Assessment of Effectiveness of Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy on Pain Reduction and Improvement of Quality of Life in Patients With Chemotherapy Induced Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 5
- 主要终点
- Overall pain intensity
研究概览
简要总结
The goal of this observational study is to learn about the effectiveness of closed-loop spinal cord stimulation (CL-SCS) therapy for treatment of painful chemotherapy induced peripheral neuropathy.
The closed-loop SCS (CL-SCS) system stimulates the nerves in the spinal cord, measures their responses and automatically adjust the stimulation level accordingly in real time for each delivered pulse.
详细描述
Chemotherapy induced peripheral neuropathy (CIPN) is a serious condition that is diagnosed in up to 40% of patients who require chemotherapy. Conventional treatments for painful CIPN include both pharmacological and non-pharmacological interventions, although the underlying evidence is scarce. Spinal cord stimulation is an established treatment for pain associated with painful peripheral neuropathies. Several studies demonstrate pain relief by open-loop spinal cord stimulation (SCS) in patients with painful CIPN, with a positive effect of SCS on pain and quality of life. In the Netherlands, CIPN is an accepted indication for SCS treatment and thus SCS is a regular treatment for patients with painful and refractory CIPN. The closed-loop SCS (CL-SCS) system stimulates the dorsal column in the spinal cord, measures the response through evoked compound action potentials (ECAPs), and automatically adjust the stimulation level accordingly in real time for each delivered pulse.
The current study aims to evaluate the effectiveness of closed-loop spinal cord stimulation (CL-SCS) therapy in patients with CIPN.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 未提供
排除标准
- •Patient refusal to be included in study
- •Patients unwilling or mentally incapable to complete the study questionnaires
- •Other causes of neuropathy (for example diabetic- or small fiber neuropathy)
- •Previous treatment with SCS for CIPN
- •Presence of another pain syndrome unrelated to CIPN
- •History of lower limb amputation or ulceration
- •Body mass index (BMI) ≥ 40
- •Severe psychiatric or neurological disorders
- •Any other contra indication for locoregional anaesthesia
结局指标
主要结局
Overall pain intensity
时间窗: The difference between baseline and the evaluation at 1, 3, 6 and 12 months after SCS implantation.
The primary effectiveness outcome measure is pain intensity measured with the Numeric Rating Scale (NRS; 0 no pain, 10 worst imaginable pain) at 1, 3, 6 and 12 months after SCS implantation.
次要结局
- Pain intensity for the extremities (arms and/or legs)(The difference between baseline and the evaluation at 1, 3, 6 and 12 months after SCS implantation.)
- 9-Item Patient-Reported Outcomes Measurement Information System (PROMIS-29)(The difference between baseline and the evaluation 1, 3, 6 and 12 months after SCS implantation.)
- Medication use(The change between baseline and the evaluation 1, 3, 6 and 12 months after treatment with closed-loop SCS)
- SCS stimulation pulse width(Evaluation at 1, 3, 6 and 12 months after SCS implantation.)
- SCS stimulation frequency(Evaluation at 1, 3, 6 and 12 months after SCS implantation.)
- (Serious) adverse events(Evaluation at 1, 3, 6 and 12 months after SCS implantation)
- Patient Global Impression of Change (PGIC)(The change between baseline and the evaluation 1, 3, 6 and 12 months after SCS implantation.)
- CIPN-related symptoms(The change between baseline and the evaluation 1, 3, 6 and 12 months after SCS implantation.)
- Stimulation coverage and patient stimulation awareness and satisfaction(Evaluation at 1, 3, 6 and 12 months after SCS implantation)