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
- 12
- 试验地点
- 2
- 主要终点
- Pain as Assessed by Visual Analogue Scale (VAS)
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 spinal cord injury patients. Note that this study will also enroll healthy volunteers, 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
- 否
入选标准
- •between 18 and 75 years
- •male and female subjects
- •has neuropathic pain after traumatic spinal cord injury
- •has chronic pain, >3 months
- •is stable on oral pain medications at least two weeks. (patients are allowed to continue their pain medications, i.e., no change in pain medications.)
排除标准
- •currently adjusting oral pain medications for their neuropathic pain
- •have pain, but not neuropathic (e.g., from inflammation at the incision wound of the residual limb or neuroma)
- •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.
研究组 & 干预措施
Combined BreEStim and tDCS, then BreEStim and tDCS sham
BreEStim is voluntary breathing controlled electrical stimulation. tDCS is transcranial direct current stimulation.
干预措施: tDCS (Device)
Combined BreEStim and tDCS, then BreEStim and tDCS sham
BreEStim is voluntary breathing controlled electrical stimulation. tDCS is transcranial direct current stimulation.
干预措施: tDCS sham (Device)
BreEStim and tDCS sham, then combined BreEStim and tDCS
BreEStim is voluntary breathing controlled electrical stimulation.
干预措施: tDCS sham (Device)
BreEStim and tDCS sham, then combined BreEStim and tDCS
BreEStim is voluntary breathing controlled electrical stimulation.
干预措施: BreEStim (Device)
BreEStim and tDCS sham, then combined BreEStim and tDCS
BreEStim is voluntary breathing controlled electrical stimulation.
干预措施: tDCS (Device)
Combined BreEStim and tDCS, then BreEStim and tDCS sham
BreEStim is voluntary breathing controlled electrical stimulation. tDCS is transcranial direct current stimulation.
干预措施: BreEStim (Device)
结局指标
主要结局
Pain as Assessed by Visual Analogue Scale (VAS)
时间窗: baseline, 10 minutes after tDCS, 10 minutes after BreEstim
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. To allow a continuous assessment of pain, VAS uses a 10 cm line labelled at '0' with 'no pain' and '10' with 'worst pain'. The line is marked at a point corresponding to the assessment of the pain.
次要结局
- Electrical Pain Threshold(baseline, 10 minutes after tDCS, 10 minutes after BreEstim)
- Electrical Sensation Threshold(baseline, 10 minutes after tDCS, 10 minutes after BreEstim)
研究者
Sheng Li
Associate Professor
The University of Texas Health Science Center, Houston