Journal
FRONTLINE GASTROENTEROLOGY
Volume 8, Issue 4, Pages 325-330Publisher
BMJ PUBLISHING GROUP
DOI: 10.1136/flgastro-2017-100809
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Funding
- electroCore
- electroCore, Basking Ridge, New Jersey
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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.& para;& para;Objective This open-label proof-of-concept study assessed the effects of nVNS in patients with severe drug-refractory gastroparesis.& para;& para;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.& para;& para;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.& para;& para;Conclusions These preliminary results provide a signal that nVNS may be useful for treating refractory gastroparesis. Larger controlled studies are warranted.
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