Investigation of Low-intensity Focused Ultrasound Pressure
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- MRI
研究概览
简要总结
Investigating the relationship between input pressure of low-intensity focused ultrasound and an evoked potential in both eeg and fMRI.
详细描述
Study aims to determine safety and efficacy of variable pressures of low-intensity focused ultrasound using an electrical stimulation to create a somatosensory evoked potential and record eeg and fMRI outcome measures. A primary safety study will be conducted prior to 'full scale' data collection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
No masking, no sham. All subjects will receive all conditions, all of which are active.
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
- •Claustrophobia (scanning environment may be uncomfortable).
- •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 (e.g. Alzheimer's)
- •History of neurologic disorder. (e.g. Parkinson's, Epilepsy, or Essential Tremor)
- •History of head injury resulting in loss of consciousness for >10 minutes.
- •History of alcohol or drug dependence (through self-report).
研究组 & 干预措施
EEG
Electrical stimulation utilized to generate SEPs, performed pre and post LIFU application. One of three LIFU pressures will be applied. One per study visit (3), randomized order. EEG collected throughout visit (outcome measure).
干预措施: low-intensity focused ultrasound - high pressure (Device)
fMRI
Electrical stimulation utilized to generate SEPs, performed pre and post LIFU application. One of three LIFU pressures will be applied. One per study visit (3), randomized order. fMRI collected throughout visit (outcome measure).
干预措施: low-intensity focused ultrasound - low pressure (Device)
Safety Check - high pressure application
Small cohort to be collected prior to other study cohorts. Highest of 3 pressures of interest will be applied to the S1 (somatosensory cortex) with a follow-up MRI conducted 24-72 hours post.
干预措施: low-intensity focused ultrasound - high pressure (Device)
EEG
Electrical stimulation utilized to generate SEPs, performed pre and post LIFU application. One of three LIFU pressures will be applied. One per study visit (3), randomized order. EEG collected throughout visit (outcome measure).
干预措施: low-intensity focused ultrasound - low pressure (Device)
EEG
Electrical stimulation utilized to generate SEPs, performed pre and post LIFU application. One of three LIFU pressures will be applied. One per study visit (3), randomized order. EEG collected throughout visit (outcome measure).
干预措施: low-intensity focused ultrasound - medium pressure (Device)
fMRI
Electrical stimulation utilized to generate SEPs, performed pre and post LIFU application. One of three LIFU pressures will be applied. One per study visit (3), randomized order. fMRI collected throughout visit (outcome measure).
干预措施: low-intensity focused ultrasound - medium pressure (Device)
fMRI
Electrical stimulation utilized to generate SEPs, performed pre and post LIFU application. One of three LIFU pressures will be applied. One per study visit (3), randomized order. fMRI collected throughout visit (outcome measure).
干预措施: low-intensity focused ultrasound - high pressure (Device)
结局指标
主要结局
MRI
时间窗: pre and post intervention in cohort 1
pre and post structural MRI collection for cohort one - evaluated by Neuroradiologist for safety considerations. Primarily looking to rule out any evidence of bleeds.
Report of Symptoms Questionnaire
时间窗: pre/post intervention and 1 week post intervention.
questionnaire of symptomology administered pre and post intervention.
次要结局
- EEG(throughout study visits in cohort 2 - approximately 2 hours per visit across 3 study visits (~2 weeks).)
- fMRI(throughout study visits in cohort 3 - approximately 2 hours per visit across 3 study visits (~2 weeks).)
研究者
Wynn Legon
Assistant Professor
Virginia Polytechnic Institute and State University