Clinical Study Protocol Dorsal Root Ganglion Stimulation for the Management of Painful Intractable Small Fibre Neuropathy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Change in pain intensity assessed by Numeric Rating Scale.
研究概览
简要总结
A prospective, single-arm, mono-centre pilot study to obtain preliminary information on the ability of Dorsal Root Ganglion Stimulation (DRGS) in alleviating the painful symptoms in patients with small fiber neuropathy (SFN).
详细描述
This study is a prospective, single-arm, mono-centre pilot study enrolling a maximum of 31 patients with SFN. All enrolled patients will receive a trial neurostimulation (TNS) lasting from 3 to 30 days and only patients with a positive result in terms of pain intensity reduction will be eligible for the implanted neurostimulation (INS) phase. The target number of patients eligible for INS is 10 and this population will be assessed for impact of DRGS on the neuropathic pain caused by SFN. The expected duration of patients participation will be 14 months. The rationale for this open label approach is that this is a novel technique for which pilot data with regard to applicability and efficacy have yet to be established. Data gathered in the study will provide preliminary data required to assess the feasibility of this intervention, to be used for possible future studies with a more rigorous methodological approach (i.e. controlled trial, randomized controlled trial).
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
- •18 years or older at inclusion
- •Chronic, intractable painful SFN in the peripheral limbs during at least 12 months and a biopsy positive for SFN, with a chronic pain intensity of ≥ 6 on a Numeric Rating Scale (ranging from 0 to 10), for which previous drug therapy was unsuccessful
- •Stable medication dosage in the 30 days prior to inclusion
- •Stable pattern of neurological symptoms
排除标准
- •Known or suspected non-compliance
- •Drug or alcohol abuse
- •Pain predominantly in upper limbs
- •Neuropathy or chronic pain in limbs of other origin than SFN
- •Peripheral vascular disease
- •Severe foraminal stenosis at the expected target level
- •Coagulation disorders
- •Known immune-deficiency
- •Other significant concomitant diseases and any concomitant malignancies
- •Presence of other indwelling devices
结局指标
主要结局
Change in pain intensity assessed by Numeric Rating Scale.
时间窗: Pain intensity assessment during 2 weeks after inmplatation, at Time point 6 and 12 months after implantation.
Four assessments/day for 5 consecutive days around the intended measurement timepoint
次要结局
未报告次要终点
研究者
Eva Koetsier MD PhD LLM
MD PhD LLM
Ospedale Regionale di Lugano