Long-term Efficacy of Repetitive Transcranial Magnetic Stimulation on the Primary Motor Cortex (M1) in Central Neuropathic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Percentage of pain relief (0%= " no pain relief " and 100% " complete pain relief ")
研究概览
简要总结
The repetitive transcranial magnetic stimulation (rTMS) is used in pain treatment for several years. The aim of the study is to assess, in a rigorous scientific protocol, analgesic effect of the neuronavigated rTMS assisted by robotic arm on chronic neuropathic painful subjects. The crossover study is randomized, double blinded and controlled (sham rTMS) and it includes a large homogeneous population suffering of central neuropathic pain.
详细描述
The repetitive transcranial magnetic stimulation (rTMS) is used in pain treatment for several years. The latest meta-analysis showed that rTMS has not prove its scientific efficacy. It could be explained by several reasons: poor methodologic quality, stimulations parameters, technologic hardware, ... The aim of the study is to assess, in a rigorous scientific protocol, analgesic effect of the neuronavigated rTMS assisted by robotic arm on chronic neuropathic painful subjects. The crossover study is randomized, double blinded and controlled (sham rTMS) and it includes a large homogeneous population suffering of central neuropathic pain. The stimulated region is the primary motor cortex with high frequency (20Hz). This study has two periods (real and sham) of 12 weeks with four sessions of stimulation per period and 8 weeks of washout between the two.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Central neuropathic pain
- •Chronic pain with an average pain intensity is greater than or equal to 40/100
- •Pain presents a daily or almost daily (at least 4 days out of 7)
- •Pain presents for more than 6 months
- •Patients who signed informed consent,
- •Patients whose pain medication is stable for 15 days before to inclusion, and will not need to be modified for the duration of the study,
- •Patients can be monitored for the duration of the study (29 weeks)
- •Patients affiliated to a health insurance plan or entitled,
- •Patients with a cerebral MRI T1.
排除标准
- •Labor dispute or Accident,
- •Contraindication to rTMS (treatment with electroconvulsive therapy during the previous month, epilepsy and / or a history of epilepsy, history of head trauma, neurosurgical injury; intracranial hypertension metal clip; pacemaker pregnant or lactating women)
- •Abuse of drugs or psychoactive substances
- •Peripheral Neuropathic Pain,
- •Neuropathic pain within the framework of a progressive disease (HIV, cancer, non-stabilized system disease)
- •Intermittent pain,
- •Pain in less than 6 months,
- •Presence of other pain more severe than that justify inclusion,
- •Lack of stability pain scores on two successive evaluations, defined as a change of more than 30% between the two assessments of the average pain between the first two visits (inclusion and first session)
- •Patients unable to understand informed consent, under guardianship,
- •Patients refusing to stop or can not stop the prohibited treatment during the study,
- •Patients participating in another research protocol involving a drug within 30 days before inclusion.
结局指标
主要结局
Percentage of pain relief (0%= " no pain relief " and 100% " complete pain relief ")
时间窗: 3 weeks later the last session of rTMS (active ) so week n°12
Percentage of pain relief compared to the beginning of the period of the study before the first stimulation
Percentage of pain relief (0%= " no pain relief " and 100% " complete pain
时间窗: 3 weeks later the last session of rTMS (sham) so week n°29.
Percentage of pain relief compared to the beginning of the period of the study before the first stimulation
次要结局
- Neuropathic dimension(at each session (or weeks number: 0, 3, 6, 9, 12 and 17, 20, 23, 26, 29))
- - Percentage of responders to the treatment real rTMS: subjects whom the Percentage of pain relief at the end of each period of 4 sessions (weeks n°12 and 29) is at least 15%.(at the end of each period of 4 sessions (weeks n°12 and 29))
- Intensity of " average pain " assess by a visual analogue scale (VAS) of 100 mm (0= " no pain " and 100= " worst pain imaginable ").(3 weeks after the last sessions of rTMS (real or sham), so week n°12 and n°29.)
- Intensity of " average pain " with VAS before each session compared to the previous meeting (or weeks number: 3, 6, 9, 12 and 20, 23, 26, 29)(before each session (or weeks number: 3, 6, 9, 12 and 20, 23, 26, 29))
- Percentage relief of pain before each session compared to the previous meeting (or weeks number: 3, 6, 9, 12 and 20, 23, 26, 29)(before each session (or weeks number: 3, 6, 9, 12 and 20, 23, 26, 29))
- Consumption of analgesic treatment(3 weeks before the first session of the period and week : 3, 6, 9, 12 and 20, 23, 26, 29)