Single-arm, Open-label, Phase II Trial of HD-tDCS in Fibromyalgia Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Mean number of sessions needed to achieve 50% decrease in Visual Analogue Scale (VAS)
研究概览
简要总结
The purpose of this study is to investigate the mean number of stimulation (high definition-transcranial direct current stimulation) sessions (up to 26) needed to achieve a clinical response with this response defined as a 50% decrease in Visual Analog Scale (VAS) for pain. These data will be important in defining the optimal number of sessions for future fibromyalgia subjects in Phase III trials.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Providing informed consent to participate in the study
- •18 to 85 years old, both male and female
- •Have a diagnosis of Fibromyalgia
- •Existing pain for more than 3 months with an average of at least 4 on a 0-10 VAS scale
- •Pain resistant to common analgesics and medications for chronic pain such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex and Codeine.
排除标准
- •Pregnancy
- •Contraindications to tDCS: metal in the head or implanted brain medical devices
- •History of alcohol or drug abuse within the past 6 months as self-reported
- •Use of carbamazepine within the past 6 months as self-reported
- •Severe depression (with a score of >30 in the Beck Depression Inventory)
- •Any history of epilepsy, stroke, moderate-to-severe traumatic brain injury or severe migraines
- •History of unexplained fainting spells as self-reported
- •Neurosurgery as self-reported
研究组 & 干预措施
Active anodal HD-tDCS
Subjects will undergo 20 minutes active HD-tDCS.
干预措施: High Definition transcranial Direct Current Stimulation (Device)
结局指标
主要结局
Mean number of sessions needed to achieve 50% decrease in Visual Analogue Scale (VAS)
时间窗: approximately 4.5 months
Investigate the mean number of sessions (up to 26) needed to achieve clinical response associated with the use of HD-tDCS over the primary motor cortex (M1), with response defined at a 50% decrease in baseline Visual Analogue Scale (VAS) for pain.
次要结局
- Number of subjects who achieve clinical response(Approximately 4.5 months)
- Measurement of sensory and auditory evoked potentials(Approximately 4.5 months)
研究者
Felipe Fregni
Associate Professor
Spaulding Rehabilitation Hospital