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Reducing Vertigo Associated With MRI Machines

Primary Purpose

Vertigo, Dizziness

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rate of Entry
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vertigo focused on measuring MRI, 7 Tesla, Magnetic Vestibular Stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Johns Hopkins University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Standard Duration

1-minute entry

2-minute entry

3-minute entry

Arm Description

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.

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 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 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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.

Full Information

First Posted
September 25, 2023
Last Updated
September 25, 2023
Sponsor
Johns Hopkins University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT06062368
Brief Title
Reducing Vertigo Associated With MRI Machines
Official Title
Reducing Vertigo Associated With MRI Machines
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertigo, Dizziness
Keywords
MRI, 7 Tesla, Magnetic Vestibular Stimulation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
The participant will be unaware of the group they are participating in.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Duration
Arm Type
No Intervention
Arm Description
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.
Arm Title
1-minute entry
Arm Type
Experimental
Arm Description
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).
Arm Title
2-minute entry
Arm Type
Experimental
Arm Description
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).
Arm Title
3-minute entry
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Rate of Entry
Intervention Description
The participant will enter and exit the MRI scan at a slower rate than the manufacturer entry and exit.
Primary Outcome Measure Information:
Title
Prevalence of vertigo symptoms
Description
Participants will report the presence and intensity of their vertigo. The presence or absence of vertigo for each group will be the primary outcome.
Time Frame
During MRI up to 6 minutes
Secondary Outcome Measure Information:
Title
Intensity of Vertigo
Description
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
Time Frame
During MRI up to 6 minutes
Title
Duration (seconds) of Vertigo
Description
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.
Time Frame
During MRI up to 6 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bryan K Ward, MD
Phone
443-997-6467
Email
bryan.k.ward@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Adrian Paez, BA
Phone
443-923-9200
Email
paez@kennedykrieger.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan Ward, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bryan K Ward, MD
Phone
443-997-6467
Email
bryan.k.ward@gmail.com
First Name & Middle Initial & Last Name & Degree
Adrian Paez, BA
Phone
443-923-9200
Email
paez@kennedykrieger.org

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will be used only by the investigators participating in this study at Johns Hopkins University School of Medicine.
Citations:
PubMed Identifier
26614577
Citation
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.
Results Reference
background
PubMed Identifier
24205304
Citation
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.
Results Reference
background
PubMed Identifier
21945276
Citation
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.
Results Reference
background
PubMed Identifier
30969883
Citation
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.
Results Reference
result

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Reducing Vertigo Associated With MRI Machines

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