NCT06250491招募中不适用
Effects of Deep rTMS in Neuropathic Pain or Fibromyalgia : a Bicenter Randomized Sham Controlled Study
Nadine ATTAL4 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年1月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Effects of rTMS versus sham rTMS on pain relief at 13 weeks
研究概览
简要总结
This study will investigate the efficacy and safety of "deep" rTMS on neuropathic pain or fibromyalgia. It will be randomized and sham controlled and will last 3 months. Patients will be randomized to receive acctive rTMS or sham rTMS and will receive repeated rTMS sessions (5 daily sessions then one session per week then every 2 to 3 weeks for up to 10 weeks).
详细描述
This double blind sham controlled parallel group bicenter study will assess the efficacy and safety of repeated sessions of deep rTMS using H coil in patients with neuropathic pain or fibromyalgia. Primary outcome will be % of pain relief at week 13.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- 否
入选标准
- •Chronic pain ≥ 6 months, at least 4/10 on a 0-10 NRS, present every day or nearly every day
- •Neuropathic pain (confirmed with Douleur Neuropathique en 4 questions and international criteria from NeuPSIG) or fibromyalgia (revised ACR criteria)
- •Stable concomitant medications for pain for at least one month
- •Able to fill out questionnaires and understand and speak French
排除标准
- •Contraindications to rTMS
- •Prior treatment with rTMS
- •Progressive severe condition (eg cancer)
- •Psychosis
- •Psychoactive drug abuse
结局指标
主要结局
Effects of rTMS versus sham rTMS on pain relief at 13 weeks
时间窗: 13 weeks
Pain relief scale from the Brief Pain Inventory rated from 0 to 100 %
次要结局
- Self-reported pain intensity(Baseline then every day at the same time of day (morning or evening))
- Effects of rTMS vs sham on pain right now from Brief Pain Inventory(Baseline then each follow up visit at the pain center for up to 13 weeks)
- Effects of rTMS vs sham on average pain intensity(Each follow up visit at the pain center for up to 13 weeks)
- Effects of rTMS vs sham on sleep(Baseline then each follow up visit at the pain center for up to 13 weeks)
- Comparison of the efficacy of rTMS on the primary outcome between patients with neuropathic pain and fibromyalgia(Week 13)
- Effects of rTMS vs sham on pain as its least from Brief Pain Inventory(Baseline then each follow up visit at the pain center for up to 13 weeks)
- Blinding assessment(13 weeks)
- Patient global impression of change(13 weeks)
- Effects of rTMS versus sham on anxiety and depressive symptoms(Baseline then each follow up visit at the pain center for up to 13 weeks)
- Effects on Global Impression of change assessed by the clinician(13 weeks (end of the treatment))
- Effects of rTMS vs sham on pain interference(Baseline then each follow up visit at the pain center for up to 13 weeks)
- Effects of rTMS vs sham on quality of life(Baseline then each follow up vist at the pain center for up to 13 weeks)
- Side effects of rTMS or sham(Each follow up visit at the pain center for up to 13 weeks)
- Effects of rTMS vs sham on pain as its worst from Brief Pain Inventory(Baseline then each follow up visit at the pain center for up to 13 weeks)
研究者
Nadine ATTAL
Clinical Professor
Hospital Ambroise Paré Paris
研究点 (4)
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