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

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ClinicalTrials.gov Identifier: NCT02177890
Recruitment Status : Completed
First Posted : June 30, 2014
Last Update Posted : December 2, 2015
Sponsor:
Information provided by (Responsible Party):
Adam Farmer, Wingate Institute of Neurogastroenterology

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

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Arms and Interventions
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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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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02177890


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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Additional Information:
Vagal nerve stimulator information  This link exits the ClinicalTrials.gov site

Publications:

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    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Motion Sickness
Signs and Symptoms