Closed Loop Spinal Cord Stimulation for Chemotherapy Induced Peripheral Neuropathy, a Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Numerical Rating Scale (NRS)
研究概览
简要总结
To explore the benefits of using closed loop spinal cord stimulation (SCS) in the treatment of patients experiencing painful chemotherapy induced peripheral neuropathy (CIPN) by assessing changes in pain, quality of life, pain medication use, sensory improvement through quantitative sensory testing, and improvement of gait through quantitative gait testing.
详细描述
Primary Objective:
To explore the impact of using closed loop spinal cord stimulation (SCS) on pain control, quality of life, and pain medication use in patients suffering from chemotherapy induced peripheral neuropathy (CIPN).
Secondary Objective:
To assess the relationship between pain control from closed loop spinal cord stimulation and any associated changes in quantitative sensory testing (QST) and quantitative gait testing (QGT).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Diagnosis history of CIPN of lower extremities
- •Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of SCS
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients undergoing active chemotherapy or immunotherapy
- •Patients undergoing medical litigation.
- •Patients with active infection, being treated with antibiotics
- •Patients that are pregnant or planning to conceive
- •Patients who are receiving any investigational agents.
- •Patients with brain metastases.
- •Patients with cognitive impairment/psychiatric illness/social situations that would limit compliance with study requirements.
- •Patients with history of alternative forms of sensorimotor neuropathies prior to CIPN presentation
研究组 & 干预措施
SCS Implantation
Participants will be screened on a weekly basis in the Pain Management Clinic
干预措施: Spinal cord stimulator implant (Device)
结局指标
主要结局
Numerical Rating Scale (NRS)
时间窗: Through study completion; an average of 1 year
These scales are 0-10 (0 being no pain \& 10 most extreme pain).
次要结局
未报告次要终点