Status:
COMPLETED
ECAP-controlled, Closed-loop Stimulation to Treat Chronic Trunk and/or Limb Pain (ECAP)
Lead Sponsor:
Saluda Medical Pty Ltd
Conditions:
Chronic Pain
Back Pain
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
October 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2023
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04319887
Start Date
October 29 2020
End Date
December 28 2023
Last Update
December 31 2024
Active Locations (22)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
2
Coastal Pain and Spinal Diagnostics
Carlsbad, California, United States, 92009
3
Pacific Research Institute
Santa Rosa, California, United States, 95403
4
The Orthopaedic Institute, PA
Gainesville, Florida, United States, 32607