Neuroimaging the Impact of Respiration and Respiratory-gated Neuromodulation on Human Glymphatic Physiology
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 81
- 试验地点
- 4
- 主要终点
- functional magnetic resonance imaging (fMRI) signals
研究概览
简要总结
This study will perform magnetic resonance imaging (MRI) measurements of hemodynamics and cerebrospinal fluid flow across breathing tasks and during breath-locked neuromodulation.
详细描述
Cerebrospinal fluid (CSF) flow is essential for brain health, as it clears waste products from the brain. This study will investigate how breathing affects the flow of CSF around the brain. The investigators will perform high resolution magnetic resonance imaging (MRI) scans in participants who are breathing in specific patterns or performing simple tasks and test the effects on CSF flow. Participants will complete an imaging study visit in which the investigators will image their brain activity while they perform simple tasks, including paced breathing tasks. The participants will be split into two arms: (1) paced breathing (25 participants low resolution, 15 participants high resolution), (2) transcutaneous vagal nerve stimulation (25 participants low resolution, 15 participants high resolution). The MRI scans will take place in the 7 Tesla MRI scanner at Massachusetts General Hospital.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult age 18-70 years
排除标准
- •No ferrous metal implanted in head or body
- •No history of major head trauma
- •No neurological or psychiatric disorder
- •Not using medication that affects brain function
- •No implanted electronic devices (e.g. pacemaker)
- •No implant that poses an MR contraindication
- •Not pregnant, suspect they are pregnant, or seeking to become pregnant
- •Not claustrophobic
- •No piercings or jewelry that cannot be removed
- •Does not weigh more than 250 pounds
- •Normal or contact-corrected normal vision
- •Exclusion for transcutaneous vagus nerve stimulation (tVNS) arm:
- •Conditions of skin or anatomy that affect left auricle or forehead skin and could impact placement of electrodes for tVNS or forehead stimulation
- •Diagnosis of significant cardiovascular or cerebrovascular disease [e.g. congestive heart failure, stroke, cardiac conduction disorders (including: bundle branch block, heart block, long Q-T syndrome), history of asystole or non-sustained ventricular tachycardia.
- •Bradycardia (defined as resting heart rate <50 bpm)
- •Hypotension defined as blood pressure <90/60 mmHg
研究组 & 干预措施
Transcutaneous vagal nerve stimulation
Participants will receive transcutaneous vagal nerve stimulation in specific patterns.
干预措施: Breathing task (Behavioral)
Breath task
Participants will breathe in specific patterns.
干预措施: Breathing task (Behavioral)
Transcutaneous vagal nerve stimulation
Participants will receive transcutaneous vagal nerve stimulation in specific patterns.
干预措施: Transcutaneous vagal nerve stimulation (Device)
结局指标
主要结局
functional magnetic resonance imaging (fMRI) signals
时间窗: During study (2 hours)
fMRI measures of hemodynamic responses. Units: percent signal change
Cerebrospinal fluid (CSF) signals
时间窗: During study (2 hours)
MR-based measures of CSF signals. Units: percent signal change
次要结局
- Pulse oximetry(During study ( 2 hours))
- Heart rate(During study ( 2 hours))
- Respiratory physiology timing(During study (2 hours))
- Respiratory physiology amplitude(During study (2 hours))
研究者
Laura Lewis
Assistant Professor
Boston University Charles River Campus