Modulation of Gastric Sensitivity and Accommodation by Vagal Nerve Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Neuroimaging
研究概览
简要总结
Explore the effects of variable ingested volumes and auricular transcutaneous vagal nerve stimulation (taVNS) on brain and stomach outcomes in healthy adults.
详细描述
We aim to assess and modulate gastric interoception in healthy adults using gastric and brain MRI, different meal volumes (Experiment 1), and transcutaneous auricular vagus nerve stimulation (taVNS) (Experiment 2). MR examinations will precede and immediately follow ingestion of a test meal (containing pineapple, with high manganese content, as a contrast agent), using real-time 3D cine MRI. Subjects will be scanned before ingestion and at 15, 45, and 75 minutes post-meal, in order to extract objective indices of gastric function. Functional MRI (fMRI) brain scans will be alternated to gastric MRI scans. Each subject will undergo 2 separate MRI visits, ingesting different doses of contrast meal in order to peripherally modulate gastric afference (Experiment 1), or receiving sham and active taVNS (Experiment 2), so to modulate visceral afference at the central level.Outcomes will assess the taVNS response of brainstem vagal neurocircuitry, as well as the impact of taVNS on fMRI connectivity patterns (fcMRI) of gastric afference, and link them to MRI-derived gastric outcomes, such as gastric emptying rate, gastric accommodation (fundic volumes), and gastric motility (peristaltic wave propagation).
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
- Single (Participant)
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
- •Male and female patients aged 18 and 65 years old (inclusive)
- •Comprehension of instructions
- •Avoidance of alcohol, nicotine, and caffeine for 25 hours prior to study session
排除标准
- •BMI (Body Mass Index) more than 32 and/or weight > 235 lbs. (limits of the MRI table)
- •Any other significant medical disease (systemic or CNS), psychiatric disorder, or chronic pain condition/s
- •Epilepsy or a prior history of seizures
- •Psychotropic medications or other medications that effect neurovascular coupling (i.e. fMRI)
- •Subjects taking illicit drugs or opioids
- •Allergy to pineapple (used in the test meal during MRI)
- •Contraindications for MRI: High magnetic fields may pose a serious health hazard to subjects with implanted ferromagnetic objects. Every subject in this study will be carefully screened before entering the high magnetic field shielded room to collect a precise outline of the subject's medical history. Subjects with the following characteristics/disease will not be eligible to participate in the study: -History of Head Trauma -Any metallic implants (e.g. braces or permanent retainers) -Tattoos with metallic ink above the nipple line -Surgical Aneurysm Clips -Cardiac Pacemaker -Prosthetic Heart Valve -Neurostimulator -Implanted pumps -Cochlear Implants -Metal rods, Plates -Screws -Recent Previous Surgery -IUD -Hearing Aid -Dentures (which might create NMR artifacts) -Metal Injury to eyes -Pregnancy or plans to become pregnant -Breast Feeding -Meniere's Disease -Transdermal (skin) patches such as NicoDerm (nicotine for tobacco dependence), Transderm Scop, or Ortho Evra (birth control) -Non-normally cycling females -Claustrophobia
研究组 & 干预措施
taVNS
Active taVNS
干预措施: taVNS (Device)
Sham
Sham taVNS
干预措施: Sham taVNS (Device)
结局指标
主要结局
Neuroimaging
时间窗: 2 hours
NTS connectivity
Gastric Function
时间窗: 2 hours
MRI-derived measures of gastric accommodation
Neuroimaging
时间窗: Visits 1,2,3 (2 hours)
NTS connectivity
Gastric Function
时间窗: Visits 1,2,3 (2 hours)
MRI-derived measures of gastric accommodation
次要结局
- Electrogastrography (EGG)(2 hours)
- Respiration(2 hours)
- Electrocardiography (ECG)(2 hours)
- Skin Conductance Levels (SCL)(2 hours)
研究者
Roberta Sclocco
Principal Investigator
Spaulding Rehabilitation Hospital