ACTIVE_NOT_RECRUITING

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

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Conditions

Chronic Pain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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.

Quick Facts

Study Start:2024-03-08
Study Completion:2027-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06229470

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Leg pain score ≥ 6 cm (Visual Analog Scale \[VAS\]).
  3. * Back pain score ≥ 6 cm (VAS).
  4. * 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.
  5. * Subject is not pregnant and not \<18 years of age.
  1. * N/A

Contacts and Locations

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Saluda Medical Pty Ltd

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-08
Study Completion Date2027-02-28

Study Record Updates

Study Start Date2024-03-08
Study Completion Date2027-02-28

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Pain