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

Saluda Medical

Status: Enrolling

Conditions: Chronic Pain

Treatments: Device: Evoke Spinal Cord Stimulation (SCS) System

Study type: Interventional

Funder types: Industry

Identifiers

NCT06229470

D103977

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

ECAP-Controlled, Closed-Loop SCS

Experimental group

Description:

Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude.

Treatment:

Device: Evoke Spinal Cord Stimulation (SCS) System