Cortical Modulation With Transcranial Direct Current Stimulation (tDCS) for Neuropathic Symptoms Following Burn Injury.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Effect of tDCS on pain/itch perception
研究概览
简要总结
The purpose of this study is to investigate the effects of transcranial direct current stimulation (tDCS) on the neuropathic symptoms (pain/itch) due to a burn injury. The investigators hypothesize that the active tDCS group will show a significant pain/itch reduction 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
- Basic Science
- 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:
- •Providing informed consent to participate in the study
- •18 to 64 years old
- •Any size closed wound from burn injury, occurring at least 3 weeks prior to enrollment in the study.
- •Subjects with burns in scalp area will be excluded from the study as the electrode may cause irritation to the injuries
- •Use of regular medications for pain and/or itching control at stable doses for at least 3 weeks prior to enrollment in the study
- •No contraindications to tDCS:
- •metallic implants in the head
- •implanted brain medical devices
- •Subject is not pregnant at the time of enrollment
- •Neuropathic pain or itching (rated at least 4 on the VAS) within the burn scar or donor site, (pain can be described as burning, stabbing, piercing, pins and needles, tearing sensation) for at least 3 weeks.
- •Please note: If a patient reports pain and itching, we will enroll the patient based upon their most dominant symptom.
排除标准
- 未提供
结局指标
主要结局
Effect of tDCS on pain/itch perception
时间窗: Measured for approximately 2 weeks
Determine whether active tDCS offers a greater benefit on pain reduction in patients with neuropathic symptoms (itch/pain) following burns as compared with sham tDCS. We hypothesize that active tDCS will be associated with a larger pain/itch reduction, as indexed by the Visual Analogue Scale for Pain/Itch (VAS). The subject's VAS score will be measured immediately before the tDCS stimulation sessions and after the tDCS stimulation sessions for the duration of their participation in the trial.
次要结局
- Effect of tDCS on motor cortex excitability(Measured for approximately 2 weeks.)
研究者
Felipe Fregni
Principal Investigator
Spaulding Rehabilitation Hospital