ECAP-controlled, Closed-loop Stimulation to Treat Chronic Trunk and/or Limb Pain (ECAP)

Completed · Not applicable

Conditions studied: Chronic Pain, Back Pain, Pain

In brief

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.

Key facts

Study ID

NCT04319887

Run by

Saluda Medical Pty Ltd

People needed

300

Starts

2020-10-29

Expected to finish

2023-12-28

Last updated by the study team

2024-12-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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).

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.