Effect of Transcutaneous Vagal Nerve Stimulation on Reducing Visually Induced Motion Sickness in Healthy Volunteers

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Visually Induced Motion Sickness in Healthy Volunteers	Device: Transcutaneous vagal nerve stimulation; Device: Sham vagal nerve stimulation	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	25 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Effect of Transcutaneous Vagal Nerve Stimulation on Reducing Visually Induced Motion Sickness in Healthy Volunteers
Study Start Date :	November 2014
Actual Primary Completion Date :	November 2015
Actual Study Completion Date :	November 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Transcutaneous vagal nerve stimulation; Active vagal nerve stimulation to the left auricular branch of the vagus nerve	Device: Transcutaneous vagal nerve stimulation; Other Name: NEMOS
Placebo Comparator: Sham 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

Outcome Measures

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Primary Outcome Measures :

1. Reduction of the subjective sensation of nausea on a visual analogue scale [ Time Frame: 10 minutes ]

Secondary Outcome Measures :

1. Effect of transcutaneous vagal nerve stimulation on cardiac vagal tone [ Time Frame: 10 minutes ]
2. Tolerability of transcutaneous vagal nerve stimulation [ Time Frame: 10 minutes ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

1. Healthy subjects, aged 18-65, from staff, students and local population of Queen Mary, University of London.
2. Inclusion will be determined on the basis of availability, with no prior selection bias included. They should be able to attend the Wingate Institute for at least 2 x 1 hour sessions.
3. Subjects who score >15 on MSSQ (suggesting that they are sensitive to visually induced nausea).

Exclusion Criteria:

1. Subjects unable to provide informed consent.
2. Subjects with any systemic disease or medications that may influence the autonomic nervous system (e.g. beta-agonists or Parkinson's disease).
3. Subjects who score <15 on MSSQ (suggesting that they are insensitive to visually induced nausea).
4. Pregnant females to prevent any confounding effects on pregnancy related nausea.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United Kingdom
Wingate Institute of Neurogastroenterology
London, United Kingdom, E1 @AJ

Sponsors and Collaborators

Wingate Institute of Neurogastroenterology

Investigators

Principal Investigator:	Adam D Farmer, PhD MRCP	Wingate Institute

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Vagal nerve stimulator information 

Publications:

Farmer AD, Al Omran Y, Aziz Q, Andrews PL. The role of the parasympathetic nervous system in visually induced motion sickness: systematic review and meta-analysis. Exp Brain Res. 2014 Aug;232(8):2665-73. doi: 10.1007/s00221-014-3964-3. Epub 2014 May 4. Review.

Responsible Party:	Adam Farmer, Research fellow, Wingate Institute of Neurogastroenterology
ClinicalTrials.gov Identifier:	NCT02177890 History of Changes
Other Study ID Numbers:	1-Farmer
First Posted:	June 30, 2014
Last Update Posted:	December 2, 2015
Last Verified:	November 2015

Additional relevant MeSH terms:

Motion Sickness; Signs and Symptoms