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.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Device: Evoke Spinal Cord Stimulation (SCS) System

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Lake Havasu City, Arizona, United States, 86403
      • Lakeside Spine and Pain
  • California
    • Camarillo, California, United States, 93010
      • Spanish Hills Interventional Pain Specialists
    • La Mesa, California, United States, 91942
      • Pain Consultants of San Diego
    • Santa Rosa, California, United States, 94104
      • Pacific Research Institute
    • Walnut Creek, California, United States, 94598
      • Boomerang Healthcare
  • Colorado
    • Greenwood Village, Colorado, United States, 80111
      • DBPS Research
  • Florida
    • Delray Beach, Florida, United States, 33445
      • Pohlman Pain Associates
  • Georgia
    • Jasper, Georgia, United States, 30143
      • Horizon Clinical Research
  • Illinois
    • Rockford, Illinois, United States, 61107
      • Rockford Pain Center
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Goodman Campbell Brain and Spine
  • Iowa
    • Des Moines, Iowa, United States, 50317
      • Metro Anesthesia & Pain Management
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Restorative Pain Institute
  • Louisiana
    • Hammond, Louisiana, United States, 70403
      • Advanced Pain Institute
  • Maryland
    • Glen Burnie, Maryland, United States, 21061
      • Spine and Joint Institute
  • Michigan
    • Ann Arbor, Michigan, United States, 48108
      • Michigan Pain Specialists
    • Rochester Hills, Michigan, United States, 48309
      • Pain Clinic of Michigan
  • Nebraska
    • Grand Island, Nebraska, United States, 68803
      • Tricity Research Center, LLC
  • Nevada
    • Reno, Nevada, United States, 89509
      • Reno Tahoe Pain Associates
  • New Jersey
    • Clifton, New Jersey, United States, 07013
      • Garden State Pain and Orthopedics
  • North Carolina
    • Wilmington, North Carolina, United States, 28412
      • Seaside Clinical Research Institute
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
    • Loveland, Ohio, United States, 45140
      • Premier Pain Treatment Institute
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Carolinas Center for Advanced Management of Pain
  • Texas
    • Corpus Christi, Texas, United States, 78414
      • Institute of Precision Pain Medicine
    • Victoria, Texas, United States, 77904
      • Victoria Pain and Rehabilitation Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• N/A

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ECAP-Controlled, Closed-Loop SCS; Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude.	Device: Evoke Spinal Cord Stimulation (SCS) System; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Visual Analogue Scale (VAS) Pain	Visual Analogue Scale (VAS) to rate pain intensity (0mm [no pain] to 100mm [worst pain imaginable])	through 6-months post-implant
Change in PROMIS-29+2	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.	through 6-months post-implant
Change in PROMIS-10 Global Health	10-item instrument that assesses Physical Health and Mental Health	through 6-months post-implant

Collaborators and Investigators

• Sponsor: Saluda Medical Pty Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2024
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: January 11, 2024
• First Submitted That Met QC Criteria: January 19, 2024
• First Posted (Actual): January 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Therapeutics; Drug Therapy; Physical Therapy Modalities; Rehabilitation; Electric Stimulation Therapy; Drug Delivery Systems; Spinal Cord Stimulation
• Other Study ID Numbers: D103977

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No