NCT01229852已完成不适用
Treatment of Fibromyalgia Using Deep Shaped-Field (DSF) Transcranial Magnetic Stimulation (TMS): A Clinical Feasibility Study
Cervel Neurotech, Inc.2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2010年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Change from Baseline on the Brief Pain Inventory (BPI)
研究概览
简要总结
Deep shaped-field transcranial magnetic stimulation is a new type of transcranial magnetic stimulation technology which may provide a drug-free method for treating fibromyalgia.
The purpose of this study is to determine the effectiveness and the durability of effect of Deep shaped-field repetitive transcranial magnetic stimulation (rTMS) in men and women diagnosed with fibromyalgia.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fibromyalgia as diagnosed by American College of Rheumatology (ACR) criteria.
- •Moderate or severe pain from fibromyalgia despite current treatment regimen.
- •Will not become pregnant during study.
排除标准
- •Seizure disorder.
- •Metal implants on or in brain, spinal cord, ear, eye or heart.
- •Current use of proconvulsant medications (e.g., bupropion).
- •Taking oral amitriptyline > 100 mg once daily at bedtime.
- •Nonscheduled analgesic, anticonvulsant or antidepressant medications.
- •Severe depression or suicidality.
- •Other significant psychiatric disorder.
- •Previous use of TMS.
结局指标
主要结局
Change from Baseline on the Brief Pain Inventory (BPI)
时间窗: Daily during 20 day treatment
次要结局
- Change from Baseline on the Beck Depression Inventory Second Edition (BDI-II)(1, 6, 10, 15 day of treatment; 1 day, 4 weeks post treatment)
- Change from Baseline for the Fibromyalgia Impact Questionnaire (FIQ)(1, 10 day of treatment; 1 day and 4 weeks post treatment)
- Durability, safety and tolerability(Measured weekly up to 1 month after treatment)
研究者
研究点 (2)
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