Combined Peripheral (BreEStim) and Central Electrical Stimulation (tDCS) for Neuropathic Pain Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Electrical Pain Threshold (EPT)
研究概览
简要总结
This study looks at the effect of combined breathing-controlled electrical stimulation (BreEStim) and transcranial direct current stimulation (tDCS) on neuropathic pain after spinal cord injury, amputation, or brain injury. The hypothesis is that a single session of combined BreEStim and tDCS will produce an additive analgesic effect. This record covers the study in a population of healthy volunteers. Note that this study will also enroll spinal cord injury patients, brain injury patients, and amputation patients and that this study as applied to these other populations will be covered in separate ClinicalTrials.gov records.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- 是
入选标准
- •between 18 and 75 years
- •male and female subjects
- •healthy subjects (i.e., no recent injuries or pain)
排除标准
- •recent injuries or pain
- •have a pacemaker, or other metal and/or implanted devices
- •have amputation in their arm(s)
- •have spinal cord injury (SCI) involving impairment of arms
- •have cognitive impairment from brain injury or are not able to follow commands, or to give consent
- •have asthma or other pulmonary disease
- •are not medically stable
- •have preexisting psychiatric disorders
- •alcohol or drug abuse
- •have a history of seizures/Epilepsy, or taking benzodiazepines, anticonvulsants, and antidepressants.
- •Mini-mental state examination (MMSE), a brief 30-point questionnaire test that is commonly used in the literature, will be used to screen for cognitive impairment. A brain injury patient with a score of 24 or lower on MMSE will be excluded.
结局指标
主要结局
Electrical Pain Threshold (EPT)
时间窗: baseline, 10 minutes after tDCS, 10 minutes after BreEstim
Electrical Pain Threshold (EPT) is a type of quantitative sensory test that assesses the lowest electrical current that first evokes a sensation of pricking pain.
Electrical Sensation Threshold (EST)
时间窗: baseline, 10 minutes after tDCS, 10 minutes after BreEstim
Electrical Detection Threshold (EDT) is a type of Quantitative sensory test that assesses the lowest electrical current that first evokes an electrical sensation.
次要结局
未报告次要终点
研究者
Sheng Li
PhysicianProfessor
The University of Texas Health Science Center, Houston