Therapeutic Efficacy and Feasibility Study of Abbott's BurstDR Spinal Cord Stimulators Technology for Painful Diabetic Neuropathy (PDN)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- VAS Change Baseline to 6 Month
研究概览
简要总结
This prospective, single-arm clinical study evaluates the therapeutic efficacy and feasibility of BurstDR spinal cord stimulation (SCS) using Abbott's Proclaim XR and Eterna systems in patients with painful diabetic neuropathy (PDN). Adults with confirmed PDN will undergo a one-week temporary SCS trial, and those achieving meaningful improvement (≥50% reduction in average pain on the Visual Analog Scale) will proceed to permanent implantation. Outcomes will be assessed at baseline, end of trial, and at 1-, 3-, and 6-month follow-up visits using validated instruments including VAS, DN4, DQoL, PSQ-3, the Patient Global Impression of Change, and the Clinician Global Impression of Change. All procedures follow standard clinical practice for SCS therapy. The study aims to characterize real-world effectiveness, patient-reported outcomes, feasibility of implementation, and device-related safety in a rural PDN population.
详细描述
This investigator-initiated, post-market clinical study is designed to evaluate the efficacy, feasibility, and safety of BurstDR spinal cord stimulation (SCS) for the management of painful diabetic neuropathy (PDN) using Abbott's Proclaim XR and Eterna implantable pulse generator systems. The SCS systems used in this study are FDA-approved for PDN, and all clinical procedures-including the percutaneous trial phase and permanent implantation-are performed according to standard-of-care practice by experienced clinicians.
Eligible participants are adults aged 19 years or older with confirmed diabetic neuropathy (via EMG or skin biopsy), neuropathic pain severity meeting VAS ≥6 and DN4 ≥4, failure of conventional medical therapy, and suitability for SCS treatment. After informed consent, participants will complete baseline assessments followed by a temporary one-week SCS trial with BurstDR stimulation. Participants who experience meaningful pain reduction during the trial will proceed to permanent implantation. Follow-up assessments occur at 1, 3, and 6 months after implantation, during which validated patient-reported outcomes and clinician-reported measures will be collected. Adverse events, device-related complications, therapy discontinuations, and protocol deviations will be monitored and documented.
The study's primary objective is to determine the proportion of participants achieving ≥50% pain reduction on the Visual Analog Scale at follow-up visits. Secondary objectives evaluate changes in diabetes-related quality of life (DQoL), neuropathic symptoms (DN4), sleep interference (PSQ-3), and patient and clinician impression of change. Tertiary objectives assess feasibility parameters including recruitment rates, retention, protocol adherence, and safety outcomes. Data will be captured and stored using a HIPAA-compliant, 21 CFR Part 11-validated Clinical Trial Management System. The study is conducted at TriCity Research Center with IRB oversight and is funded by Abbott, which has no role in study design, data analysis, or publication decisions.
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
盲法说明
Open-label study. No parties are masked
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
- •Age 19 years or older.
- •Diagnosis of diabetic peripheral neuropathy (DPN) confirmed by nerve conduction study (EMG/NCS) or skin biopsy.
- •Persistent neuropathic pain in the lower extremities for ≥6 months.
- •Average baseline pain score of ≥6 on the Visual Analog Scale (VAS).
- •DN4 score ≥4, indicating neuropathic pain characteristics.
- •Inadequate pain relief with conventional medical therapy, including at least two classes of analgesic or neuropathic pain medications (e.g., gabapentinoids, SNRIs, TCAs, opioids).
- •Candidate for spinal cord stimulation based on clinical evaluation by the treating physician.
- •Able and willing to comply with all trial procedures and follow-up visits.
- •Able to provide written informed consent in English or in an IRB-approved translated language.
排除标准
- •Prior spinal cord stimulator implantation or previous SCS trial that was unsuccessful.
- •Contraindications to SCS placement, including:
- •Active systemic infection or local infection at planned needle entry site
- •Bleeding disorders or inability to temporarily discontinue anticoagulation if required
- •Known allergy to device materials or components
- •Severe uncontrolled medical conditions that increase surgical risk, including:
- •Unstable cardiovascular disease
- •Severe renal or hepatic dysfunction
- •Uncontrolled diabetes (e.g., HbA1c > 10%)
- •Severe or uncontrolled psychiatric illness that, in the investigator's judgment, may interfere with study compliance.
- •Current substance use disorder, including active opioid misuse or illicit drug use, based on clinician assessment.
- •Pregnancy or planning to become pregnant during the study period.
- •Life expectancy less than 12 months.
- •Participation in another interventional clinical trial that may confound results or interfere with study procedures.
- •Any condition that, in the investigator's opinion, makes the participant unsuitable for SCS therapy or the study.
研究组 & 干预措施
Test Group [Burst DR SCS]
Participants receive BurstDR spinal cord stimulation delivered through Abbott Proclaim XR or Eterna systems, beginning with a temporary trial followed by permanent implantation for responders.
干预措施: BurstDR Spinal Cord Stimulation (Device)
结局指标
主要结局
VAS Change Baseline to 6 Month
时间窗: 1 month, 3 months, and 6 months
Pain will be assessed using the Visual Analog Scale (VAS). The primary endpoint is the proportion of participants who achieve at least a 50% reduction in average VAS pain score from baseline to each follow-up visit after permanent implantation.
次要结局
- Change in DN4 neuropathic pain score(1 month, 3 months, and 6 months after permanent implantation)
- Change in pain-related sleep interference (PSQ-3)(1 month, 3 months, and 6 months after permanent implantation)
- Diabetes QoL Change Baseline to 6 Months(1 month, 3 months, and 6 months after permanent implantation)