Noosa Heads

Researchers are evaluating a new method of delivering Evoke Compound Action Potentials (ECAP)-controlled closed-loop spinal cord stimulation (SCS) using updated software and/or hardware features for people living with chronic pain in the trunk and/or limbs. This feasibility study aims to test and assess the novel treatment delivery with the Evoke SCS System to better understand its potential use for managing chronic pain. Participants will receive the Evoke Spinal Cord Stimulation System, which is a device that provides ECAP-controlled, closed-loop spinal cord stimulation. The study is single-arm and multicenter, focusing on patients who have already undergone or are planning to undergo implantation of the Evoke System within its approved use. The study does not include a comparison group. During the study, researchers will monitor changes in Evoke Compound Action Potentials (ECAPs) using the Evoke SCS System. Participants will be followed for up to two years to assess this primary outcome. Throughout participation, individuals will be asked to comply with study requirements and provide informed consent, with ongoing evaluation to understand the treatment's impact on chronic pain.

This research evaluates anonymous, previously collected medical data to review the outcomes of different treatment methods for chronic pain. The study is a retrospective review involving multiple centers and independent patient groups to compare results across various subgroups. The study examines clinical outcomes related to the use of spinal cord stimulation, radiofrequency (RF), and other implantable device systems from Boston Scientific and other manufacturers. Multiple cohorts will be analyzed based on the type of treatment system used. Participants' medical charts will be reviewed to measure response rates through approximately two years of follow-up. The study focuses on clinical results documented in patient records without any new treatment or intervention administered during the study.

Researchers are conducting a global, multi-center, prospective post-market study to observe the long-term effectiveness of Boston Scientific neurostimulation systems in managing pain. The study aims to gather real-world clinical outcomes, economic value, and technical performance data of these commercially approved neurostimulation devices when used in routine clinical practice. The treatment involves an initial trial period using a Boston Scientific neurostimulation device for pain relief. Participants who experience a positive response during the trial may proceed to receive a permanent implant of the neurostimulation system. The therapy is tailored individually based on the investigator's judgment and standard care practices at each study site, following specific inclusion and exclusion criteria. Participants will be monitored throughout the trial and permanent implant phases to assess pain relief and overall treatment effectiveness. Assessments may include patient evaluations of pain and ability to complete study requirements. The study focuses on capturing comprehensive data to evaluate both clinical outcomes and device performance during regular use. Total participation duration depends on individual treatment progression from trial to permanent implant.