Predicting Pain Response to Transcranial Direct Current Stimulation for Phantom Limb Pain in Limb Amputees
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Pain as Measured by the Visual Analog Scale
研究概览
简要总结
This study explores the effects transcranial Direct Current Stimulation (tDCS, Soterix ©) on Phantom Limb Pain for patients experiencing chronic phantom limb pain in open-label study design.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide informed consent to participate in the study.
- •Subject is older than 18 years.
- •3 months of phantom limb pain (experienced regularly for at least once a week) after the amputated limb has completely healed.
- •Average pain of at least 4 on a numeric rating scale in the previous week (NRS; ranging from 0 to 10).
- •If the subject is taking any medications, dosages must be stable for at least 2 weeks prior to the enrollment of the study.
排除标准
- •Pregnancy or trying to become pregnant in the next 2 months.
- •History of alcohol or drug abuse within the past 6 months as self-reported.
- •Presence of the following contraindication to transcranial direct current stimulation Ferromagnetic metal in the head (e.g., plates or pins, bullets, shrapnel) Implanted head electronic medical devices (e.g., cochlear implants)
- •Head injury resulting in loss of consciousness for at least 30 min or pos-traumatic amnesia for greater than 24 hours, as self-reported
- •Unstable medical conditions (e.g. uncontrolled diabetes, uncompensated cardiac issues, heart failure or chronic obstructive pulmonary disease).
- •Uncontrolled Epilepsy
- •Suffering from severe depression (as defined by a score of >30 in the Beck Depression Inventory).*
- •History of unexplained fainting spells or loss of consciousness as self-reported during the last 2 years.
- •History of neurosurgery, as self-reported.
结局指标
主要结局
Pain as Measured by the Visual Analog Scale
时间窗: Change in outcome from baseline to 2-week follow-up (after the last day of stimulation)
The VAS is a common assessment used which asks subjects to self-reportedly measure their pain on a visual scale (i.e., unbearable to none). We will use a VAS to determine subjects' pain scores. Subjects will rate their pain from 0 - indicating no pain at all, to 10 - indicating the worst pain felt. This scale is also colored, from green (at 0) to red (at 10), as a visual indicator of pain.
次要结局
未报告次要终点
研究者
Felipe Fregni, MD, PhD, MPH
Principal Investigator
Spaulding Rehabilitation Hospital