Study of the Effectiveness of Maintenance rTMS Sessions for 6 Months Versus Placebo in Subjects With Fibromyalgia Responders to 3 Week-rTMS Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 4
- 主要终点
- number of fibromyalgia subjects maintaining a clinical improvement with rTMS maintenance sessions during 6 months
研究概览
简要总结
Maintenance rTMS sessions after a successful 3week-rTMS treatment for subjects with fibromyalgia may maintain the clinical improvement.
详细描述
In a previous pilot study, a 3 week treatment with rTMS in fibromyalgia subjects induced a 40% improvement of pain feeling. Three months later, the pain level was still significantly reduced in comparison with the beginning of the treatment, but the clinical improvement was less than at the end of the treatment. We thus propose to realize real or sham rTMS sessions at 3 weeks interval during 6 months with subjects presenting a significant clinical improvement after a 3 week-rTMS or sham treatment to evaluate the response maintenance.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •presence of the criteria from the American College of Rheumatology (2010)for fibromyalgia diagnosis,
- •painful state for more than six months,
- •visual analogic scale evaluation > or = 5,
- •age between 18 and 70,
- •no modification in therapeutic treatment one month before and during the protocol
- •presence of actual or prior antalgic chronic treatment : pregabalin, duloxetine, milnacipran, gabapentin, venlafaxine, laroxyl, grade 1 or 2 antalgic
- •residence in Limoges or the periphery, or the ability to come to the hospital for the treatment
排除标准
- •presence of non stabilized psychiatric comorbidity (personality trouble, addiction, suicide attempt, non controlled affective trouble),
- •active epilepsy,
- •previous cerebral traumatism, or cerebral surgery, intra-cranial hyper tension,
- •pacemaker, metallic pieces in the brain, cochlear ocular implant, or any metallic material contra indicating magnetic resonance imaging.
- •clozapine, bupropion, methadon, theophyllin, or other non chemical antalgic technic established during the previous month(kinesitherapy, relaxation, hypnosis...),
- •pregnancy, or administrative and judiciary protection, absence of health insurance.
研究组 & 干预措施
rTMS-rTMS
subjects receiving real rTMS treatment and real rTMS maintenance sessions
干预措施: rTMS (Device)
sham - sham
subjects receiving sham treatment and presenting a clinical improvement : they will be submitted to sham maintenance sessions
干预措施: sham rTMS (Device)
rTMS-sham
subjects receiving sham rTMS maintenance sessions after successful real rTMS treatment
干预措施: rTMS (Device)
rTMS-sham
subjects receiving sham rTMS maintenance sessions after successful real rTMS treatment
干预措施: sham rTMS (Device)
rTMS
real rTMS for 3 weeks but without clinical improvement
干预措施: rTMS (Device)
sham
sham treatment for 3 weeks without clinical improvement
干预措施: sham rTMS (Device)
结局指标
主要结局
number of fibromyalgia subjects maintaining a clinical improvement with rTMS maintenance sessions during 6 months
时间窗: 210 days
= number of fibromyalgia subjects maintaining a clinical improvement after a prior rTMS treatment (15 sessions in 3 weeks)and maintenance rTMS sessions administered at 42, 63, 84, 105, 126, 147, 168, 189, 210 days after inclusion in comparison with sham maintenance sessions. clinical improvement is described as a 30% decrease from baseline in pain feeling (visual analogue scale) and a response ≥ 6 for the Patient's global impression of Change. effect will be considered as maintained if criteria of clinical improvement present after 3 week rTMS treatment are conserved at 6 months rTMS or sham maintenance sessions.
次要结局
- number of rTMS responders at 3week-rTMS treatment(21 days)
研究者
Jean-Christophe Dumont
Medical Doctor, Assistant in Rheumatologia Service CHU Limoges
Centre Hospitalier Esquirol