Clinical Utility of Neurophysiological Measurements of ECAP-controlled Closed-loop SCS to Guide Treatment of Chronic Pain
Neural Panel
A Prospective, Multicenter, Single-arm Study Evaluating the Clinical Utility of Neurophysiological Measurements of ECAP-controlled Closed-loop Spinal Cord Stimulation (SCS) to Guide Treatment of Patients With Chronic Pain of the Trunk and/or Limbs.
1 other identifier
interventional
250
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable chronic-pain
Started Mar 2024
Typical duration for not_applicable chronic-pain
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2024
CompletedFirst Posted
Study publicly available on registry
January 29, 2024
CompletedStudy Start
First participant enrolled
March 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2027
March 30, 2026
March 1, 2026
3 years
January 11, 2024
March 24, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Evoked Compound Action Potentials (ECAPs) as measured by the Evoke SCS System
physiological parameter to be measured = Evoked Compound Action Potentials (ECAPs); measurement tool = Evoke SCS System
through 6-months post-implant
Secondary Outcomes (3)
Change in Visual Analogue Scale (VAS) Pain
through 6-months post-implant
Change in PROMIS-29+2
through 6-months post-implant
Change in PROMIS-10 Global Health
through 6-months post-implant
Study Arms (1)
ECAP-Controlled, Closed-Loop SCS
EXPERIMENTALSpinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude.
Interventions
A spinal cord stimulation (SCS) system that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Lakeside Spine and Pain
Lake Havasu City, Arizona, 86403, United States
Spanish Hills Interventional Pain Specialists
Camarillo, California, 93010, United States
Pain Consultants of San Diego
La Mesa, California, 91942, United States
Pacific Research Institute
Santa Rosa, California, 94104, United States
Boomerang Healthcare
Walnut Creek, California, 94598, United States
DBPS Research
Greenwood Village, Colorado, 80111, United States
Pohlman Pain Associates
Delray Beach, Florida, 33445, United States
Horizon Clinical Research
Jasper, Georgia, 30143, United States
Rockford Pain Center
Rockford, Illinois, 61107, United States
Goodman Campbell Brain and Spine
Carmel, Indiana, 46032, United States
Metro Anesthesia & Pain Management
Des Moines, Iowa, 50317, United States
Restorative Pain Institute
Louisville, Kentucky, 40241, United States
Advanced Pain Institute
Hammond, Louisiana, 70403, United States
Spine and Joint Institute
Glen Burnie, Maryland, 21061, United States
Michigan Pain Specialists
Ann Arbor, Michigan, 48108, United States
Pain Clinic of Michigan
Rochester Hills, Michigan, 48309, United States
Tricity Research Center, LLC
Grand Island, Nebraska, 68803, United States
Reno Tahoe Pain Associates
Reno, Nevada, 89509, United States
Garden State Pain and Orthopedics
Clifton, New Jersey, 07013, United States
Seaside Clinical Research Institute
Wilmington, North Carolina, 28412, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Premier Pain Treatment Institute
Loveland, Ohio, 45140, United States
Carolinas Center for Advanced Management of Pain
Greenville, South Carolina, 29615, United States
Institute of Precision Pain Medicine
Corpus Christi, Texas, 78414, United States
Victoria Pain and Rehabilitation Center
Victoria, Texas, 77904, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2024
First Posted
January 29, 2024
Study Start
March 8, 2024
Primary Completion (Estimated)
February 28, 2027
Study Completion (Estimated)
February 28, 2027
Last Updated
March 30, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share