Ignite Creation Date:
2024-05-06 @ 7:36 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06062368
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2023-09-25
Brief Title:
Reducing Vertigo Associated With MRI Machines
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Reducing Vertigo Associated With MRI Machines
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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 23 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 utricles 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 enteringexiting at the usual 20 seconds 2 enteringexiting over 1 minute 3 enteringexiting over 2 minutes or 4 enteringexiting 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
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 enteringexiting at the usual 20 seconds 2 enteringexiting over 1 minute 3 enteringexiting over 2 minutes or 4 enteringexiting 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K23DC018302 | NIH | None | httpsreporternihgovquickSearchK23DC018302 |