Chronic NauseaVAMOSNCT07873164
Vagal Auricular Stimulation for Motion Sickness
A study testing UROStim in people with Chronic Nausea, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial summary
This study aims to understand the mechanisms underlying nausea response in the brain stem, and the effect of vagal nerve stimulation on nausea. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Nausea
- What is being tested?
- UROStim
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2027to 24 Sep 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65 years old (inclusive)
- Ability to give written consent and participate in behavioral intervention in English
- Avoidance of alcohol, nicotine, and caffeine for 24 hours prior to study session
- Motion Sickness Susceptibility Questionnaire (MSSQ) percentile score > 60.
- Adequate visual, hearing, cognitive, and physical ability
Who cannot join
- Chronic nausea due to medications or gastrointestinal conditions
- Prior or current history of seizures
- Severe autonomic dysfunction
- No active clinical acupuncture therapy
- History of arrhythmias
- Endorses any contraindications to MRI
Show all 17Show fewer
- Body weight of 450 lbs or greater or BMI of 32 kg/m2 or greater (limit of MRI table)
- History any serious medical condition (e.g., cancer)
- Pregnancy/breastfeeding within the last 8 weeks
- Uncontrolled diabetes (indicated by HbA1c ³ 7%) by chart
- Narcotic analgesics greater than three days per week
- Illicit drugs or opioid usage
- Cannabinoid use greater than three days per week
- Intellectual disability by history
- Illiteracy
- Inability to provide informed consent
- Any other condition interfering with study requirements, according to the investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Spaulding Rehabilitation Hospital, 300 First Avenue
Boston, Massachusetts, 02129
Luca McKerley Coronado, (857) 238-0962, mghvamosstudy@mgb.org
About this study
Official title: Central Mechanisms of Nausea and Their Modulation Via Non-invasive Neurostimulation
This study aims to understand the mechanisms underlying nausea response in the brain stem, and the effect of vagal nerve stimulation on nausea.
- Conditions
- Chronic Nausea
- Being tested
- UROStim
- Keywords
- Motion Sickness, Nausea, MRI
- Medical subject headings
- Motion Sickness, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UROStimDevice
MRI safe vagal nerve stimulation during motion sickness inducing paradigm.
| Study group | Role | What they receive |
|---|---|---|
| Visit 1: Active stimulation; Visit 2: Sham stimulation | Experimental | This group will receive active stimulation during the motion sickness paradigm of the first MRI, and sham stimulation during the motion sickness paradigm of the second MRI. Receives: Device: UROStim |
| Visit 1: Sham stimulation; Visit 2: Active Stimulation | Experimental | This group will receive sham stimulation during the motion sickness paradigm of the first MRI, and active stimulation during the motion sickness paradigm of the second MRI. Receives: Device: UROStim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simulator Sickness Questionnaire (SSQ), Nausea subscale
0 (not at all) is the minimum, 3 (severe) is the maximum. Higher scores mean a worse outcome: a higher score means the participant reported more nausea symptoms.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start24 Sep 2027 (estimated)
- Primary completion24 Sep 2030 (estimated)
- Study completion24 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic NauseaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Roberta Sclocco, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873164
- Sponsor's protocol ID
- 2026P002811
- Other IDs
- R01AT014133
- Acronym
- VAMOS
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Mechanisms of Nausea and Their Modulation Via Non-invasive Neurostimulation
- ClinicalTrials.gov ID
- NCT07873164
- Acronym / sponsor ID
- VAMOS / 2026P002811
- Conditions
- Chronic Nausea
- Keywords
- Motion Sickness, Nausea, MRI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 24 Sep 2027 (estimated)
- Primary completion
- 24 Sep 2030 (estimated)
- Study completion
- 24 Sep 2031 (estimated)
- First posted
- 14 Oct 2026 (actual)
- 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.
This study aims to understand the mechanisms underlying nausea response in the brain stem, and the effect of vagal nerve stimulation on nausea.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visit 1: Active stimulation; Visit 2: Sham stimulation | Experimental | Device: UROStimThis group will receive active stimulation during the motion sickness paradigm of the first MRI, and sham stimulation during the motion sickness paradigm of the second MRI. |
| Visit 1: Sham stimulation; Visit 2: Active Stimulation | Experimental | Device: UROStimThis group will receive sham stimulation during the motion sickness paradigm of the first MRI, and active stimulation during the motion sickness paradigm of the second MRI. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-65 years old (inclusive)
- Ability to give written consent and participate in behavioral intervention in English
- Avoidance of alcohol, nicotine, and caffeine for 24 hours prior to study session
- Motion Sickness Susceptibility Questionnaire (MSSQ) percentile score > 60.
- Adequate visual, hearing, cognitive, and physical ability
Key exclusion criteria (17 listed)
- Chronic nausea due to medications or gastrointestinal conditions
- Prior or current history of seizures
- Severe autonomic dysfunction
- No active clinical acupuncture therapy
- History of arrhythmias
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 |
|---|---|---|
| UROStimMRI safe vagal nerve stimulation during motion sickness inducing paradigm. | Device | Visit 1: Active stimulation; Visit 2: Sham stimulation, Visit 1: Sham stimulation; Visit 2: Active Stimulation |
Primary outcome
Simulator Sickness Questionnaire (SSQ), Nausea subscale
Time frame: 2 hours
0 (not at all) is the minimum, 3 (severe) is the maximum. Higher scores mean a worse outcome: a higher score means the participant reported more nausea symptoms.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UROStim in people with Chronic Nausea, run by Spaulding Rehabilitation Hospital at 1 site in United States.
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 5 inclusion and 17 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: opening soon, as of the sponsor's last update on 16 Oct 2026. 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 States. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luca McKerley Coronado, BA ((857) 238-0962, mghvamosstudy@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Simulator Sickness Questionnaire (SSQ), Nausea subscale (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2026.