Biomagnetic Characterization of Gastric Dysrhythmias III
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Measurement of gastric slow wave activity in normal and diseased smooth muscle of the stomach
研究概览
简要总结
There is a tremendous clinical need for a noninvasive technique that can assess gastric electrical activity and would be repeatable without any exposure to radiation. Investigators developed a new technique allowing to use noninvasive methods to assess bioelectrical activity in the gastrointestinal system. This has enabled to characterize the normal and pathologic physiology of the stomach through the use of noninvasive magnetogastrogram (MGG) records. Primary hypothesis for this proposal is that analysis of gastric slow wave uncoupling and propagation in multichannel MGG discriminates between normal and pathological gastric electrical activity. Eventually, investigators envision this research leading to new insights for gastrointestinal conditions such as gastroparesis, functional dyspepsia and chronic idiopathic nausea that would inform clinical management of these debilitating diseases.
详细描述
5/23/25. Study record updated to reflect Early Phase 1/Phase 0 trial. The main aim of the study was to evaluate MGG as a device for classification of functional gastric disorders.
Studies have demonstrated that the magnetogastrogram (MGG) records the same gastric slow wave activity that detect with serosal and mucosal electrodes. The upgraded magnetometer will improve the spatial resolution resulting in increased sensitivity for detecting and characterizing both abnormal frequency dynamics and abnormal spatiotemporal patterns. The spatiotemporal data collected with multichannel Superconducting QUantum Interference Device (SQUID) biomagnetometer has allowed , for the first time, to characterize propagation of the gastric slow wave noninvasively. In addition to frequency dynamic changes, which are the only reliable parameters from cutaneous electrogastrogram (EGG), and which still do not necessarily correlate well with disease, the MGG reflects normal and abnormal gastric slow wave activity. Furthermore, for the first time, investigators have demonstrated that propagation characteristics determined magnetically distinguish normal subjects from patients with gastroparesis. Also for the first time, investigators have been able to detect the gradient in gastric propagation velocity noninvasively in animal subjects. However, investigators still have unresolved questions about how MGG propagation rhythm and pattern disturbances may specify functional disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants between ages 12-80
- •Diabetic patients with gastroparesis, diabetic patients without gastroparesis and who are willing to have a gastric emptying test if they have not had one in the last 6 months and an IV inserted.
- •Patients with idiopathic gastroparesis
- •Total or partial gastrectomy patients
- •Children (ages 12-17) with functional dyspepsia
- •Children (ages 12-17) with chronic nausea
排除标准
- •Those with claustrophobia who cannot lie still under the SQUID for the length of time required.
- •Normal participants with known intestinal complications
- •Pregnant females (females who are able to have children will be given a pregnancy test).
- •Morbid obesity (these patients are presumably unable to lie under the current generation of SQUID devices).
- •Patients with a history of cardiac arrhythmias, taking anticoagulants, or greater than 80 years of age will be excluded.
研究组 & 干预措施
Gastroparesis
magnetogastrogram
Diabetes with and without gastroparesis ; Idiopathic gastroparesis
干预措施: magnetogastrogram (Diagnostic Test)
Gastrectomy
magnetogastrogram
Total or partial gastrectomy group
干预措施: magnetogastrogram (Diagnostic Test)
Functional dyspepsia
magnetogastrogram
Children with functional dyspepsia
干预措施: magnetogastrogram (Diagnostic Test)
Chronic nausea
magnetogastrogram
Children with chronic nausea
干预措施: magnetogastrogram (Diagnostic Test)
Control participants
magnetogastrogram
Group without any gastrointestinal diseases.
干预措施: magnetogastrogram (Diagnostic Test)
结局指标
主要结局
Measurement of gastric slow wave activity in normal and diseased smooth muscle of the stomach
时间窗: 1 day
次要结局
- Measurement of noninvasive magnetogastrogram before and after partial/total gastrectomy.(day 1 and day 30)
- Measurement of invasive serosal electromyogram before and after partial/total gastrectomy.(day 1 and day 30)
- Measurement of gastric slow wave propagation velocity in gastroparesis patients(1 day)
- Noninvasive measurement of gastric slow wave dysrhythmia in pediatric patients with nausea and functional dyspepsia(1 day)
研究者
Alan Bradshaw
Research Assistant Professor of Surgery
Vanderbilt University Medical Center