ECAP-controlled, Closed-loop Stimulation to Treat Chronic Trunk and/or Limb Pain (ECAP)

Saluda Medical

Status: Completed

Conditions: Back Pain; Chronic Pain; Pain

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04319887

CLIN-PCL-006732

Details and patient eligibility

About

The purpose of this study is to evaluate neurophysiological measures and clinical outcomes of the Evoke System to treat trunk and/or limb pain in a real-world population.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject has chronic intractable pain of the trunk and/or limbs.
• Subject is willing and capable of giving informed consent and able to comply with study-related requirements, procedures, and visits.

Exclusion criteria

• Subject is unable to operate the system.
• Subject is an unsuitable surgical candidate.
• Subject has a condition currently requiring or likely to require the use of diathermy.
• Subject has another implantable stimulator such as demand type pacemakers or cardioverter defibrillator.
• Subject is <18 years old.
• Subject is pregnant or nursing.
• Subject is allergic, or has shown hypersensitivity, to any materials of the neurostimulation system which come in contact with the body.
• Subject is being treated with electroconvulsive therapy (ECT) or transcranial magnetic stimulation (rTMS).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 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