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OpenTrials
Completed

NCT Number: NCT02177890

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wingate Institute of Neurogastroenterology

London, E1 @AJ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy subjects, aged 18-65, from staff, students and local population of Queen Mary, University of London.
  • 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.
  • Subjects who score >15 on MSSQ (suggesting that they are sensitive to visually induced nausea).

Exclusion criteria

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

Treatment and study plan

transcutaneous vagal nerve stimulation

Device

Other names: NEMOS

Sham vagal nerve stimulation

Device

Primary outcomes

  1. Reduction of the subjective sensation of nausea on a visual analogue scale

    Time frame: 10 minutes

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Wingate Institute of Neurogastroenterology

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 30, 2014
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.