Transcranial Direct Current Stimulation (tDCS) for Neuropathic Chronic Pain : Study of the Opercular-insular Cortex Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- In healthy subjects : Change in subjective pain and (when applicable) in cortical evoked potentials with pain scale
研究概览
简要总结
The aim of this study is to evaluate, versus placebo, the analgesic efficacy of the opercular-insular cortex stimulation with Transcranial Direct Current Stimulation (tDCS), in both healthy subjects and chronic neuropathic pain patients. In healthy subjects analgesia by tDCS will be assessed using both laser stimuli and cold pressor test. In patients the assessment regards their chronic pain (ratings for ongoing, evoked and paroxysmal pain, sleep and fatigue). Opercular-insular stimulation is obtained via a combined 6-electrode montage and by bi-vestibular stimulation (since vestibular pathways reach the posterior insular cortex). In patients, three separate conditions (two active and one sham) will be tested in randomised order. In healthy subjects, two other conditions are added to control for attention and distraction confounders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- 是
入选标准
- •healthy subjects aged from 18 to 70 years, male or female, with social security protection, fully informed and having given their written consent.
- •patients aged from 18 to 80 years, male or female, with social security protection , 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
- •In healthy subjects only:
- •history of chronic pain
- •analgesic medication within 24h before stimulation
- •For patients only: new analgesic treatment within 1 month before consent
- •drug addiction, headache, epilepsy
- •ferromagnetic intracranial device
- •implanted stimulator
- •recent neurosurgery and open wound of the scalp.
- •absence of contraceptive method for women of childbearing age
结局指标
主要结局
In healthy subjects : Change in subjective pain and (when applicable) in cortical evoked potentials with pain scale
时间窗: just before the tDCS session at Day 0
In patients : Changes in daily ratings of global pain
时间窗: at week 1
In healthy subjects : Change in subjective pain and (when applicable) in cortical evoked potentials
时间窗: just after the tDCS session at Day 0
次要结局
- ongoing pain with pain scale(just after the tDCS session at Day 0)
- ongoing pain as assessed by daily ratings(during one week)