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Abstract
Background Gastric electric stimulation (GES) is a treatment approach to refractory gastroparesis, possibly acting centrally via afferent vagus nerve stimulation (VNS). Non-invasive VNS (nVNS) is a potential alternative to GES that could eliminate the safety risks of or identify likely responders to implantable neurostimulators.
Objective This open-label proof-of-concept study assessed the effects of nVNS in patients with severe drug-refractory gastroparesis.
Methods Patients used the Gastroparesis Cardinal Symptom Index (GCSI) to grade symptoms in diaries daily for 2 weeks before treatment (baseline) and during ≥3 weeks of nVNS therapy. Adverse events (AEs) were also diarised. Treatment was self-administered using an nVNS device (gammaCore, electroCore) and consisted of 120 s stimulations to the vagus nerve in the neck (two stimulations to each side three times daily during weeks 1 and 2; three stimulations to each side three times daily during week 3 and beyond). Response was defined as a ≥1 point decrease from baseline in GCSI score.
Results Thirty-five patients enrolled; 23 were compliant with study procedures and were included in the analysis; 7 continued treatment beyond 3 weeks. Response rates were 35% (8/23) at 3 weeks and 43% (10/23) for the duration of therapy (3–6 weeks). For the entire cohort and the 10 responders, improvements from baseline were noted for mean total GCSI and GCSI subscale scores (nausea/vomiting, postprandial fullness/early satiety, bloating). No serious AEs were reported.
Conclusions These preliminary results provide a signal that nVNS may be useful for treating refractory gastroparesis. Larger controlled studies are warranted.
- GASTROPARESIS
- AUTONOMIC NERVOUS SYSTEM
- NERVE - GUT INTERACTIONS
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Footnotes
Contributors OE is the guarantor of the article and takes responsibility for the integrity of the work as a whole, from inception to publication. OE conceived the study, helped develop the protocol, provided oversight and authored the manuscript. EP was responsible for training patients to use gammaCore and record data; she also collected and collated diary data, participated in data analysis and helped write the manuscript. DN assisted with patient training, clinical follow-up and data collection. FJ was involved in patient recruitment and clinical follow-up and contributed to the manuscript. JM and EL helped develop the clinical protocol. All authors approved the final version of the article, including the authorship list.
Funding This study was supported in part by an unrestricted grant from electroCore, Basking Ridge, New Jersey. Editorial support from MedLogix Communications was funded by electroCore and was provided under the direction of the authors in accordance with International Committee of Medical Journal Editors criteria for authorship.
Disclaimer The authors are guarantors of this document, which expresses the opinions and conclusions of the authors and not those of their corresponding affiliations.
Competing interests DN received a fellowship grant from electroCore. OE participated in a clinical study supported by electroCore. JM has participated in clinical trials supported by electroCore. EL is an employee of electroCore and receives stock ownership.
Ethics approval New Devices Committee at the Royal Free London NHS Foundation Trust.
Provenance and peer review Not commissioned; externally peer reviewed.