Clinical Utility of Neurophysiological Measurements of ECAP-controlled Closed-loop SCS to Guide Treatment of Chronic Pain
- Conditions
- Chronic Pain
- Interventions
- Device: Evoke Spinal Cord Stimulation (SCS) System
- Registration Number
- NCT06229470
- Lead Sponsor
- Saluda Medical Pty Ltd
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 250
- 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.
- N/A
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ECAP-Controlled, Closed-Loop SCS Evoke Spinal Cord Stimulation (SCS) System Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude.
- Primary Outcome Measures
Name Time Method Change in Evoked Compound Action Potentials (ECAPs) as measured by the Evoke SCS System through 6-months post-implant physiological parameter to be measured = Evoked Compound Action Potentials (ECAPs); measurement tool = Evoke SCS System
- Secondary Outcome Measures
Name Time Method Change in Visual Analogue Scale (VAS) Pain through 6-months post-implant Visual Analogue Scale (VAS) to rate pain intensity (0mm \[no pain\] to 100mm \[worst pain imaginable\])
Change in PROMIS-29+2 through 6-months post-implant PROMIS-29 Profile and 2 PROMIS Cognitive Function Abilities items. The PROMIS-29 is a 29-item profile instrument that assesses 8 universal domains (not disease-specific): Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Pain Interference, and Pain Intensity.
Change in PROMIS-10 Global Health through 6-months post-implant 10-item instrument that assesses Physical Health and Mental Health
Trial Locations
- Locations (25)
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