N/A Completed N=231 Treatment

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

Postoperative Pain · Back Pain

Source: ClinicalTrials.gov NCT04319887 ↗

Enrolled (actual)

231

Serious AEs

12.7%

Results posted

Dec 2024

Primary outcomePrimary: Evoked Compound Action Potentials (ECAPs) as Measured by the Evoke SCS System — 1.3 ratio

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Evoked Compound Action Potentials (ECAPs) as Measured by the Evoke SCS System	1.3	—

Eligibility Criteria

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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04319887). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.