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.

Saluda Medical Pty Ltd50 sites in 1 country250 target enrollmentMarch 8, 2024

ConditionsChronic Pain

Overview

Phase: N/A
Intervention: Not specified
Conditions: Chronic Pain
Sponsor: Saluda Medical Pty Ltd
Enrollment: 250
Locations: 50
Primary Endpoint: Change in Evoked Compound Action Potentials (ECAPs) as measured by the Evoke SCS System
Status: Active, Not Recruiting
Last Updated: last month

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 8, 2024

End Date

February 28, 2027

Last Updated

last month

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Saluda Medical Pty Ltd

Responsible Party

Sponsor

Eligibility Criteria

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.