Investigation of Low-intensity Focused Ultrasound to the Salience Network on Autonomic Function
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Sympathetic tone response - Heart Rate Variability (HRV)
研究概览
简要总结
Studying the effects of Low Intensity Focused Ultrasound (LIFU) to the dorsal posterior insula (dPI) and dorsal anterior cingulate cortex (dACC) on autonomic control using a test to probe the autonomic system. A cold pressor task will be performed pre and post LIFU application. Physiologic recordings will be recorded throughout.
详细描述
Characterize the effect of LIFU to the bilateral dorsal posterior insula (dPI) and dorsal anterior cingulate cortex (dACC)) on autonomic control. The dPI is a critical brain area involved in autonomic function, being a core recipient of ascending pain and autonomic function. Similarly, the dACC has been strongly implicated in autonomic control and works with the insula for autonomic processing. Inconveniently, these brain regions lie deep to the cortex, prohibiting access using conventional noninvasive methods like transcranial magnetic stimulation (TMS). LIFU can be focused at depth to reach the insula and ACC with high spatial precision. However, the effect of LIFU to the human dPI and dACC on autonomic control is unknown. To address this, the investigators will target the right dPI and the dACC to assess how LIFU to each of these areas affects autonomic responses and subjective report to the cold pressor task, a safe, reproducible autonomic challenge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Sham application during a single randomized session (1 of 3 sessions).
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
- •Does not meet
排除标准
- •Exclusion Criteria:
- •The exclusion criteria below are regularly implemented in MRI, CT, and EEG experiments for the safety of the subjects and for data quality assurance.
- •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 central nervous system (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).
- •History of cardiac disease
- •A current or prior use of any cardiac medication (e.g. beta blockers or other anti-arrhythmics)
- •A history of diabetes mellitus or use of diabetic medications (e.g. metformin).
研究组 & 干预措施
ACC
LIFU to the ACC
干预措施: Low-intensity focused ultrasound neuromodulation (Device)
Sham
Sham LIFU application
干预措施: Sham Low-intensity focused ultrasound (Device)
dPI
LIFU to the dPI
干预措施: Low-intensity focused ultrasound neuromodulation (Device)
结局指标
主要结局
Sympathetic tone response - Heart Rate Variability (HRV)
时间窗: through study completion, an average of 1 month
Changes in HRV
Sympathetic tone response - Heart Rate (HR)
时间窗: through study completion, an average of 1 month
Changes in HR
Sympathetic tone response - Electroencephalography (EEG)
时间窗: through study completion, an average of 1 month
Changes in low and high frequency power
Sympathetic tone response - Blood Pressure (BP)
时间窗: through study completion, an average of 1 month
Changes in BP (systolic and diastolic pressure)
Sympathetic tone response - Electrodermal Response (EDR)
时间窗: through study completion, an average of 1 month
Changes in EDR
次要结局
未报告次要终点
研究者
Wynn Legon
Assistant Professor
Virginia Polytechnic Institute and State University