NCT06062368

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Jan 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress58%
Jan 2024Jan 2028

First Submitted

Initial submission to the registry

September 25, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 2, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

January 15, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

November 12, 2025

Status Verified

November 1, 2025

Enrollment Period

3 years

First QC Date

September 25, 2023

Last Update Submit

November 10, 2025

Conditions

Keywords

MRI7 TeslaMagnetic Vestibular Stimulation

Outcome Measures

Primary Outcomes (1)

  • 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.

    During MRI up to 6 minutes

Secondary Outcomes (2)

  • Intensity of Vertigo

    During MRI up to 6 minutes

  • Duration (seconds) of Vertigo

    During MRI up to 6 minutes

Study Arms (4)

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).

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).

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).

Behavioral: Rate of Entry

Interventions

Rate of EntryBEHAVIORAL

The participant will enter and exit the MRI scan at a slower rate than the manufacturer entry and exit.

1-minute entry2-minute entry3-minute entry

Eligibility Criteria

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

You may qualify if:

  • Participants who will be undergoing an MRI scan at a 7 Tesla MRI.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

RECRUITING

Related Publications (4)

  • 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.

    PMID: 26614577BACKGROUND
  • Mian 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.

    PMID: 24205304BACKGROUND
  • Roberts 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.

    PMID: 21945276BACKGROUND
  • Ward 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.

MeSH Terms

Conditions

VertigoDizziness

Condition Hierarchy (Ancestors)

Vestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSensation Disorders

Study Officials

  • Bryan Ward, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participant will be unaware of the group they are participating in.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2023

First Posted

October 2, 2023

Study Start

January 15, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

November 12, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Individual participant data will be used only by the investigators participating in this study at Johns Hopkins University School of Medicine.

Locations