- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06062368
Reducing Vertigo Associated With MRI Machines
Study Overview
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bryan K Ward, MD
- Phone Number: 443-997-6467
- Email: bryan.k.ward@gmail.com
Study Contact Backup
- Name: Adrian Paez, BA
- Phone Number: 443-923-9200
- Email: paez@kennedykrieger.org
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Recruiting
- Johns Hopkins University School of Medicine
-
Contact:
- Bryan K Ward, MD
- Phone Number: 443-997-6467
- Email: bryan.k.ward@gmail.com
-
Contact:
- Adrian Paez, BA
- Phone Number: 443-923-9200
- Email: paez@kennedykrieger.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants who will be undergoing an MRI scan at a 7 Tesla MRI.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Standard Duration
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.
|
|
|
Experimental: 1-minute entry
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).
|
The participant will enter and exit the MRI scan at a slower rate than the manufacturer entry and exit.
|
|
Experimental: 2-minute entry
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).
|
The participant will enter and exit the MRI scan at a slower rate than the manufacturer entry and exit.
|
|
Experimental: 3-minute entry
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).
|
The participant will enter and exit the MRI scan at a slower rate than the manufacturer entry and exit.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
During MRI up to 6 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intensity of Vertigo
Time Frame: During MRI up to 6 minutes
|
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
|
During MRI up to 6 minutes
|
|
Duration (seconds) of Vertigo
Time Frame: During MRI up to 6 minutes
|
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.
|
During MRI up to 6 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bryan Ward, MD, Johns Hopkins University
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00413291
- K23DC018302 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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