Feasibility and Therapeutic Efficacy Study of Medtronic's DTM-Closed-Loop Integrated SCS Technology for Managing Diabetic Peripheral Neuropathic Pain (DPN)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change in Pain Intensity on the Visual Analog Scale (VAS, 0-10) from Baseline to 12 Months
研究概览
简要总结
This study is conducted to evaluate a new way of using spinal cord stimulation (SCS) in people with painful diabetic peripheral neuropathy (DPN). The device used is the Medtronic Inceptiv SCS, which is already approved by the U.S. FDA for treatment of chronic pain. In this study, the system will be programmed to deliver Differential Target Multiplexed (DTM) stimulation with closed-loop feedback using signals from the spinal cord (ECAPs). Up to 25 participants will take part in the study, beginning with a short trial phase and continuing to a permanent implant if the trial is successful. Participants will be followed for 12 months after implant. The main goal is to see whether this therapy can safely and effectively reduce pain in people with diabetic neuropathy. Other measures include physical function, symptom profiles, treatment satisfaction, and monitoring for any side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Adults ≥19 years.
- •Confirmed DPN with EMG evidence of peripheral nerve dysfunction.
- •Persistent lower-limb neuropathic pain VAS ≥6 for ≥6 months despite prior pharmacologic therapy.
- •HbA1c ≤8.5% within 3 months prior to enrollment.
- •No prior SCS/neuromodulation therapy; medically eligible for paddle lead implantation with Inceptiv IPG.
- •Insurance approval or financial ability to cover SCS therapy; able to consent and comply.
排除标准
- •(a) Non-diabetic neuropathies other conditions contributing to lower-limb pain. (b) Contraindications to surgical implantation.
- •(c) History of neurostimulation therapy; active substance abuse or uncontrolled psychiatric illness.
- •(d) Pregnancy or plans for pregnancy; known allergy to device materials; inability to provide informed consent.
结局指标
主要结局
Change in Pain Intensity on the Visual Analog Scale (VAS, 0-10) from Baseline to 12 Months
时间窗: Baseline; End of Trial (~7 days after trial lead placement); 1, 3, 6, and 12 months after permanent implant. Primary time point: 12 months.
Pain intensity is assessed with a 0-10 VAS. Scores are collected at each study visit. The primary endpoint is the change score calculated as 12-month VAS minus baseline VAS; negative values indicate improvement (decrease in pain). Analysis will summarize mean change (SD) and 95% CIs. Additional summaries may include the proportion of participants achieving ≥30% and ≥50% reduction as supportive endpoints.
次要结局
未报告次要终点