Cardiac Vagal Effects of Gastric Electrical Stimulation and Vagal Nerve Action Potentials in Vagus Nerve in Patients With Gastroparesis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Determine if GES influences vagal outflow
研究概览
简要总结
The objective of this study is to determine if Gastric Electrical Stimulation may influence vagal outflow via vagal afferent fibers that terminate in the Central Nervous System.
详细描述
All patients who are going to have a GES device implanted, or who already have the device are eligible to be part of the study. They will be followed according to the time point they enter the study and its schedule. The visit procedures will be conducted at the discretion of the investigator dependent on the clinical condition of the subject at that time. The study involves EKG and vagal nerve recordings. Three EKG electrodes will be placed (one on chest and 2 on either arms or legs). Separate electrodes will be placed on the neck overlying the vagus nerves
Baseline Visit:
Subjects who are being seen in clinic for possible gastroparesis and may be a possible candidate for GES later or will be undergoing the GES implantation may have a baseline visit. . The baseline visit can be held either at the time of the clinic visit or before the GES implantation. If the baseline visit occurs on the day of the GES implantation, 2 separate EKGs will be performed, one prior to GES pacemaker device implantation for upto a duration of 5 minutes and the second one after the implantation in the recovery room. This EKG will be performed for a total duration of upto 15 minutes with 5 minute "ON", 5 minutes :OFF" and another 5 minutes in the "ON" position. At the same visit with each EKG recording separate EKG electrode will be placed on the neck overlying the vagus nerve. Vagal nerve recordings will be documented for a total duration of upto 15 minutes with approximately 5 min at "ON", 5 min "OFF" and another 5 min "ON" settings of the stimulator in conjunction with the EKG recordings.
At the baseline visit separate EKG electrodes will also be placed on the neck overlying the vagus nerve and a 5 minute recording will be made in conjunction with the EKG recordings.\ before the implantation.
If the subjects already have the GES device implanted then a baseline visit will not be required. They will be included in the study at the time the consent form is signed and will be followed as needed according to the clinic visit schedule and at the discretion and clinical judgement of the investigator
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age.
- •Documented diagnosis of gastroparesis.
- •Will undergo implantation of a GES device or already has a GES device implanted
排除标准
- •Pregnancy
- •History of allergic reaction to EKG lead placement adhesives.
- •unable to give informed consent
研究组 & 干预措施
GES subjects
male and female patients at least 18 years of age, with gastroparesis, who will or have already undergone the implantation of a GES device
干预措施: gastric electrical stimulator (Device)
结局指标
主要结局
Determine if GES influences vagal outflow
时间窗: 2-3 years
To determine if GES may influence vagal outflow via vagal afferent fibers that terminate in the Central Nervous System; EKG electrodes will be placed on the chest, stomach, jugular, and vagas nerves. The purpose of this is to record the effects of the stimulator when on and off. The ECG signals are digitized with an ECG power amplifier, Power Lab by AD Instruments. The digitized signals are analyzed with an ECG software analysis system, Lab Chart. The analysis will look for heart rate variability, total power variability, and frequency variability. This will determine if stimulation has an effect on these levels.
次要结局
- Release of hormones(2-3 years)
- Vagus nerve anatomy(2-3 years)