An Assessment of Gastrointestinal Function Utilizing High Resolution Gastric Mapping, Gastroduodenal Manometry, and Gastric Emptying Testing With Assessment of Acute Response to Transcutaneous Auricular Vagal Nerve Stimulation.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Gastrointestinal Antral and Duodenal Phasic Pressure Activity - Motility Index
研究概览
简要总结
Dyspepsia is a common problem attributed to gastric sensorimotor dysfunctions ie, delayed, or less frequently rapid gastric emptying (GE), impaired gastric accommodation, and increased gastric sensation. Therapeutic options manage symptoms, and there is no FDA approved medical therapy for dyspepsia. There is a need for better objective understanding of sensorimotor dysfunction in dyspepsia, as well as noninvasive, efficacious, safe, and inexpensive treatments for dyspepsia.
The purpose of this research is to identify disturbances and characterize phenotypes in patients with functional dyspepsia, and to assess the correlations between symptoms (during the manometry and in daily life), gastric emptying, electrical activity (BSGM), and pressure activity (manometry).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptoms consistent with functional dyspepsia as defined by the ROME IV criteria for 6 months
- •Ability to perform appropriate informed consent
排除标准
- •Known cardiac arrhythmia or major ECG abnormalities, i.e. cardiac conduction disturbances (2nd or 3rd degree AV block, prolonged QTc interval (> 460 msec) or bradycardia (< 45 beats/minute)
- •Conditions precluding safe use of taVNS
- •Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns
- •Use of opioids
- •Vulnerable study population
- •Pregnant women
研究组 & 干预措施
Dyspeptic Patients undergoing clinically indicated gastroduodenal manometry study
First arm evaluating patients undergoing clinically indicated gastroduodenal manometry evaluation with concurrent body surface gastric mapping (BSGM), with taVNS applied during the studies.
干预措施: tVNS (Device)
Dyspeptic Patients undergoing clinically indicated gastroduodenal manometry study
First arm evaluating patients undergoing clinically indicated gastroduodenal manometry evaluation with concurrent body surface gastric mapping (BSGM), with taVNS applied during the studies.
干预措施: Alimetry (Device)
Dyspeptic Patients undergoing clinically indicated gastroduodenal manometry study
First arm evaluating patients undergoing clinically indicated gastroduodenal manometry evaluation with concurrent body surface gastric mapping (BSGM), with taVNS applied during the studies.
干预措施: Gastroduodenal Manometry (Device)
Dyspeptic patients not undergoing GDM, tested with body surface gastric mapping alone
Participants who have been seen in the clinical setting, having undergone other clinically indicated testing, will be recruited to undergo body surface gastric mapping (BSGM). At the end of the protocolized BSGM study the patient will undergo taVNS intervention.
干预措施: Alimetry (Device)
Dyspeptic patients not undergoing GDM, tested with body surface gastric mapping alone
Participants who have been seen in the clinical setting, having undergone other clinically indicated testing, will be recruited to undergo body surface gastric mapping (BSGM). At the end of the protocolized BSGM study the patient will undergo taVNS intervention.
干预措施: tVNS (Device)
结局指标
主要结局
Gastrointestinal Antral and Duodenal Phasic Pressure Activity - Motility Index
时间窗: During gastrointestinal motility study (approx. 8 hours)
Composite measure combining frequency and amplitude for overall assessment of motility
Principal Gastric Frequency
时间窗: During gastrointestinal motility study (8 hours)
Dominant frequency of gastric waves (cycles per minute)
BMI-Adjusted Amplitude
时间窗: During gastrointestinal motility study (8 hours)
Amplitude of the gastric myoelectrical signals adjusted for body mass index
Gastric Alimetry Rhythm Index (TM)
时间窗: During gastrointestinal motility study (8 hours)
Concentration of power within the gastric frequency band over time, stability of gastric rhythm
Fed:Fasted Amplitude Ratio
时间窗: During gastrointestinal motility study (8 hours)
Ratio compares the amplitude of gastric myoelectrical activity in the fed state to the fasting state, reflecting gastric response to a meal
Gastrointestinal Antral and Duodenal Contraction Frequency
时间窗: During gastrointestinal motility study (approx. 8 hours)
Summarized as frequency (number of contractions per minute)
Gastrointestinal Antral and Duodenal Contraction Amplitude
时间窗: During gastrointestinal motility study (approx. 8 hours)
Summarized as amplitude (strength of contractions)
次要结局
未报告次要终点
研究者
Nicholas Oblizajek
Principal Investigator
Mayo Clinic