NCT01781065已完成2 期
The Analgesic Effect of Transcranial Direct Current Stimulation Over the Primary Motor Cortex on Central Neuropathic Pain Patients With Spinal Cord Injury
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Numeric rating scale for average pain over the preceding 24h
研究概览
简要总结
The purpose of this study is to evaluate the analgesic effect of transcranial direct current stimulation (tDCS) applied on motor cortex in patients with spinal cord injury who have chronic neuropathic pain.
详细描述
- anodal stimulation of the primary motor cortex (M1)
- anode electrode: C3 (EEG 10/20 system)
- cathode electrode: contralateral supraorbital area
- constant current of 2mA intensity for 20 min
- twice a day with a more than 4 hours interval during of 2 weeks (from Monday to Friday, total 20 treatment session)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elapsed time since spinal cord injury more than 6 months
- •stable chronic pain for at least 3 preceding months
- •pain that was not attributable to cause other that neuropathic pain
- •pain that was resistant to various types of medications or physical or complementary medicine treatment
排除标准
- •any kind of metal implant in the head
- •heart disease including having a cardiac maker
- •family or personal history of epilepsy, or neuropsychiatric illness
结局指标
主要结局
Numeric rating scale for average pain over the preceding 24h
时间窗: before the first tDCS session, and 1, 2, 4, 6 and 8 wk after the start of the stimulation
次要结局
- Patient global impression of change for pain(before the first tDCS session, and 1, 2, 4, 6, and 8 wk after the start of the stimulation)
研究者
Hyung-Ik Shin
Associate Professor
Seoul National University Bundang Hospital
研究点 (2)
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