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Study to evaluate the use of 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APM | Experimental | Investigational programming software module, the Assisted Programming Module (APM) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APM | Device | Investigational programming software module, the Assisted Programming Module (APM) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Evoked Compound Action Potentials (ECAPs) measured in µV by the Evoke SCS System | Change in Evoked Compound Action Potentials (ECAPs) measured in µV by the Evoke SCS System | end of trial period; 1 month and 3 months post-implant |
| Change in programming parameters (e.g., stimulation frequency [Hz], pulse width [µs], amplitude [mA]) measured by the Evoke SCS System | Change in programming parameters (e.g., stimulation frequency [Hz], pulse width [µs], amplitude [mA]) measured by the Evoke SCS System | end of trial period; 1 month and 3 months post-implant |
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States | ||
| Pacific Research Institute |
| 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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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 26, 2026 | Jun 22, 2026 | 5 |
| 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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| Santa Rosa |
| California |
| 95403 |
| United States |
| The Orthopaedic Institute, PA | Gainesville | Florida | 32607 | United States |
| Center for Clinical Research | Winston-Salem | North Carolina | 27103 | United States |