Exploring the Benefit of Peripheral Nerve Stimulation in Treating Pain From Chemo-induced Peripheral Neuropathy: A Longitudinal Single Center Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Safety and adverse events (AEs)
研究概览
简要总结
To learn if peripheral nerve stimulation (PNS) can help to improve pain in participants with CIPN.
详细描述
Primary objective:
To assess Pain intensity (NRS) scores in chemotherapy induced peripheral neuropathy (CIPN) participants before and after use of peripheral nerve stimulation (PNS).
Secondary objectives:
To assess changes in quantitative sensory testing (QST), gait testing, and skin punch biopsy to compare the integrity of Meissner's corpuscles (MC), pain disability using the Oswestry Disability Index (ODI), pain interference using the Brief Pain Inventory (BPI), and Patient Global Impression of Change (PGIC) in CIPN patients before and after use of PNS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants diagnosed with chronic (≥90 days duration) CIPN (due to either vinca alkaloids, taxanes, bortezomib, thalidomide, platinum-based compounds or ionizing irradiation) of the lower extremity, seen at Pain Management Center at MD Anderson Cancer Center
- •Participants reports baseline pain ≥ 4 (0-10 scale, NRS)
- •Participants between ages 18-85 years old
- •Participants who have completed chemotherapy within the previous year at the time of enrollment
排除标准
- •Participants with cognitive dysfunction
- •Participants with recent history (<6 months) of drug or alcohol abuse
- •Participants with open skin lesion or undergoing antibiotic therapy for local for systemic infection
- •Participants with allergies to local anesthesia, steroids, or adhesives
- •Participants with conditions that conflict with the SPRINT PNS System Indications for Use, including Contraindications and Warnings.
研究组 & 干预措施
Peripheral Nerve Stimulation
Participants will be asked to have PNS leads inserted via a needle, which will provide a mild, stimulating electrical current to the effected nerves 24 hours a day for up to 60 days. Participants will have study visits during and after this time.
干预措施: Peripheral Nerve Stimulation (Other)
结局指标
主要结局
Safety and adverse events (AEs)
时间窗: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
次要结局
未报告次要终点