VertigoNCT06062368
Reducing Vertigo Associated With MRI Machines
A study testing Rate of Entry in people with Vertigo and Dizziness, run by Johns Hopkins University at 1 site in United States.
Trial summary
Vertigo, dizziness, and imbalance are commonly reported by patients and technologists when near high-field strength magnets (>4 Tesla, T) used for magnetic resonance imaging (MRI) (1-5) Prior research from the investigators has established that the mechanism is likely a Lorentz force occurring in the inner ear, as a… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Rate of Entry
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2024to 1 Jan 2028
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants who will be undergoing an MRI scan at a 7 Tesla MRI.
Who cannot join
- Exclusion criteria include pacemaker, defibrillator wires, metal implants, cochlear implants, or ferromagnetic surgical clips in the brain.
- Pregnancy
- Claustrophobia occurs in perhaps 5% of patients, and they will not proceed with the test. All subjects will fill out the routine pretesting MRI questionnaire.
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, 1 recruiting
- Recruiting
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
Bryan K Ward, MD, 443-997-6467, bryan.k.ward@gmail.com
Adrian Paez, BA, 443-923-9200, paez@kennedykrieger.org
About this study
Vertigo, dizziness, and imbalance are commonly reported by patients and technologists when near high-field strength magnets (>4 Tesla, T) used for magnetic resonance imaging (MRI) (1-5) Prior research from the investigators has established that the mechanism is likely a Lorentz force occurring in the inner ear, as a result of interactions with normal electrical currents in the inner ear and the strong static magnetic field of the MRI machine. The investigators have recently developed preliminary data to suggest that slower rates of entry into the magnetic field can greatly attenuate the sensations of vertigo. The explanation for this is that the rates of vestibular adaptation exceed that of the stimulus, allowed a reduction or elimination of the symptoms of vertigo. The aim of this study is to recruit individuals who are already getting an MRI scan as part of other research studies to randomize the rate of entry into and exit from the static magnetic field (i.e., before and after imaging is performed). The usual rate of entry is 20 seconds. This will be increased to one, two or three minutes. The investigators will record subjective sensations of dizziness and vertigo associated with the entry into the MRI.
Read the detailed description
Vertigo and nystagmus are commonly reported in 7 Tesla MRI machines, in upwards of 2/3 of individuals. Magnetic vestibular stimulation (MVS) of the inner ear explains these symptoms. In the normal state, the inner ear has constant electric current flowing from the dark cells to the hair cells of the utricular macula through the potassium enriched endolymph. This electric current drives the utricle's exquisitely sensitive response to linear accelerations. Near the utricular macula are the cupulae of the lateral and superior semicircular canals (SCCs), which are exquisitely sensitive to angular accelerations. Inside an MRI scanner, the electric current entering the utricular macula in each ear interacts with the MRI static magnetic field to create a Lorentz (magneto-hydrodynamic (MHD) force in the endolymph that pushes on the cupulae of the nearby lateral and superior semicircular canals. The force scales linearly with magnetic field strength. Thus, when a human with an intact vestibular system lies in a 7 T MRI magnet, the Lorenz force causes the endolymph to push on the cupulae, changing activity of the angular vestibulo-ocular reflex (VOR) pathway, generating both a transient sensation of motion and a sustained beating of the eyes (nystagmus), with alternating slow phases from the VOR and quick phases that reset the position of the eye.
Adult individuals that are undergoing a 7 Tesla MRI as part of other research protocols at Kennedy-Krieger Kirby Institute, will be recruited. The usual entry into the magnetic field is a button that is pressed, that enters the magnetic field over 20 seconds, and exits the magnetic field over 20 seconds. Each participant will be randomized to one of four groups: 1) entering/exiting at the usual 20 seconds, 2) entering/exiting over 1 minute, 3) entering/exiting over 2 minutes, or 4) entering/exiting over 3 minutes. Participants will be asked to close the eyes during entry and exit. The onset of vertigo and description of the sensation will be recorded. At 15 second intervals, the participants will be asked to rate vertigo on a scale from 0 (no vertigo) to 3 (severe vertigo). The end time of vertigo sensations will also be recorded. The same procedure will be completed when exiting the MRI scan.
- Being tested
- Rate of Entry
- Keywords
- MRI, 7 Tesla, Magnetic Vestibular Stimulation
- Medical subject headings
- Vertigo, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rate of EntryBehavioural
The participant will enter and exit the MRI scan at a slower rate than the manufacturer entry and exit.
| Study group | Role | What they receive |
|---|---|---|
| Standard Duration | No intervention | The participant will undergo an MRI scan using the manufacturer's rate of entry into and exit from the MRI machine. This rate of entry and exit is 20 seconds. |
| 1-minute entry | Experimental | The participant will undergo an MRI scan using a slower rate of entry than that specified by the manufacturer. This rate of entry is one minute (60 seconds). Receives: Behavioral: Rate of Entry |
| 2-minute entry | Experimental | The participant will undergo an MRI scan using a slower rate of entry than that specified by the manufacturer. This rate of entry is two minutes (120 seconds). Receives: Behavioral: Rate of Entry |
| 3-minute entry | Experimental | The participant will undergo an MRI scan using a slower rate of entry than that specified by the manufacturer. This rate of entry is three minutes (180 seconds). Receives: Behavioral: Rate of Entry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of vertigo symptoms
Participants will report the presence and intensity of their vertigo. The presence or absence of vertigo for each group will be the primary outcome.
Measured: During MRI up to 6 minutes
Secondary outcomes (2)
Intensity of Vertigo
Participants will report the intensity of their vertigo symptoms when entering and exiting the MRI scan on a scale from 0 (no vertigo)-3 (severe vertigo) at 15 second intervals. 0=no vertigo, 1=mild vertigo, 2=moderate vertigo, 3=severe vertigo
Measured: During MRI up to 6 minutes
Duration (seconds) of Vertigo
Participants will report the onset and cessation of their vertigo symptoms when entering and exiting the MRI scanner. The duration will be calculated in seconds.
Measured: During MRI up to 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start15 Jan 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for VertigoStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individuals will be randomized to one of four groups, each with a different rate of entry into and exit out of the 7 Tesla MRI machine.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Bryan Ward, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062368
- Sponsor's protocol ID
- IRB00413291
- Other IDs
- K23DC018302
- Status last verified
- Nov 2025
- First submitted
- 25 Sep 2023
- Last updated
- 12 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will be used only by the investigators participating in this study at Johns Hopkins University School of Medicine.
Publications
Mian OS, Li Y, Antunes A, Glover PM, Day BL. Effect of head pitch and roll orientations on magnetically induced vertigo. J Physiol. 2016 Feb 15;594(4):1051-67. doi: 10.1113/JP271513. Epub 2015 Dec 30.
PubMed 26614577Mian OS, Li Y, Antunes A, Glover PM, Day BL. On the vertigo due to static magnetic fields. PLoS One. 2013 Oct 30;8(10):e78748. doi: 10.1371/journal.pone.0078748. eCollection 2013.
PubMed 24205304Roberts DC, Marcelli V, Gillen JS, Carey JP, Della Santina CC, Zee DS. MRI magnetic field stimulates rotational sensors of the brain. Curr Biol. 2011 Oct 11;21(19):1635-40. doi: 10.1016/j.cub.2011.08.029. Epub 2011 Sep 22.
PubMed 21945276Ward BK, Roberts DC, Otero-Millan J, Zee DS. A decade of magnetic vestibular stimulation: from serendipity to physics to the clinic. J Neurophysiol. 2019 Jun 1;121(6):2013-2019. doi: 10.1152/jn.00873.2018. Epub 2019 Apr 10.
PubMed 30969883
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Vertigo Associated With MRI Machines
- ClinicalTrials.gov ID
- NCT06062368
- Acronym / sponsor ID
- IRB00413291
- Keywords
- MRI, 7 Tesla, Magnetic Vestibular Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 2 Oct 2023 (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.
Vertigo, dizziness, and imbalance are commonly reported by patients and technologists when near high-field strength magnets (>4 Tesla, T) used for magnetic resonance imaging (MRI) (1-5) Prior research from the investigators has established that the mechanism is likely a Lorentz force occurring in the inner ear, as a result of interactions with normal electrical currents in the inner ear and the strong static magnetic field of the MRI machine. The investigators have recently developed preliminary data to suggest that slower rates of entry into the magnetic field can greatly attenuate the sensations of vertigo. The explanation for this is that the rates of vestibular adaptation exceed that of the stimulus, allowed a reduction or elimination of the symptoms of vertigo. The aim of this study is to recruit individuals who are already getting an MRI scan as part of other research studies to randomize the rate of entry into and exit from the static magnetic field (i.e., before and after imaging is performed). The usual rate of entry is 20 seconds. This will be increased to one, two or three minutes. The investigators will record subjective sensations of dizziness and vertigo associated with the entry into the MRI.
Detailed description
Vertigo and nystagmus are commonly reported in 7 Tesla MRI machines, in upwards of 2/3 of individuals. Magnetic vestibular stimulation (MVS) of the inner ear explains these symptoms. In the normal state, the inner ear has constant electric current flowing from the dark cells to the hair cells of the utricular macula through the potassium enriched endolymph. This electric current drives the utricle's exquisitely sensitive response to linear accelerations. Near the utricular macula are the cupulae of the lateral and superior semicircular canals (SCCs), which are exquisitely sensitive to angular accelerations. Inside an MRI scanner, the electric current entering the utricular macula in each ear interacts with the MRI static magnetic field to create a Lorentz (magneto-hydrodynamic (MHD) force in the endolymph that pushes on the cupulae of the nearby lateral and superior semicircular canals. The force scales linearly with magnetic field strength. Thus, when a human with an intact vestibular system lies in a 7 T MRI magnet, the Lorenz force causes the endolymph to push on the cupulae, changing activity of the angular vestibulo-ocular reflex (VOR) pathway, generating both a transient sensation of motion and a sustained beating of the eyes (nystagmus), with alternating slow phases from the VOR and quick phases that reset the position of the eye.
Adult individuals that are undergoing a 7 Tesla MRI as part of other research protocols at Kennedy-Krieger Kirby Institute, will be recruited. The usual entry into the magnetic field is a button that is pressed, that enters the magnetic field over 20 seconds, and exits the magnetic field over 20 seconds. Each participant will be randomized to one of four groups: 1) entering/exiting at the usual 20 seconds, 2) entering/exiting over 1 minute, 3) entering/exiting over 2 minutes, or 4) entering/exiting over 3 minutes. Participants will be asked to close the eyes during entry and exit. The onset of vertigo and description of the sensation will be recorded. At 15 second intervals, the participants will be asked to rate vertigo on a scale from 0 (no vertigo) to 3 (severe vertigo). The end time of vertigo sensations will also be recorded. The same procedure will be completed when exiting the MRI scan.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Individuals will be randomized to one of four groups, each with a different rate of entry into and exit out of the 7 Tesla MRI machine.
| Arm | Type | Receives |
|---|---|---|
| Standard Duration | No intervention | –The participant will undergo an MRI scan using the manufacturer's rate of entry into and exit from the MRI machine. This rate of entry and exit is 20 seconds. |
| 1-minute entry | Experimental | Behavioral: Rate of EntryThe participant will undergo an MRI scan using a slower rate of entry than that specified by the manufacturer. This rate of entry is one minute (60 seconds). |
| 2-minute entry | Experimental | Behavioral: Rate of EntryThe participant will undergo an MRI scan using a slower rate of entry than that specified by the manufacturer. This rate of entry is two minutes (120 seconds). |
| 3-minute entry | Experimental | Behavioral: Rate of EntryThe participant will undergo an MRI scan using a slower rate of entry than that specified by the manufacturer. This rate of entry is three minutes (180 seconds). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants who will be undergoing an MRI scan at a 7 Tesla MRI.
Key exclusion criteria (3 listed)
- Exclusion criteria include pacemaker, defibrillator wires, metal implants, cochlear implants, or ferromagnetic surgical clips in the brain.
- Pregnancy
- Claustrophobia occurs in perhaps 5% of patients, and they will not proceed with the test. All subjects will fill out the routine pretesting MRI questionnaire.
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 |
|---|---|---|
| Rate of EntryThe participant will enter and exit the MRI scan at a slower rate than the manufacturer entry and exit. | Behavioural | 1-minute entry, 2-minute entry, 3-minute entry |
Primary outcome
Prevalence of vertigo symptoms
Time frame: During MRI up to 6 minutes
Participants will report the presence and intensity of their vertigo. The presence or absence of vertigo for each group will be the primary outcome.
2 secondary outcomes
Intensity of Vertigo
Time frame: During MRI up to 6 minutes
Duration (seconds) of Vertigo
Time frame: During MRI up to 6 minutes
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 12 Nov 2025.
- Background: PubMed 26614577Mian OS, Li Y, Antunes A, Glover PM, Day BL. Effect of head pitch and roll orientations on magnetically induced vertigo. J Physiol. 2016 Feb 15;594(4):1051-67. doi: 10.1113/JP271513. Epub 2015 Dec 30.
- Background: PubMed 24205304Mian OS, Li Y, Antunes A, Glover PM, Day BL. On the vertigo due to static magnetic fields. PLoS One. 2013 Oct 30;8(10):e78748. doi: 10.1371/journal.pone.0078748. eCollection 2013.
- Background: PubMed 21945276Roberts DC, Marcelli V, Gillen JS, Carey JP, Della Santina CC, Zee DS. MRI magnetic field stimulates rotational sensors of the brain. Curr Biol. 2011 Oct 11;21(19):1635-40. doi: 10.1016/j.cub.2011.08.029. Epub 2011 Sep 22.
- Results publication: PubMed 30969883Ward BK, Roberts DC, Otero-Millan J, Zee DS. A decade of magnetic vestibular stimulation: from serendipity to physics to the clinic. J Neurophysiol. 2019 Jun 1;121(6):2013-2019. doi: 10.1152/jn.00873.2018. Epub 2019 Apr 10.
- Individual participant dataSharing planned: No. Individual participant data will be used only by the investigators participating in this study at Johns Hopkins University School of Medicine.
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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.
Bryan Ward, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rate of Entry in people with Vertigo and Dizziness, run by Johns Hopkins University 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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 12 Nov 2025. 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 Bryan K Ward, MD (443-997-6467, bryan.k.ward@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of vertigo symptoms (time frame: During MRI up to 6 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 NCT06062368, which also lists 4 linked publications.
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 12 Nov 2025.