ECAP-controlled, Closed-loop Stimulation to Treat Chronic Trunk and/or Limb Pain (ECAP)
NCT ID: NCT04319887
Last Updated: 2024-12-31
Study Results
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View full resultsBasic Information
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COMPLETED
NA
300 participants
INTERVENTIONAL
2020-10-29
2023-12-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ECAP-controlled, closed-loop SCS
Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude
Evoke Spinal Cord Stimulation (SCS) System
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
Interventions
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Evoke Spinal Cord Stimulation (SCS) System
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
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Inclusion Criteria
* Subject is willing and capable of giving informed consent and able to comply with study-related requirements, procedures, and visits.
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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Saluda Medical Pty Ltd
INDUSTRY
Responsible Party
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Locations
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University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Coastal Pain and Spinal Diagnostics
Carlsbad, California, United States
Pacific Research Institute
Santa Rosa, California, United States
The Orthopaedic Institute, PA
Gainesville, Florida, United States
Alliance Spine and Pain Centers
Atlanta, Georgia, United States
Southern Pain and Spine
Fayetteville, Georgia, United States
Axis Spine Center
Hayden Lake, Idaho, United States
University of Kansas Medical Center Research Institute
Kansas City, Kansas, United States
Ochsner Clinic
New Orleans, Louisiana, United States
Interventional Spine and Pain Physicians
Maple Grove, Minnesota, United States
Nevada Advanced Pain Specialists
Reno, Nevada, United States
Albany Medical College
Albany, New York, United States
Duke University
Durham, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Spinal Diagnostics, PC
Tualatin, Oregon, United States
Delaware Valley Pain & Spine Institute
Feasterville-Trevose, Pennsylvania, United States
Center for Interventional Pain and Spine
Lancaster, Pennsylvania, United States
Sprintz Center for Pain PLLC
Shenandoah, Texas, United States
Precision Spine Care
Tyler, Texas, United States
St. Francis Hospital
Charleston, West Virginia, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CLIN-PCL-006732
Identifier Type: -
Identifier Source: org_study_id