APM in the Evoke SCS System to Program Patients With Chronic Pain of the Trunk and/or Limbs
APM
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
1 other identifier
interventional
30
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable chronic-pain
Started Sep 2023
4 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
September 15, 2023
CompletedStudy Start
First participant enrolled
September 26, 2023
CompletedFirst Posted
Study publicly available on registry
September 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 19, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 19, 2024
CompletedMay 15, 2025
May 1, 2025
1.2 years
September 15, 2023
May 12, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (1)
APM
EXPERIMENTALInvestigational programming software module, the Assisted Programming Module (APM)
Interventions
Eligibility Criteria
You may qualify if:
- Subject has or is planning to undergo a temporary trial with Evoke System within the FDA approved indication.
- Subject is willing and capable of giving informed consent and able to comply with study-related requirements.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Pacific Research Institute
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
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
Condition Hierarchy (Ancestors)
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
September 15, 2023
First Posted
September 28, 2023
Study Start
September 26, 2023
Primary Completion
December 19, 2024
Study Completion
December 19, 2024
Last Updated
May 15, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share