Exploration of Parameters of tDCS in Chronic Pain Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Change in pain scales
研究概览
简要总结
The purpose of this study is to assess the effects of high-definition transcranial direct current stimulation (HD-tDCS) on subjects with chronic musculoskeletal pain. The investigators hypothesize that subjects will show a decrease in pain symptoms in the active anodal stimulation group when compared to sham stimulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •STUDY ELIGIBILITY CRITERIA
- •Inclusion Criteria:
- •Providing informed consent to participate in the study
- •18 to 64 years old
- •Having chronic musculoskeletal pain (existing pain for more than 6 months with an average of at least 3 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.
- •Must have the ability to feel pain as self reported
排除标准
- •Contraindications to tDCS
- •metal in the head
- •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)
- •History of neurological disorders as self reported.
- •History of unexplained fainting spells as self reported,
- •History of head injury resulting in more than a momentary loss of consciousness as self reported
- •History of neurosurgery as self reported
结局指标
主要结局
Change in pain scales
时间窗: Measured for approximately 5 weeks
Determine whether anodal or cathodal hd-tDCS is effective in reducing pain in subjects with chronic musculoskeletal pain as measured by changes in the Visual Analogue Scale (VAS) for pain. The VAS scale will be measured immediately before the hd-tDCS stimulation sessions and after the hd-tDCS stimulation sessions for each subject for the duration of their participation in the trial. This outcome will also be measured at their baseline visit, and follow-up visit.
次要结局
- Change in cutaneous hyperalgesia/allodynia(Measured for approximately 5 weeks.)
研究者
Felipe Fregni
Principal Investigator
Spaulding Rehabilitation Hospital