Analgesic Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) for Central Neuropathic Pain in Multiple Sclerosis
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 66
- 试验地点
- 4
- 主要终点
- Change from baseline in "average pain" score on the brief pain inventory
研究概览
简要总结
This study is designed to evaluate the effect of repetitive Transcranial Magnetic Stimulation (rTMS) in the resolution of chronic pain. Participants will be patients with Multiple Sclerosis suffering from chronic pain of neurological origin.
详细描述
On the one hand, Multiple Sclerosis (MS) is the most frequent chronic disease generating neurological disability in young adults. Among the many types of disabilities associated with MS, chronic pain is very frequent, especially neuropathic pain. This type of pain is often treatment resistant. Moreover, abnormal intra-cortical excitability has been described in MS patients.
On the other hand, repetitive Transcranial Magnetic Stimulation (rTMS) has shown an analgesic effect in various chronic pain conditions (fibromyalgia, post-stroke, peripheral neuropathic pain). Three groups have shown that analgesia was correlated to defective intra-cortical excitability restoration.
The goal of this study is to compare the analgesic effects of two types of primary Motor cortex (M1) rTMS, namely 10Hz and prolonged continuous Theta-Burst Stimulation (pcTBS), with sham stimulation.
Patients will benefit from 1 daily session per day for 5 consecutive days and from a total follow up of 4 weeks. Pain will be assessed each day and several other signs and symptoms will be repeatedly assessed.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •relapsing-remitting Multiple Sclerosis
- •18 to 60 years
- •central neuropathic pain with a DN4 score of 4 or more out of 10
- •average pain of at least 4/10
- •presence of pain at least 4 days per week
- •presence of pain for at least 3 months
- •stable analgesic treatment
排除标准
- •relapse during the previous 30 days
- •contraindication for rTMS
- •peripheral neuropathic pain
- •severe depression
- •epilepsia
- •resting motor threshold above 75%
结局指标
主要结局
Change from baseline in "average pain" score on the brief pain inventory
时间窗: at day 8
Variation of the "Average pain" score on the Brief Pain Inventory between before treatment (on a 7 days period) and day 8.
次要结局
- Intra-cortical excitability evaluated by motor threshold, MEP amplitude, SICI and ICF(at week 3 and 4)
- change from baseline in "average pain" score on the brief pain inventory(at weekk 3 and 4)
- Location of MRI abnormalities(at week 3 and 4)
- Number of participants with adverse events as a measure of safety and tolerability(at day 1)
- change from baseline in specific questionnaires(at day 8, week 3 and 4)