Skip to content

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

CompletedNot applicableNCT04319887
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
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
Sponsor
Saluda Medical Pty Ltd
Start date
2020-10-29
Primary completion
2023-12-28
Sex
All
Age range
from 18 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
22

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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).

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04319887