Novel Treatment Delivery of ECAP-controlled Closed-loop SCS for Chronic Pain (Freshwater)

Saluda Medical

Status: Enrolling

Conditions: Chronic Pain

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04662905

CLIN-PCL-007873

Details and patient eligibility

About

The purpose of this study is to test and evaluate novel treatment delivery of ECAP-controlled closed loop SCS through the incorporation of new software and/or hardware features for patients with the Evoke System.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Subject has undergone trial implant or is planning to be implanted with the Evoke System within its approved indication.
• 2. Subject is willing and capable of giving informed consent and able to comply with study-related requirements.

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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200 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