An interventional study of Transcutaneous vagal nerve stimulation and Sham vagal nerve stimulation in Visually Induced Motion Sickness in Healthy Volunteers, sponsored by Wingate Institute of Neurogastroenterology. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-02.
Sponsored by Wingate Institute of Neurogastroenterology · Not applicable, Interventional, and Treatment
Nausea is a common and distressing experience that often precedes vomiting. Amongst symptoms emanating from the gastrointestinal (GI) tract nausea can be considered somewhat unique, as on one hand it represents a normal, highly conserved, physiological response to an ingested toxin yet on the other it may indicate pathology. Nausea may also arise as a consequence of pharmaco- and chemotherapeutic interventions. Nausea negatively impacts on quality of life, adherence to treatment and is a cause for discontinuation of the development of novel compounds. Experimentally, nausea can be induced in humans using a visually induced motion stimulus. Previously we have developed a 10-minute motion video of the landscape rotating as seen from the perspective of a subject standing on Westminster Bridge, London. The tilted and rotating view visual display makes the subject perceive that they are spinning round and round on a spot tilted away from centre of gravity due to circular vection. This motion video induced nausea in approximately 50% of healthy participants and caused a reduction in cardiac vagal tone, a validated measure of the parasympathetic nervous system branch on the autonomic nervous system. We therefore are evaluating the role of external transcutaneous vagal nerve stimulation in visually induced motion sickness.
50 studies on the registry are indexed under Motion Sickness; 9 are open to participants now.
This study's enrollment of 25 is below the median of 59 across 44 interventional studies indexed under Motion Sickness.
Browse Motion Sickness studies →Wingate Institute of Neurogastroenterology is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Active vagal nerve stimulation to the left auricular branch of the vagus nerve
Device: Transcutaneous vagal nerve stimulation
Placebo vagal nerve stimulation - stimulator attached to the ear but rotated 180 degrees so that it is not stimulating the vagus nerve.
Device: Sham vagal nerve stimulation
Also known as: NEMOS
Reduction of the subjective sensation of nausea on a visual analogue scale
Time frame: 10 minutes
Effect of transcutaneous vagal nerve stimulation on cardiac vagal tone
Time frame: 10 minutes
Tolerability of transcutaneous vagal nerve stimulation
Time frame: 10 minutes
The record gives a start of Nov 2014, a primary completion of Nov 2015 and a completion of Nov 2015. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Wingate Institute of Neurogastroenterology