Mechanisms and Utility of Multisensory Body- Representation in SCI and SCI-Related Neuropathic Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes associated with sensory function/dysfunction assessed by quantitative sensory testing
研究概览
简要总结
The purpose of this study is to investigate the effectiveness of bodily illusions combined with transcranial direct current stimulation (tDCS) on neuropathic pain symptoms and sensory functions in participants with spinal cord injury (SCI) and neuropathic pain.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study will be open to people of any ethnicity, racial background, and gender.
- •Inclusion criteria:
- •SCI with Pain:
- •Men or women
- •fluent in English
- •18-70 years of age who have: (3a) Complete and incomplete SCI, level of injury (above L1); (3b) Persistent neuropathic pain started after the injury for a minimum of three months prior to entering the study that is at least moderate in severity, defined as ≥ 4 on a Numeric Rating Scale (NRS) ranging 0 to 10.
排除标准
- •Participants will be excluded if they have:
- •Major psychiatric disease/disorder (self-reported);
- •a significant neurological trauma (self-reported) other than SCI;
- •a recent (one-year) history of alcohol or drug abuse assessed by the Drug Abuse Screening Test (DAST-10)
- •history of visual and hearing loss not corrected
- •history of epilepsy or seizures
- •any metal implants in the head, or implanted devices such as cochlea implants or cardiac pacemakers.
- •We will not include any special population like:
- •Adults unable to consent Individuals who are not yet adults (infants, children, teenagers) Pregnant women Prisoners
研究组 & 干预措施
SCI with pain
Participants will undergo 2-4 weeks of combined intervention including transcranial direct current stimulation (tDCS) and bodily illusions (10 sessions total).
干预措施: tDCS and bodily illusions (Other)
结局指标
主要结局
Changes associated with sensory function/dysfunction assessed by quantitative sensory testing
时间窗: Baseline, up to 4 weeks
The sensory test assesses thermal thresholds and includes: cool detection threshold (CDT), warm detection threshold (WDT), cold pain threshold (CPT), hot pain threshold (HPT), all performed using the method of limits: 0 to 50 Celsius (ºC) all values will be reported in Celsius.
Change in neuropathic pain interference assessed by pain interference questionnaire.
时间窗: Baseline, up to 4 weeks
The questionnaire consists in a numerical rating of pain interference ranging from 0= No Interference to 10=Extreme interference with activities, mood and sleep
Change in neuropathic pain severity assessed by Neuropathic Pain Symptom Inventory (NPSI)
时间窗: Baseline, up to 4 weeks
The NPSI is a self-reported, validated questionnaire that includes 10 items (on different pain sensations, e.g., burning, squeezing, electric-shock, etc.) used to evaluate the properties of neuropathic pain. Each item is scored on an 11-point NRS (0 meaning no symptom and 10 meaning worst symptom), with higher scores indicating more severe neuropathic pain symptoms.
次要结局
- Changes of psychosocial assessed by Multidimensional Pain Inventory (pain severity subscale)(Baseline, up to 4 weeks)
- Change in Global impression of changes by PGIC questionnaire(Baseline, up to 4 weeks)
- Change in manageable pain assessed by days of manageable pain questionnaire.(Baseline, up to 4 weeks)
研究者
Eva Widerstrom-Noga
Professor
University of Miami