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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Adam Farmer, Wingate Institute of Neurogastroenterology
ClinicalTrials.gov Identifier:
NCT02177890
First received: June 24, 2014
Last updated: November 30, 2015
Last verified: November 2015
  Purpose
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 Intervention
Visually Induced Motion Sickness in Healthy Volunteers Device: Transcutaneous vagal nerve stimulation Device: Sham vagal nerve stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Transcutaneous Vagal Nerve Stimulation on Reducing Visually Induced Motion Sickness in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Adam Farmer, Wingate Institute of Neurogastroenterology:

Primary Outcome Measures:
  • Reduction of the subjective sensation of nausea on a visual analogue scale [ Time Frame: 10 minutes ]

Secondary Outcome Measures:
  • Effect of transcutaneous vagal nerve stimulation on cardiac vagal tone [ Time Frame: 10 minutes ]
  • Tolerability of transcutaneous vagal nerve stimulation [ Time Frame: 10 minutes ]

Enrollment: 25
Study Start Date: November 2014
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
Publications:
Responsible Party: Adam Farmer, Research fellow, Wingate Institute of Neurogastroenterology
ClinicalTrials.gov Identifier: NCT02177890     History of Changes
Other Study ID Numbers: 1-Farmer
Study First Received: June 24, 2014
Last Updated: November 30, 2015

Additional relevant MeSH terms:
Motion Sickness
Signs and Symptoms

ClinicalTrials.gov processed this record on June 27, 2017