Noninvasive Brain Stimulation for Pain Relief
试验速览
- 阶段
- 不适用
- 入组人数
- 149
- 试验地点
- 2
- 主要终点
- Numeric Pain Rating Scale
研究概览
简要总结
Non-invasive brain stimulation techniques, transcranial magnetic stimulation (TMS) and transcranial focused ultrasound (FUS), is be applied to healthy human subjects, acute pain patients, and chronic pain patients to investigate their uses for pain relief.
详细描述
The research team will be using non-invasive brain stimulation techniques, transcranial magnetic stimulation (TMS) and transcranial focused ultrasound (FUS) to investigate their uses for pain relief in humans: healthy human subjects, acute pain patients, and chronic pain patients. Magnetic Resonance Imaging (MRI) and electroencephalogram (EEG) recordings will be collected to achieve the following objectives:
Objective 1 aims to determine the effects of noninvasive brain stimulation on the pain-related brain activities during pain processing. We hypothesize that noninvasive brain stimulation approaches will increase or decrease cortical activity upon processing painful input.
Objective 2 aims to determine the effects of noninvasive brain stimulation on pain intensity and/or pain-related behavioral assessments. We hypothesize that noninvasive brain stimulation will influence pain-intensity and/or pain-related behavioral assessments.
Objective 3 aims to investigate the correlation between brain activity and pain relief after noninvasive brain stimulation. We hypothesize that noninvasive brain stimulation will suppress cortical activity in pain-related brain areas, reduce pain intensity, and/or improve pain-related behavioral assessments.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults between 18 and 80 years of age.
- •Chronic and Acute pain patients: must have an MRI (for ultrasound targeting)
排除标准
- •Direct report to the study team member
- •History of brain surgery
- •History of seizure
- •Have alcohol consumption exceeding 50 drinks/month
- •Have history of opioid abuse (all subjects), or any recent opioid use (healthy controls)
- •Have implant like pacemaker and aneurysm clip
- •Current of psychiatric disease such as anxiety or depression, which is not optimally treated
- •Current infection
- •Current wound on the skin of upper and lower extremities
- •Chronic pain patients: current chronic pain is not optimal controlled by pain medications (i.e. Pain VAS >5)
结局指标
主要结局
Numeric Pain Rating Scale
时间窗: immediately after experimental pain measure (up to 15 minutes after baseline) as compared to baseline
Participants will rate their pain (experimental, acute, chronic) on a 1-10 scale
次要结局
未报告次要终点