Wayville

Researchers are evaluating VIA Disc NP, a minimally processed human nucleus pulposus tissue allograft, as a supplement for degenerated intervertebral discs in participants with symptomatic lumbar disc degeneration lasting more than 6 months and unresponsive to at least 3 months of conservative treatment. This Phase 2 randomized, double-blind, sham-controlled, multi-center study aims to assess the safety and effectiveness of VIA Disc NP compared to a sham procedure. Participants will be randomly assigned in a 1:1 ratio to receive either a single intradiscal injection of 100 mg of VIA Disc NP mixed with sterile saline at one or two affected levels (L1-S1) or a sham procedure where a needle is inserted through the skin and muscle but does not penetrate the disc annulus. The treatment is delivered once, targeting 1 or 2 lumbar disc levels. During the study, participants will be monitored for treatment effectiveness and safety up to 26 weeks. Effectiveness is measured by the proportion achieving a meaningful improvement in pain scores from baseline to 26 weeks, and safety by reported treatment-related adverse events up to 12 weeks. Assessments include pain severity (VAS), disability scores (ODI), neurologic exams, and patient-reported outcomes. The total participation age range is 22 to 85 years old.

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.

Researchers are evaluating the ShiraTronics Migraine Therapy System in a pilot study to assess its preliminary safety and effectiveness in preventing chronic migraines for patients who have not responded well to other treatments. The study focuses on adults aged 22 years and older who experience frequent headaches and have a history of migraines lasting at least one year. This research aims to provide new options for those with refractory chronic migraine who have limited success with existing therapies. Participants will use the ShiraTronics Migraine Therapy System, a neurostimulator device designed to relieve, interrupt, and prevent chronic migraine attacks. The study does not specify multiple groups or comparators but emphasizes the evaluation of this device’s impact on migraine symptoms over a set period. The treatment will be monitored closely for safety and efficacy throughout the study. During the study, participants will be assessed based on the number of headache days they experience during 12 weeks of treatment. Researchers will track migraine frequency, safety outcomes, and overall response to the neurostimulator. Participants must maintain stable use of any migraine medication they are currently taking and will be monitored for any changes or side effects. The total duration and detailed procedures beyond the primary outcome measure are not specified but focus on observing the device’s effect on chronic migraine frequency and patient safety.

Researchers are evaluating whether Ultra Low Frequency (ULF) neuromodulation can help treat adults with chronic, difficult-to-treat nociceptive low back pain. This study also aims to determine the safety of ULF therapy compared to conventional medical treatments over a 24-month period. Participants have persistent back pain that has not responded well to other treatments, and the trial will explore if ULF therapy reduces pain and if any unexpected medical issues arise during treatment. Participants are randomly assigned in a 2:1 ratio to receive either ULF therapy combined with conventional medical management or conventional medical management alone. Those assigned to ULF therapy will undergo a temporary trial phase and may receive a permanent device implant if they experience at least 50% pain relief. At six months, participants who meet certain criteria can switch to the other treatment group. The primary goal is to assess back pain improvement after three months, with ongoing follow-up for two years. During the study, participants will attend regular clinic visits for checkups and data collection. Researchers will monitor pain levels using standard measures, including the back pain visual analog scale (VAS) responder rate at three months. Safety and effectiveness will be tracked throughout the 24-month study period, and participants will complete questionnaires and other assessments to evaluate their progress and treatment impact.