | Newtown | New South Wales | 2042 | Australia |
| Royal North Shore Hospital | Recruiting | Saint Leonards | New South Wales | 2065 | Australia |
| Northern Pain Centre | Recruiting | St Leonards | New South Wales | 2065 | Australia |
| Women's Health & Research Institute of Australia | Recruiting | Sydney | New South Wales | 2000 | Australia |
| Sydney Pain Research Centre Pty Ltd | Recruiting | Wahroonga | New South Wales | 2076 | Australia |
| Interventus Pain Specialists | Recruiting | Auchenflower | Queensland | 4066 | Australia |
| Axxon Pain Medicine | Recruiting | Brisbane | Queensland | 4000 | Australia |
| Total Pain Clinic | Recruiting | Brisbane | Queensland | 4014 | Australia |
| QPAIN | Completed | Fortitude Valley | Queensland | 4006 | Australia |
| Sunshine Coast Clinical Research | Completed | Noosa | Queensland | 4567 | Australia |
| Paul Frank Medical Services | Completed | Peregian Beach | Queensland | 4573 | Australia |
| Managing Pain Clinic | Recruiting | Robina | Queensland | 4226 | Australia |
| CerCare Pty Ltd | Recruiting | Wayville | South Australia | 5034 | Australia |
| Monash Clinical Research | Recruiting | Clayton | Victoria | 3168 | Australia |
| Precision Health | Recruiting | Doncaster East | Victoria | 3109 | Australia |
| Frankston Pain Management | Recruiting | Frankston | Victoria | 3199 | Australia |
| Pain Matrix | Recruiting | Geelong | Victoria | 3220 | Australia |
| Melbourne Pain Specialists | Recruiting | Richmond | Victoria | 3121 | Australia |
| Pain Specialists Australia | Recruiting | Richmond | Victoria | 3121 | Australia |
| PainCare Perth | Recruiting | Cottesloe | Western Australia | 6011 | Australia |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D062187 | Spinal Cord Stimulation |
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004358 | Drug Therapy |
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