TMS Neuromodulation of Brain-to-Stomach Circuits in Chronic Nausea
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 219
- 试验地点
- 1
- 主要终点
- GMEP location
研究概览
简要总结
The goal of this study is to determine whether stimulation of the brain-stomach connection can influence stomach activity in healthy adults and in individuals suffering from chronic nausea. The main questions it aims to answer are:
- What are the best brain sites to influence the stomach?
- What are the effects of different stimulation patterns on stomach activity?
- Does the stimulation affect the sensation of nausea in participants suffering from chronic nausea?
Researchers will use a non-invasive method of brain stimulation called Transcranial Magnetic Stimulation (TMS) and will record stomach responses with skin electrodes on the abdomen.
Participants will:
- Visit the clinic at least once, and for up to 9 times more over the course of several months.
- Receive TMS while sitting in a chair similar to a dentist's chair.
- Drink water or consume a test meal during each study visit.
详细描述
This study will use cutaneous recordings of stomach activity (electrogastrogram, EGG) and non-invasive brain stimulation with Transcranial Magnetic Stimulation (TMS) to
- map descending cerebral cortical-to-stomach circuitry via gastric motor-evoked potentials (GMEPs),
- use repetitive TMS (rTMS) applied to GMEP hotspots to modulate the stomach response to a satiety task (water load or nutrient drink/meal),
- assess differences in topography and function of cortical-to-stomach circuitry between healthy subjects and subjects suffering from chronic nausea vomiting syndrome (CNVS).
Some clinical, demographic, and autonomic data (i.e. EKG) will be recorded and used as covariates to investigate any systematic impact on the outcome measures.
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
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults between ages 21-60 years old, with and without CNVS diagnosis per self-report.
排除标准
- •body mass index (BMI) > 30
- •pregnancy or intention to become pregnant
- •past or present chemotherapy
- •diagnosis of gastric (stomach) cancer
- •any kind of gastric (stomach) surgery
- •current use of GLP-1 receptor agonists (e.g. Ozempic, Trulicity)
- •medications which significantly lower seizure thresholds (e.g. bupropion (Wellbutrin), fluoxetine (Prozac), or tramadol (Ultram))
- •implantable devices, such as a pacemakers or nerve stimulators
- •history of head injury that required hospitalization, metal in the skull, or neurologic disease such as stroke, history of seizures or history of syncope (fainting or passing out)
- •neurodegenerative disease (Multiple Sclerosis, Parkinson's or Alzheimer's Disease)
- •ongoing psychosis or altered cognitive status status (e.g. hearing sounds or seeing visions that are not there, or feeling confused or suffering from memory lapses)
- •history of cardiovascular (i.e., heart attack), pulmonary (i.e., need for supplemental oxygen), or endocrine disease (e.g. diabetes)
- •current enrollment in another study using Transcranial Magnetic Stimulation (TMS)
- •current use of drugs such as amphetamines, methamphetamine, Ecstasy, Ketamine, Angel Dust/PCP, cocaine, or drinking 3 or more alcoholic drinks per day
- •For healthy subjects only: chronic history of gastrointestinal symptoms (e.g., nausea, indigestion, bloating, abdominal pain)
- •For CNVS subjects only: diagnosis of gastric motility disorder (e.g. gastroparesis/slow stomach emptying) or history of bowel obstruction (i.e., chronic partial small bowel obstruction)
研究组 & 干预措施
Healthy subjects and CNVS subjects
Subjects without gastric problems and subjects with Chronic Nausea and Vomiting (CNVS)
干预措施: Transcranial Magnetic Stimulation, TMS (Device)
结局指标
主要结局
GMEP location
时间窗: Baseline session
Location of GMEP hotspot(s) in M1 and/or premotor areas relative to FDI hotspot
EGG power change
时间窗: Each study session through study completion, up to 1 year
Change in spectral power of the EGG in the 3 cpm frequency band associated with the gastric filling task (water load or test meal), either followed or not by neuromodulatory rTMS
次要结局
- GMEP amplitude(Each study session through study completion, up to 1 year)
- Volume(Each study session through study completion, up to 1 year)
- Nausea severity (only participants suffering from chronic nausea)(Each study session through study completion, up to 1 year)
研究者
David Levinthal
Associate Professor
University of Pittsburgh