Effects of Bodily Illusion and tDCS on Spinal Cord Injury (SCI) Related Neuropathic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change in Neuropathic Pain Severity
研究概览
简要总结
The purpose of this study is to evaluate the effect of a combination of two procedures: (1) Bodily Illusion (BI) and (2) Transcranial direct electrical stimulation (tDCS) on neuropathic pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants will be men or women, 18-70 years of age, with an incomplete cervical traumatic SCI.
- •Participants must have experienced neuropathic pain for a minimum of six months. They must have neuropathic pain in the moderate to severe category, which will be defined as a score of at least 4 on a Numeric Rating Scale (NRS); (range of 0 to 10).
- •Participants must be willing and able to sign informed consent
排除标准
- •Major psychiatric disease/disorder (self-reported)
- •A significant neurological trauma besides SCI
- •A recent (one-year) history of alcohol or drug abuse (selfreported)
- •Any other medical conditions in which transcranial DCS is relatively contraindicated, such as pregnancy, epilepsy and/or seizures
研究组 & 干预措施
BI-TDCS Stimulation Group
Participants in this group will receive the BI and TDCS interventions for 10 sessions over two weeks.
干预措施: Bodily Illusions (BI) Procedure (Other)
BI-TDCS Stimulation Group
Participants in this group will receive the BI and TDCS interventions for 10 sessions over two weeks.
干预措施: Transcranial direct electrical stimulation (tDCS) (Device)
BI-TDCS (Sham) Stimulation Group
Participants in this group will receive the BI and TDCS (Sham) interventions for 10 sessions over two weeks.
干预措施: Bodily Illusions (BI) Procedure (Other)
BI-TDCS (Sham) Stimulation Group
Participants in this group will receive the BI and TDCS (Sham) interventions for 10 sessions over two weeks.
干预措施: Sham Transcranial Direct Electrical Stimulation (tDCS) (Other)
结局指标
主要结局
Change in Neuropathic Pain Severity
时间窗: baseline, up to two weeks
Assessed by the use of the Neuropathic Pain Symptom Inventory (NPSI). The NPSI has a total score ranging from 0 to 100 with the higher score indicating greater pain.
Change in Performance of Body Part Processing
时间窗: baseline, up to two weeks
Assessed by a customized computer task, where individual reaction times will be measured in response to mental rotation of body parts. Results will be reported in milliseconds.
次要结局
- Change in Sensory Thresholds(baseline, up to two weeks)
研究者
Eva Widerstrom-Noga
Research Professor
University of Miami