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. 2017 Oct;8(4):325-330.
doi: 10.1136/flgastro-2017-100809. Epub 2017 May 24.

Proof of concept: short-term non-invasive cervical vagus nerve stimulation in patients with drug-refractory gastroparesis

Emma Paulon  1 , Despoina Nastou  1 , Francesca Jaboli  1 , Juana Marin  2 , Eric Liebler  3 , Owen Epstein  1
Affiliations

Proof of concept: short-term non-invasive cervical vagus nerve stimulation in patients with drug-refractory gastroparesis

Emma Paulon et al. Frontline Gastroenterol. 2017 Oct.

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.

Keywords: AUTONOMIC NERVOUS SYSTEM; GASTROPARESIS; NERVE - GUT INTERACTIONS.

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Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Positioning of the non-invasive vagus nerve stimulation device. Image provided courtesy of electroCore.
Figure 2
Figure 2
Mean aggregate Gastroparesis Cardinal Symptom Index (GCSI )scores in all patients (n=23) and responders (n=10).
Figure 3
Figure 3
Percentage change in mean subscale score for nausea/vomiting (A), postprandial fullness/early satiety (B) and bloating (C) for all patients (n=23) and responders (n=10).
See this image and copyright information in PMC

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