NCT06121232进行中（未招募）不适用
Exploring the Benefit of Neuromodulation in Treating Chemo-induced Peripheral Neuropathy Using Peripheral Neuropathy Markers (Meissner's Corpuscles and Epidermal Nerve Fiber Density) and Sensory Testing (Quantitative Sensory and Gait Testing): A Single Center Feasibility Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
研究概览
简要总结
To learn if a process called neuromodulation can help to improve pain due to CIP
详细描述
Inclusion Criteria:
- Ability to understand and the willingness to sign a written informed consent document
- Patients diagnosed with CIPN lower extremity due to either vinca alkaloids, taxanes, bortezomib, thalidomide, platinum-based compounds
- Patients seen at Pain Management Center at MD Anderson Cancer Center
- Patient ages greater or equal to 18 years but less than or equal to 85 years
Exclusion Criteria:
- Patients with cognitive dysfunction
- Patient with recent history (<6 months) of drug or alcohol abuse
- Patients with open skin lesion or undergoing antibiotic therapy for local for systemic infection
- Patients with painful diabetic peripheral neuropathy or preexisting peripheral neuropathy
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Ability to understand and the willingness to sign a written informed consent document
- •Patients diagnosed with CIPN lower extremity due to either vinca alkaloids, taxanes, bortezomib, thalidomide, platinum-based compounds
- •Patients seen at Pain Management Center at MD Anderson Cancer Center
- •Patient ages greater or equal to 18 years but less than or equal to 85 years
排除标准
- •Patients with cognitive dysfunction
- •Patient with recent history (<6 months) of drug or alcohol abuse
- •Patients with open skin lesion or undergoing antibiotic therapy for local for systemic infection
- •Patients with painful diabetic peripheral neuropathy or preexisting peripheral neuropathy
研究组 & 干预措施
Treatment Group
Experimental
Group 1 will receive neuromodulation.
干预措施: Abbott® DRG / Abbott®/Medtronic® SCS (Device)
Control Group
Experimental
Group 2 will not receive neuromodulation.
干预措施: Control Group (Other)
结局指标
主要结局
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
时间窗: through study completion; an average of 1 year.
次要结局
未报告次要终点
研究者
研究点 (2)
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