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

N/AActive Not RecruitingNCT06229470

Saluda Medical Pty Ltd250 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

250

Conditions

Chronic Pain

Interventions

Evoke Spinal Cord Stimulation (SCS) SystemDEVICE

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (25)

Lakeside Spine and Pain

Outcomes

Primary Outcomes

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

Time frame: through 6-months post-implant

Secondary Outcomes

Change in Visual Analogue Scale (VAS) Pain

Visual Analogue Scale (VAS) to rate pain intensity (0mm \[no pain\] to 100mm \[worst pain imaginable\])

Time frame: 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.

Time frame: through 6-months post-implant

Change in PROMIS-10 Global Health

10-item instrument that assesses Physical Health and Mental Health

Time frame: through 6-months post-implant

Data from ClinicalTrials.gov

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