Safety and Efficacy Study of the Evoke™ SCS System With Feedback vs. Conventional Stimulation
NCT ID: NCT02924129
Last Updated: 2024-01-03
Study Results
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View full resultsBasic Information
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COMPLETED
NA
134 participants
INTERVENTIONAL
2017-01-27
2022-09-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Evoke SCS with Feedback
closed-loop/automatic stimulation
Evoke Spinal Cord Stimulator (SCS) System
Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
Evoke SCS with Conventional
open-loop/manual stimulation
Evoke Spinal Cord Stimulator (SCS) System
Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
Interventions
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Evoke Spinal Cord Stimulator (SCS) System
Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
Eligibility Criteria
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Inclusion Criteria
* Have been diagnosed with chronic, intractable pain of the trunk and/or limbs, which has been refractory to conservative therapy for a minimum of 6 months.
* Be an appropriate candidate for an SCS trial and the surgical procedures required in this study based on the clinical judgment of the Investigator.
* Be willing and capable of giving informed consent and able to comply with study-related requirements, procedures, and visits.
Exclusion Criteria
* Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention, and/or ability to evaluate treatment outcomes.
* Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker, deep brain stimulator (DBS), or sacral nerve stimulator (SNS).
* Have prior experience with SCS.
* Have an active systemic infection or local infection in the area of the surgical site.
* Be pregnant or nursing (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile, or be at least 2 years post-menopausal).
* Be concomitantly participating in another clinical study.
18 Years
80 Years
ALL
No
Sponsors
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Saluda Medical Americas, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Dan Brounstein, MBA
Role: STUDY_DIRECTOR
Saluda Medical Americas, Inc.
Locations
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Hope Research Institute
Phoenix, Arizona, United States
Arizona Pain Specialists
Scottsdale, Arizona, United States
Summit Pain Alliance
Santa Rosa, California, United States
Thrive Clinic
Santa Rosa, California, United States
IPM Medical Group
Walnut Creek, California, United States
Pain Management Associates
Lee's Summit, Missouri, United States
Premier Pain Centers
Shrewsbury, New Jersey, United States
Ainsworth Institute of Pain Management
New York, New York, United States
Center for Clinical Research
Winston-Salem, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Integrated Pain Solutions
Columbus, Ohio, United States
St. Luke's University Health Network
Bethlehem, Pennsylvania, United States
Delaware Valley Pain & Spine Institute
Feasterville-Trevose, Pennsylvania, United States
Center for Pain Relief
Charleston, West Virginia, United States
Advanced Pain Management
Greenfield, Wisconsin, United States
Countries
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References
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Mekhail NA, Levy RM, Deer TR, Kapural L, Li S, Amirdelfan K, Pope JE, Hunter CW, Rosen SM, Costandi SJ, Falowski SM, Burgher AH, Gilmore CA, Qureshi FA, Staats PS, Scowcroft J, McJunkin T, Carlson J, Kim CK, Yang MI, Stauss T, Petersen EA, Hagedorn JM, Rauck R, Kallewaard JW, Baranidharan G, Taylor RS, Poree L, Brounstein D, Duarte RV, Gmel GE, Gorman R, Gould I, Hanson E, Karantonis DM, Khurram A, Leitner A, Mugan D, Obradovic M, Ouyang Z, Parker J, Single P, Soliday N; EVOKE Study Group. ECAP-controlled closed-loop versus open-loop SCS for the treatment of chronic pain: 36-month results of the EVOKE blinded randomized clinical trial. Reg Anesth Pain Med. 2024 May 7;49(5):346-354. doi: 10.1136/rapm-2023-104751.
Kapural L, Mekhail NA, Costandi S, Gilmore C, Pope JE, Li S, Hunter CW, Poree L, Staats PS, Taylor RS, Eldabe S, Kallewaard JW, Thomson S, Petersen EA, Sayed D, Deer TR, Antony A, Budwany R, Leitner A, Soliday N, Duarte RV, Levy RM. Durable multimodal and holistic response for physiologic closed-loop spinal cord stimulation supported by objective evidence from the EVOKE double-blind randomized controlled trial. Reg Anesth Pain Med. 2024 Apr 2;49(4):233-240. doi: 10.1136/rapm-2023-104639.
Costandi S, Kapural L, Mekhail NA, Jotwani R, Bertisch SM, Li S, Petersen E, Abejon D, Poree L, Ouyang Z, Venkatesan L, Mekhail MN, Gilligan CJ. Impact of Long-Term Evoked Compound Action Potential Controlled Closed-Loop Spinal Cord Stimulation on Sleep Quality in Patients With Chronic Pain: An EVOKE Randomized Controlled Trial Study Subanalysis. Neuromodulation. 2023 Jul;26(5):1030-1038. doi: 10.1016/j.neurom.2022.10.050. Epub 2022 Nov 25.
Falowski SM, Kim CH, Obradovic M, Parker JL. A Prospective Multicenter Case Series Utilizing Intraoperative Neuromonitoring With Evoked Compound Action Potentials to Confirm Spinal Cord Stimulation Lead Placement. Neuromodulation. 2022 Jul;25(5):724-730. doi: 10.1016/j.neurom.2021.11.014. Epub 2022 Jan 26.
Mekhail N, Levy RM, Deer TR, Kapural L, Li S, Amirdelfan K, Hunter CW, Rosen SM, Costandi SJ, Falowski SM, Burgher AH, Pope JE, Gilmore CA, Qureshi FA, Staats PS, Scowcroft J, Carlson J, Kim CK, Yang MI, Stauss T, Poree L; Evoke Study Group. Long-term safety and efficacy of closed-loop spinal cord stimulation to treat chronic back and leg pain (Evoke): a double-blind, randomised, controlled trial. Lancet Neurol. 2020 Feb;19(2):123-134. doi: 10.1016/S1474-4422(19)30414-4. Epub 2019 Dec 20.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SCLSH1503
Identifier Type: -
Identifier Source: org_study_id
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