胃电刺激治疗胃轻瘫患者腹痛 (HEAL)

有源比较器：名义GES参数

使用受试者临床处方标准的Enterra™刺激器，进行持续24小时的胃电刺激。

设备：Enterra™神经刺激器

使用植入式Enterra™神经刺激器并按照方案指定的编程参数进行胃电刺激。

实验性的：特殊参数GES

短周期刺激（开0.3秒/关0.2秒；脉冲宽度0.24毫秒；频率100赫兹；振幅4-6毫安）每八小时持续一小时，其余时间使用标称设置。

设备：Enterra™神经刺激器

使用植入式Enterra™神经刺激器并按照方案指定的编程参数进行胃电刺激。

实验性的：改良的Enterra参数

持续24小时刺激（3秒开/2秒关；0.33毫秒脉宽；14赫兹频率；15-20毫安幅度）。

设备：Enterra™神经刺激器

使用植入式Enterra™神经刺激器并按照方案指定的编程参数进行胃电刺激。

腹痛评分的变化

使用11点数字评分量表（0=无痛，10=最严重的疼痛）测量的每日最严重腹痛评分在7天平均值中相对于基线的变化。

胃轻瘫主要症状指数评分变化

Change in Gastroparesis Cardinal Symptom Index (GCSI) score from baseline to 8 weeks after randomization. The Gastroparesis Cardinal Symptom Index (GCSI) is a patient-reported tool measuring the severity of gastroparesis symptoms over 2 weeks, assessing 9 items group into 3 subclasses: nausea/vomiting, fullness/early satiety, and bloating on a 0-5 scale. A total GCSI score ≥18 generally indicates moderate to severe symptoms, with lower scores indicating better symptom control.

疼痛药物的变化

在为期8周的随机治疗期间，阿片类和非阿片类止痛药物使用的变化。

炎症细胞因子的变化

通过血清检测测量，包括IL-6、TNF-α、IL-1β、IL-8和IFN-γ。

Change in Brief Pain Inventory Score

Change in Brief Pain Inventory (BPI) score from baseline to 8 weeks after randomization. The investigators will be using the Brief Pain Inventory (BPI) short form.

The Brief Pain Inventory (BPI) scoring assesses pain severity and its interference with daily life using an 11-point numeric rating scale (0 = "no pain/interference", 10 = "worst pain/complete interference").

It provides two main scores: a Pain Severity Score (average of 4 items) and a Pain Interference Score (average of 7 items), where higher scores indicate greater impairment.

Percent Reduction in Pain Score

Percent of responders defined as ≥30% reduction in pain score at 8 weeks.

The investigators will be using the Brief Pain Inventory (BPI) short form. The Brief Pain Inventory (BPI) scoring assesses pain severity and its interference with daily life using an 11-point numeric rating scale (0 = "no pain/interference", 10 = "worst pain/complete interference"). It provides two main scores: a Pain Severity Score (average of 4 items) and a Pain Interference Score (average of 7 items), where higher scores indicate greater impairment.

Change in Autonomic Function

For measurements of autonomic function, participants will undergo traditional autonomic testing, an established technique that has been extensively applied. This testing is reported a two main components: Vagal Cholinergic, via RR variation with deep breathing and Valsalva Ratio as well as Sympathetic Adrenergic, via postural adjustment ratio and vasoconstriction to cold stress.

The normal values for these are derived from extensive experience of nearly 3000 patients as well as normal controls. This testing is also performed with cutaneous electrograms, used as a combined autonomic enteric tool, for baseline, and response to cold and posture.

Change in Gastric Electrophysiology

Measured via electrogastrogram (EGG). The investigators will record mucosal and serosal measures at the time of placement of temporary GES electrodes, and before a temporary GES device is connected to the leads. The technique of mucosal electrogram recordings uses 2 leads, a proximal one in the upper gastric body and a distal one near the body antral junction, which allows for low resolution mapping of the stomach. The recordings will be analyzed by signal averaging and reported as frequency, amplitude and their ratio. All patients will also have baseline cutaneous electrograms as well, for reference, analyzed in a similar manner.