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

NCT ID: NCT02177890

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Visually Induced Motion Sickness in Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Transcutaneous vagal nerve stimulation

Active vagal nerve stimulation to the left auricular branch of the vagus nerve

Group Type EXPERIMENTAL

Transcutaneous vagal nerve stimulation

Intervention Type DEVICE

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.

Group Type PLACEBO_COMPARATOR

Sham vagal nerve stimulation

Intervention Type DEVICE

Interventions

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Transcutaneous vagal nerve stimulation

Intervention Type DEVICE

Sham vagal nerve stimulation

Intervention Type DEVICE

Other Intervention Names

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NEMOS

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wingate Institute of Neurogastroenterology

OTHER

Sponsor Role lead

Responsible Party

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Adam Farmer

Research fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adam D Farmer, PhD MRCP

Role: PRINCIPAL_INVESTIGATOR

Wingate Institute

Locations

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Wingate Institute of Neurogastroenterology

London, London, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 24792503 (View on PubMed)

Related Links

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http://www.cerbomed.com/

Vagal nerve stimulator information

Other Identifiers

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1-Farmer

Identifier Type: -

Identifier Source: org_study_id