ECAP-controlled, Closed-loop Stimulation to Treat Chronic Trunk and/or Limb Pain (ECAP)
ECAP
A Prospective, Multicenter, Single-arm Study Examining ECAP-controlled, Closed-loop Stimulation With the Evoke Spinal Cord Stimulator (SCS) System to Treat Patients With Chronic Pain of the Trunk and/or Limbs
1 other identifier
interventional
300
1 country
22
Brief Summary
The purpose of this study is to evaluate neurophysiological measures and clinical outcomes of the Evoke System to treat trunk and/or limb pain in a real-world population.
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 Oct 2020
Longer than P75 for not_applicable chronic-pain
22 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
March 17, 2020
CompletedFirst Posted
Study publicly available on registry
March 24, 2020
CompletedStudy Start
First participant enrolled
October 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 28, 2023
CompletedResults Posted
Study results publicly available
December 31, 2024
CompletedDecember 31, 2024
December 1, 2024
3.2 years
March 17, 2020
November 7, 2024
December 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evoked Compound Action Potentials (ECAPs) as Measured by the Evoke SCS System
Dose ratio is determined by the estimated current (mA) at the median ECAP level divided by the current (mA) at the ECAP threshold. The dose ratio allows for both the individualization of a patient's neural dose and comparison across patients, using their ECAP threshold and unique dose response. This metric normalizes for distance between the electrode and the spinal cord and the distances between the stimulation and recording electrodes. The dose ratio reflects the amount of dorsal column activation elicited by stimulation with respect to threshold levels. For example, if the dose is at ECAP threshold, this value will be 1. If the dose is 30% higher than ECAP threshold, this value will be 1.3.
12-months post-implant
Other Outcomes (6)
Change in Pain
end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant
Change in PROMIS-29
end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant
Change in PROMIS-10 Global
end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant
- +3 more other outcomes
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
A spinal cord stimulation system that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude
Eligibility Criteria
You may qualify if:
- Subject has chronic intractable pain of the trunk and/or limbs.
- Subject is willing and capable of giving informed consent and able to comply with study-related requirements, procedures, and visits.
You may not qualify if:
- Subject is unable to operate the system.
- Subject is an unsuitable surgical candidate.
- Subject has a condition currently requiring or likely to require the use of diathermy.
- Subject has another implantable stimulator such as demand type pacemakers or cardioverter defibrillator.
- Subject is \<18 years old.
- Subject is pregnant or nursing.
- Subject is allergic, or has shown hypersensitivity, to any materials of the neurostimulation system which come in contact with the body.
- Subject is being treated with electroconvulsive therapy (ECT) or transcranial magnetic stimulation (rTMS).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Coastal Pain and Spinal Diagnostics
Carlsbad, California, 92009, United States
Pacific Research Institute
Santa Rosa, California, 95403, United States
The Orthopaedic Institute, PA
Gainesville, Florida, 32607, United States
Alliance Spine and Pain Centers
Atlanta, Georgia, 30326, United States
Southern Pain and Spine
Fayetteville, Georgia, 30214, United States
Axis Spine Center
Hayden Lake, Idaho, 83835, United States
University of Kansas Medical Center Research Institute
Kansas City, Kansas, 66160, United States
Ochsner Clinic
New Orleans, Louisiana, 70121, United States
Interventional Spine and Pain Physicians
Maple Grove, Minnesota, 55369, United States
Nevada Advanced Pain Specialists
Reno, Nevada, 89511, United States
Albany Medical College
Albany, New York, 12208, United States
Duke University
Durham, North Carolina, 27705, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Spinal Diagnostics, PC
Tualatin, Oregon, 97062, United States
Delaware Valley Pain & Spine Institute
Feasterville-Trevose, Pennsylvania, 19053, United States
Center for Interventional Pain and Spine
Lancaster, Pennsylvania, 55419, United States
Sprintz Center for Pain PLLC
Shenandoah, Texas, 77384, United States
Precision Spine Care
Tyler, Texas, 75701, United States
St. Francis Hospital
Charleston, West Virginia, 25301, United States
Related Publications (1)
Pope JE, Antony A, Petersen EA, Rosen SM, Sayed D, Hunter CW, Goree JH, Vu CM, Bhandal HS, Shumsky PM, Bromberg TA, Smith GL, Lam CM, Kalia H, Lee JM, Khurram A, Gould I, Karantonis DM, Deer TR. Identifying SCS Trial Responders Immediately After Postoperative Programming with ECAP Dose-Controlled Closed-Loop Therapy. Pain Ther. 2024 Oct;13(5):1173-1185. doi: 10.1007/s40122-024-00631-4. Epub 2024 Jul 9.
PMID: 38977651DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Angela Leitner
- Organization
- Saluda Medical
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
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
March 17, 2020
First Posted
March 24, 2020
Study Start
October 29, 2020
Primary Completion
December 28, 2023
Study Completion
December 28, 2023
Last Updated
December 31, 2024
Results First Posted
December 31, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share