Non-invasive Cortical Stimulation for Pharmacoresistant Neuropathic Pain: rTMS Versus tDCS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change from Baseline in Pain at the end of the stimulation week Change from Baseline in Pain at the end of the first post-stimulation week Change from Baseline in Pain at the end of the second post-stimulation week
研究概览
简要总结
The aim of this study is to compare analgesic efficacy of two non invasive techniques based on motor cortex stimulation in neuropathic pain patients. High frequency repetitive transcranial magnetic stimulation (HF-rTMS) of primary motor cortex has been demonstrated to induce an analgesic effect significantly different from placebo; this effect is clinically useful if rTMS sessions are applied daily during five consecutive days. Transcranial direct current stimulation (tDCS) is a new approach of non invasive cortical stimulation but its efficacy in neuropathic pain has been not yet established. The investigators propose to compare the analgesic effect of 5 tDCS sessions applied daily to a similar protocol using HF-rTMS. In parallel to the clinical therapeutic evaluation, functional-MRI will be performed before and after the five sessions of rTMS and tDCS, in order to reveal the potential plasticity induced within motor somatotopic map of the primary motor cortex.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged from 18 to 80 years, male or female, fully informed and having given their written consent
- •pharmacoresistant neuropathic pain during at least one year, without any change of the pharmacological treatment since at least one month
排除标准
- •drug addiction, headache, epilepsy history
- •ferromagnetic intracranial device
- •implanted stimulator
- •absence of contraceptive method for women of childbearing age
研究组 & 干预措施
rTMS; tDCS
干预措施: Repetitive Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation (Device)
结局指标
主要结局
Change from Baseline in Pain at the end of the stimulation week Change from Baseline in Pain at the end of the first post-stimulation week Change from Baseline in Pain at the end of the second post-stimulation week
时间窗: Here the Time Frames : Baseline; 1 week; 2 week; 3 week
次要结局
- subjective evaluation of sleep quality using a numerical auto-evaluation scale(Change from Baseline in level of tiredness at the end of the stimulation week;at the end of the first post-stimulation week; and at the end of the second post-stimulation week)
- nociceptive and non-nociceptive thresholds(Change from Baseline in nociceptive threshold after the first day of stimulation;after the fifth day of stimulation;Change from Baseline in non-nociceptive threshold after the first day of stimulation;and after the fifth day of stimulation)
- evaluation of motor cortex plasticity(Change from Baseline in three-dimensional location of the activation peaks at the end of the stimulation week)
- objective evaluation of sleep quality(Change from Baseline in percentage of sleep time at the end of the stimulation week; at the end of the first post-stimulation week; and at the end of the of the second post-stimulation week)