Investigation of Low-intensity Focused Ultrasound for Human Pain Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Perceived sensation score
研究概览
简要总结
This project examines the effects of noninvasive brain stimulation on pain. The investigators believe this study will help to better understand possible treatments for chronic pain patients. Participants undergo structural imaging, a functional Magnetic Resonance Image (fMRI) and computed tomography (CT). These images are used to align the low-intensity focused ultrasound (LIFU) device which uses sound waves to temporarily change brain activity. Pain testing is done using a small device that will increase/decrease the temperature of the skin. Brain signals are collected using electroencephalography (EEG). Heart rate, blood pressure, and skin moisture will be monitored as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Sham trials will be utilized within subject. All subjects will receive sham and ultrasound conditions.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Understand and speak English
排除标准
- •MRI/CT/EEG contraindications.
- •Claustrophobia
- •Contraindications to MRI: including pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.
- •Contraindications to CT: pregnancy
- •Active medical disorder or treatment with potential CNS effects
- •History of neurologic disorder
- •History of head injury resulting in loss of consciousness for >10 minutes.
- •History of alcohol or drug dependence
- •Failure to provide Social Security Number or Tax ID number. This is required for tax purposes or payment cannot be processed.
研究组 & 干预措施
Pain Trials
Multi visit - LIFU/Sham application, with quantitative sensory testing (using peltier device).
干预措施: Low Intensity Focused Ultrasound (Device)
结局指标
主要结局
Perceived sensation score
时间窗: Assessed per participant, over the course of participation - an average of 3 weeks.
Changed perceived sensation score on a 1-10 scale in response to painful stimuli.
次要结局
- Windup Pain(Assessed per participant, over the course of participation - an average of 3 weeks)
- CHEP Amplitude(Assessed per participant, over the course of participation - an average of 3 weeks)
研究者
Wynn Legon
Assistant Professor
Virginia Polytechnic Institute and State University