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

A Prospective, Multicenter, Single-arm Study Examining ECAP-controlled, Closed-loop Stimulation With the Evoke Spinal Cord Stimulator (SCS) System to Treat Patients With Chronic Pain of the Trunk and/or Limbs

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.

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).