Clinical Utility of Neurophysiological Measurements of ECAP-controlled Closed-loop SCS to Guide Treatment of Chronic Pain

Running, not enrolling · Not applicable

Conditions studied: Chronic Pain

In brief

The purpose of this study is to evaluate the clinical utility of neurophysiological measurements of ECAP-controlled closed-loop SCS (i.e., neural panel metrics) to guide treatment of chronic pain of the trunk and/or limbs.

Key facts

Study ID

NCT06229470

Run by

Saluda Medical Pty Ltd

People needed

250

Starts

2024-03-08

Expected to finish

2027-02-28

Last updated by the study team

2026-05-19

Who can join

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

You may qualify if…

• Subject is planning to have a temporary trial with the Evoke System to aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome and/or intractable low back pain and leg pain.
• Leg pain score ≥ 6 cm (Visual Analog Scale [VAS]).
• Back pain score ≥ 6 cm (VAS).
• Subject is able to speak, read, and/or understand English, willing and capable of giving informed consent, and able to comply with study-related requirements, procedures, and visits.
• Subject is not pregnant and not <18 years of age.

You may not qualify if…

• N/A

Where it is running

• Lakeside Spine and Pain — Lake Havasu City, Arizona, United States
• Spanish Hills Interventional Pain Specialists — Camarillo, California, United States
• Pain Consultants of San Diego — La Mesa, California, United States
• Pacific Research Institute — Santa Rosa, California, United States
• Boomerang Healthcare — Walnut Creek, California, United States
• DBPS Research — Greenwood Village, Colorado, United States
• Pohlman Pain Associates — Delray Beach, Florida, United States
• Horizon Clinical Research — Jasper, Georgia, United States
• Rockford Pain Center — Rockford, Illinois, United States
• Goodman Campbell Brain and Spine — Carmel, Indiana, United States
• Metro Anesthesia & Pain Management — Des Moines, Iowa, United States
• Restorative Pain Institute — Louisville, Kentucky, United States
• Advanced Pain Institute — Hammond, Louisiana, United States
• Spine and Joint Institute — Glen Burnie, Maryland, United States
• Michigan Pain Specialists — Ann Arbor, Michigan, United States
• Pain Clinic of Michigan — Rochester Hills, Michigan, United States
• Tricity Research Center, LLC — Grand Island, Nebraska, United States
• Reno Tahoe Pain Associates — Reno, Nevada, United States
• Garden State Pain and Orthopedics — Clifton, New Jersey, United States
• Seaside Clinical Research Institute — Wilmington, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Premier Pain Treatment Institute — Loveland, Ohio, United States
• Carolinas Center for Advanced Management of Pain — Greenville, South Carolina, United States
• Institute of Precision Pain Medicine — Corpus Christi, Texas, United States
• Victoria Pain and Rehabilitation Center — Victoria, Texas, United States

Full record on ClinicalTrials.gov

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