Non-invasive Analgesic Stimulation of the Motor Cortex at Home
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Fatigue : numerical rating scale (NRS) from 0 (exhausted) to 10 (very well)
研究概览
简要总结
The purpose of this study is to confirm the analgesic effect of tDCS in neuropathic chronic pain, to estimate the importance and the duration of this effect, and to improve its efficiency by the use at home.
It is established that the repetition of the sessions of cortical stimulation over a week improves their analgesic efficacy. However, this effect does not exceed a few weeks and is much lower than that of the stimulation implanted surgically. Implanted stimulation operates periodically, several times a day, and this "repetition of doses ", akin to the regular taking of a medicine, may explain its longer efficacy for pain relief which, may extend over several years (André-Obadia and al 2014).
No study at this date has estimated the long-term effect of non-invasive stimulation when is also periodically repeated on a daily basis, over several weeks.
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
- Single (Participant)
盲法说明
Efficacy will be assessed in a single-blind trial, with each patient receiving a series of "placebo" stimulations to check the clinical reality of the effects on pain.
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 from 18 to 80 years old, men or women, suffering pharmaco-resistant neuropathic chronic pain for more than one year; NVS > 2 during the week S0) unilateral pharmacoresistant, whose analgesic treatment is stable for at least 1 month.
- •Patients whose pharmacoresistance leads their referent doctor to consider non-pharmacological therapeutic alternatives and begin a presurgical assessment.
- •Patients having an operational Internet connection. The patient or one person of its circle of acquaintances will have to be able to connect on the Internet and to reach by this way the system of relocated stimulation ("The Cloud").
- •Patients having shown pain relief to a single- or whole-week sessions of tDCS are not excluded from potential recruitment for this study.
- •Patients having a social security cover.
- •Patients having given their written consent.
排除标准
- •of addiction to drugs,
- •of epilepsy.
- •Présence of an intra-cranial ferromagnetic equipment or of an implanted stimulation device (e.g. stimulating, central grey pacemaker, stimulation of the basal ganglia or of the vagus nerve).
- •Introduction of a new analgesic treatment for less than a month.
- •Lack of a effective contraception for all the duration of the study for the patients old enough to procreate.
- •(No limitation in the inclusion of male patients old enough to procreate).
- •Patient under legal protective measure.
- •Pregnant women and nursing mothers
研究组 & 干预措施
Patients with neuropathic chronic pain
干预措施: tDCS (use at home) (Device)
结局指标
主要结局
Fatigue : numerical rating scale (NRS) from 0 (exhausted) to 10 (very well)
时间窗: over the week preceding the stimulation (W1), the period of ambulatory stimulation (W2-3-4-5) and the month according to the latter (W6-7-8-9-10)
Quality of sleep : numerical rating scale (NRS) from 0 (no sleep) to 10 (very good sleep).
时间窗: over the week preceding the stimulation (W1), the period of ambulatory stimulation (W2-3-4-5) and the month according to the latter (W6-7-8-9-10)
次要结局
未报告次要终点