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

Primary Purpose

Visually Induced Motion Sickness in Healthy Volunteers

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Transcutaneous vagal nerve stimulation
Sham vagal nerve stimulation
Sponsored by
Wingate Institute of Neurogastroenterology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Visually Induced Motion Sickness in Healthy Volunteers

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Wingate Institute of Neurogastroenterology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Transcutaneous vagal nerve stimulation

Sham vagal nerve stimulation

Arm Description

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

Placebo vagal nerve stimulation - stimulator attached to the ear but rotated 180 degrees so that it is not stimulating the vagus nerve.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Effect of transcutaneous vagal nerve stimulation on cardiac vagal tone
Tolerability of transcutaneous vagal nerve stimulation

Full Information

First Posted
June 24, 2014
Last Updated
November 30, 2015
Sponsor
Wingate Institute of Neurogastroenterology
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1. Study Identification

Unique Protocol Identification Number
NCT02177890
Brief Title
Effect of Transcutaneous Vagal Nerve Stimulation on Reducing Visually Induced Motion Sickness in Healthy Volunteers
Official Title
Effect of Transcutaneous Vagal Nerve Stimulation on Reducing Visually Induced Motion Sickness in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wingate Institute of Neurogastroenterology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visually Induced Motion Sickness in Healthy Volunteers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcutaneous vagal nerve stimulation
Arm Type
Experimental
Arm Description
Active vagal nerve stimulation to the left auricular branch of the vagus nerve
Arm Title
Sham vagal nerve stimulation
Arm Type
Placebo Comparator
Arm Description
Placebo vagal nerve stimulation - stimulator attached to the ear but rotated 180 degrees so that it is not stimulating the vagus nerve.
Intervention Type
Device
Intervention Name(s)
Transcutaneous vagal nerve stimulation
Other Intervention Name(s)
NEMOS
Intervention Type
Device
Intervention Name(s)
Sham vagal nerve stimulation
Primary Outcome Measure Information:
Title
Reduction of the subjective sensation of nausea on a visual analogue scale
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Effect of transcutaneous vagal nerve stimulation on cardiac vagal tone
Time Frame
10 minutes
Title
Tolerability of transcutaneous vagal nerve stimulation
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam D Farmer, PhD MRCP
Organizational Affiliation
Wingate Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wingate Institute of Neurogastroenterology
City
London
ZIP/Postal Code
E1 @AJ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24792503
Citation
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.
Results Reference
background
Links:
URL
http://www.cerbomed.com/
Description
Vagal nerve stimulator information

Learn more about this trial

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

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