Effect of transcutaneous vagus nerve stimulation on muscle activity in the gastrointestinal tract (transVaGa): a prospective clinical trial
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Postoperative ileus (POI) is a common complication after abdominal surgery. Invasive stimulation of the cervical vagus nerve is known to reduce inflammatory response and ameliorated POI after surgery in a mouse model. However, the transcutaneous vagus nerve stimulation (tVNS) is a possible non-invasive approach. In this clinical study, we aimed to investigate the effect of tVNS on the activation of the stomach muscle in humans.
Patients requiring open laparotomy were screened for this prospective proof of concept clinical study. After open laparotomy, muscle activity of the stomach was measured by a free running electromyography (EMG) before and during tVNS on the ear. Frequency and amplitude of compound gastric action potentials were the electrophysiological parameters we assessed to reveal the changes in electro motor gastric activity. Gastrin levels as a surrogate marker for vagus nerve activation was analyzed before, 1 and 3 h after tVNS.
Fourteen patients were included, no severe adverse events and no medical device related adverse events occurred. tVNS led to significant reduction of action potential frequency and significant elevation of action potential amplitude in the stomach compared to control. Gastrin levels were significantly elevated 3 h after tVNS compared to levels before tVNS.
Application of tVNS is a safe and feasible procedure during surgical intervention. Our results provide evidence that tVNS activates efferent visceral vagal fibers. Therefore, this low risk and easy to perform method could be useful to prevent postoperative ileus.
Clinical trial register number
KeywordsTranscutaneous vagus nerve stimulation Neurogastroenterology Postoperative ileus Clinical trial
We thank Inomed for providing us with the ISIS IOM System®, especially Mrs. C. Wegner for her technical support. We also thank Mrs. Warnken Uhlich and Uta Wolber from the Study Center Bonn.
This study was supported by a grant from BONFOR (grant number: O-112.0059.1) to GH.
Compliance with ethical standards
Conflicts of interest
GH received research grant support by PlantTec Medical GmbHSW and JCK received royalties from Wolters Kluwer for writing articles about POI in UpToDate® resource tool.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standard. The study was approved by the federal institute for Drugs and Medical Devices (BfArM) (CIV-1504-013367) and the local ethical board (179/15-MPG).
Informed consent was obtained from all individual participants included in the study.
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