Visually Induced Motion Sickness in Healthy VolunteersNCT02177890
Effect of Transcutaneous Vagal Nerve Stimulation on Reducing Visually Induced Motion Sickness in Healthy Volunteers
A study testing Transcutaneous vagal nerve stimulation in people with Visually Induced Motion Sickness in Healthy Volunteers, run by Wingate Institute of Neurogastroenterology at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Visually Induced Motion Sickness in Healthy Volunteers
- What is being tested?
- Transcutaneous vagal nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2014to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Wingate Institute of Neurogastroenterology
London, London, E1 @AJ
About this study
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.
- Being tested
- Transcutaneous vagal nerve stimulation, Sham vagal nerve stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous vagal nerve stimulationDevice
Also called NEMOS
Sham vagal nerve stimulationDevice
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous vagal nerve stimulation | Experimental | Active vagal nerve stimulation to the left auricular branch of the vagus nerve Receives: 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. Receives: Device: Sham vagal nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of the subjective sensation of nausea on a visual analogue scale
Measured: 10 minutes
Secondary outcomes (2)
Effect of transcutaneous vagal nerve stimulation on cardiac vagal tone
Measured: 10 minutes
Tolerability of transcutaneous vagal nerve stimulation
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Visually Induced Motion Sickness in Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wingate Institute of Neurogastroenterology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Farmer, Wingate Institute of Neurogastroenterology
- Investigators
- Adam D Farmer, PhD MRCP, Principal investigator, Wingate Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02177890
- Sponsor's protocol ID
- 1-Farmer
- Status last verified
- Nov 2015
- First submitted
- 24 Jun 2014
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24792503
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Vagal Nerve Stimulation on Reducing Visually Induced Motion Sickness in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02177890
- Acronym / sponsor ID
- 1-Farmer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Wingate Institute of NeurogastroenterologyUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 30 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous vagal nerve stimulation | Experimental | Device: Transcutaneous vagal nerve stimulationActive vagal nerve stimulation to the left auricular branch of the vagus nerve |
| Sham vagal nerve stimulation | Placebo comparator | Device: Sham vagal nerve stimulationPlacebo vagal nerve stimulation - stimulator attached to the ear but rotated 180 degrees so that it is not stimulating the vagus nerve. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous vagal nerve stimulationAlso: NEMOS | Device | Transcutaneous vagal nerve stimulation |
| Sham vagal nerve stimulation | Device | Sham vagal nerve stimulation |
Primary outcome
Reduction of the subjective sensation of nausea on a visual analogue scale
Time frame: 10 minutes
2 secondary outcomes
Effect of transcutaneous vagal nerve stimulation on cardiac vagal tone
Time frame: 10 minutes
Tolerability of transcutaneous vagal nerve stimulation
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
- Background: PubMed 24792503Farmer 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.
- Vagal nerve stimulator informationLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam D Farmer, PhD MRCP principal investigator
Wingate Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous vagal nerve stimulation in people with Visually Induced Motion Sickness in Healthy Volunteers, run by Wingate Institute of Neurogastroenterology at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of the subjective sensation of nausea on a visual analogue scale (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02177890, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.