The UPGRADE Study: Real World Outcomes® of Differential Target Multiplexed (DTM-SCS®) Stimulation in Existing and New Medtronic Implants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 255
- 试验地点
- 33
- 主要终点
- To evaluate the Pain Impact Score as measured by the PROMIS-29 before and after introduction of Differential Target Multiplexed (DTM®) stimulation programming in a real-world population.
研究概览
简要总结
The UPGRADE registry will capture long-term, real-world outcomes to understand the effect of Differential Target Multiplexed (DTM®) programming in the Spinal Cord Stimulation (SCS) implanted population on the management of chronic pain, primarily on its use for trunk and/or limb pain. The clinical study is sponsored by Celéri Health and is funded through a financial grant from Medtronic's External Research Program. The registry study will be conducted across approximately 25 centers in the United States with up to 600 participants enrolled.
详细描述
This clinical investigation is a prospective, observational, open-label, non-randomized, multi-center study. It is designed to collect clinical follow-up data on Differential Target Multiplexed (DTM®) programming that is available in Medtronic's Intellis™ and Vanta™ spinal cord stimulators, which has shown superiority to conventional programming parameters in a randomized controlled trial (NCT03606187).
Participants currently implanted with a permanent neurostimulation system, whom are planned for conversion to DTM® programming as well as newly identified participants planned to undergo a trial of neurostimulation using DTM® will be eligible to participate in this study. Data will be collected at baseline prior to DTM® programming exposure.
Participants who continue to meet eligibility criteria and have had their implanted DTM programming activated will enter a follow-up period for up to 24 months, where participant self-reported questionnaires will be assessed each month with study visits to occur at months 12 and 24.
Throughout the study, objective functional data will be collected automatically as part of the Medtronic device interrogation.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must provide written informed consent prior to any clinical study-related procedure.
- •Participant is at least 18 years (or the minimum age required by local law to consent for participation in a clinical investigation) or older at the time of enrollment.
- •Participant has a permanent Medtronic Intellis™ neurostimulation system implanted or is planning to be implanted with a Medtronic Intellis™ or Vanta™ neurostimulation system.
- •Participant has access to an iPhone or Android capable device and/or computer with regular internet access for the purposes of electronically completing web-based participant self-reported questionnaires via SMS text or email.
排除标准
- •Participant is unable to provide written informed consent or to comply with study-related requirements, procedures, and visits.
- •Participant is a profound responder for all pain areas to existing neurostimulation therapy (≥80% reported relief).
- •Participant is enrolled, or intends to participate, in a clinical drug and/or device study (investigational device, investigational drug, new indication for a device or drug, or additional testing beyond standard of care procedures) which could confound the results of this trial as determined by the investigator.
- •Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the participant's ability to participate in the clinical investigation or to comply with follow-up requirements.
- •Participant is pregnant or nursing.
结局指标
主要结局
To evaluate the Pain Impact Score as measured by the PROMIS-29 before and after introduction of Differential Target Multiplexed (DTM®) stimulation programming in a real-world population.
时间窗: 24 months
次要结局
- To characterize the responder rate for pain by pain area per Percent Pain Relief for DTM-SCS® compared to participant baseline treatment.(24 months)
- To characterize the neuropathic pain quality using PROMIS-Neuropathic Pain Quality (PROMIS-PQ-Neuro) before and after treatment.(24 months)
- To characterize the responder rate for pain by pain area per Numeric Rating Scale for DTM-SCS® compared to participant baseline treatment.(24 months)
- To evaluate the longitudinal characterization of objective posture and activity measures.(24 months)
- To characterize Patient Global Impression of Change (PGIC) with neurostimulation.(24 months)
- To evaluate the performance of the DTM® pre-programming questionnaire in predicting outcome of DTM-SCS® programming.(24 months)