NCT02177890

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 30, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

1 year

First QC Date

June 24, 2014

Last Update Submit

November 30, 2015

Conditions

Visually Induced Motion Sickness in Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Reduction of the subjective sensation of nausea on a visual analogue scale

    10 minutes

Secondary Outcomes (2)

  • Effect of transcutaneous vagal nerve stimulation on cardiac vagal tone

    10 minutes

  • Tolerability of transcutaneous vagal nerve stimulation

    10 minutes

Study Arms (2)

Transcutaneous vagal nerve stimulation

EXPERIMENTAL

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

Device: Transcutaneous vagal nerve stimulation

Sham vagal nerve stimulation

PLACEBO COMPARATOR

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

Interventions

Transcutaneous vagal nerve stimulationDEVICE
Also known as: NEMOS
Transcutaneous vagal nerve stimulation
Sham vagal nerve stimulationDEVICE
Sham vagal nerve stimulation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wingate Institute of Neurogastroenterology

London, London, E1 @AJ, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 24792503BACKGROUND

Related Links

Study Officials

  • Adam D Farmer, PhD MRCP

    Wingate Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research fellow

Study Record Dates

First Submitted

June 24, 2014

First Posted

June 30, 2014

Study Start

November 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations

GB(1)