Selecting the Right Patient for Gastric Electrical Stimulation: Using Blinded Temporary Stimulation Trials in Children and Adolescents

IF 3.7 3区医学 Q2 CLINICAL NEUROLOGY

Neuromodulation Pub Date : 2026-10-01 Epub Date: 2026-01-13 DOI:10.1016/j.neurom.2025.12.004

Andrea Geleni Gongora BS, Christel Gharby MD, Madison Wnuk MD, Thomas Abell MD, Saleem Islam MD, MPH

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引用次数: 0

Abstract

Background

Gastric electrical stimulation (GES) has been shown to relieve symptoms in children with gastroparesis (GP). Currently, trials with temporary gastric stimulation (tGES) guide selection for permanent implantation; however, there remain several nonresponders and early failures requiring early device explant. This study reports our experience with patient selection with “blinding” during their tGES trial.

Materials and Methods

A cohort study was conducted in patients aged four to 26 years who underwent blinded (B) and nonblinded (NB) tGES for GP from January 2014 to April 2022. B cases began the trial as either ON or OFF and then crossed over. Gastroparesis Cardinal Symptom Index (GCSI), nutritional intake, and permanent stimulator implant outcomes were measured and compared between the groups using Fisher exact test.

Results

A total of 84 patients underwent tGES, of whom 57 were NB and 27 B. Of the NB, 55 (96.5%) had improved GCSI, of whom 49 (86%) underwent permanent implantation. In the B group, 14 (51.9%) showed improvement when ON and worsened when OFF (concordant), whereas the others had either discordant or no response to the ON/OFF phase; 12 of 27 B cases (44.4%) were implanted. Early failures were noted in one of 12 B vs nine of 49 in NB cases (p = 0.67).

Conclusions

Overall, GES remains an effective therapy for severe GP in children and adolescents. Blinded tGES trials appeared to allow improved patient selection for those with concordant responses with lower implant rates and fewer early failures. Long-term outcomes of patients who were blinded and received a permanent implant need to be further studied.

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选择合适的胃电刺激患者：在儿童和青少年中使用盲法临时刺激试验。

背景：胃电刺激（GES）已被证明可以缓解儿童胃轻瘫（GP）的症状。目前，暂时性胃刺激（tGES）的试验指导永久性植入的选择；然而，仍然有一些无反应和早期故障需要早期的设备移植。本研究报告了我们在tGES试验中采用“盲法”选择患者的经验。材料与方法：对2014年1月至2022年4月接受GP盲法(B)和非盲法（NB） tGES的4 - 26岁患者进行队列研究。B例开始试验时为ON或OFF，然后交叉。采用Fisher精确检验对胃轻瘫主要症状指数（GCSI）、营养摄入和永久性刺激器植入结果进行测量和比较。结果：84例患者行tGES，其中NB 57例，b 27例，NB 55例（96.5%）GCSI改善，其中49例（86%）行永久种植。B组14例（51.9%）患者在开/关阶段表现出改善，在关/开阶段表现出恶化（一致性），其余患者在开/关阶段表现出不一致或无反应；27例B中植入12例（44.4%）。12例B中有1例早期失败，49例NB中有9例早期失败（p = 0.67）。结论：总体而言，GES仍然是儿童和青少年严重全科病的有效治疗方法。盲法tGES试验似乎可以改善对那些具有较低植入率和较少早期失败的一致反应的患者的选择。盲法植入的患者的长期预后需要进一步研究。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Neuromodulation 医学-临床神经学

CiteScore

6.40

自引率

3.60%

发文量

978

审稿时长

54 days

期刊介绍： Neuromodulation: Technology at the Neural Interface is the preeminent journal in the area of neuromodulation, providing our readership with the state of the art clinical, translational, and basic science research in the field. For clinicians, engineers, scientists and members of the biotechnology industry alike, Neuromodulation provides timely and rigorously peer-reviewed articles on the technology, science, and clinical application of devices that interface with the nervous system to treat disease and improve function.