Slower MRI Machine Entry for Vertigo

Overseen By Adrian Paez, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Pacemaker, Metal implants, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Up to 6 minutes per session

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether slowing the entry speed into MRI machines can reduce dizziness and vertigo (a spinning sensation). Researchers believe that taking more time to enter the MRI's magnetic field might lessen these uncomfortable feelings. Participants will be tested with entry speeds ranging from 20 seconds to 3 minutes. Individuals already scheduled for an MRI scan at a 7 Tesla MRI, without certain metal implants or severe claustrophobia, might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to understanding how to improve MRI procedures for patient comfort.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications, so it's unclear. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this slower MRI machine entry is safe for patients?

Studies have shown that entering an MRI machine more slowly can reduce or even stop dizziness and symptoms like involuntary eye movement. Research indicates that when people took longer to enter and exit a 7 Tesla MRI scanner, their dizziness was less severe or completely gone.

Available data does not report any harmful effects from entering the machine more slowly. Taking time to get into the MRI machine helps without causing additional problems. Based on current research, adjusting the speed of entry appears safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how varying the speed of entry into an MRI machine might affect people with vertigo. Traditional MRI protocols don't typically consider the entry speed, which is usually around 20 seconds. This trial tests slower entry speeds of 1, 2, and 3 minutes to see if they reduce vertigo symptoms. By slowing down the entry, researchers hope to make MRIs more comfortable and accessible for people who experience vertigo, potentially expanding the use of MRIs for diagnosis and monitoring in this population.

What evidence suggests that this protocol is effective for reducing vertigo during MRI?

Previous studies have shown that taking more time to enter and exit a high-field MRI machine can reduce or even eliminate feelings of vertigo and dizziness. Moving slowly allows the inner ear to better adjust to changes caused by the strong magnetic field. Specifically, research found that longer entry times decreased vertigo symptoms and reduced involuntary eye movement (nystagmus). In this trial, participants will be assigned to different arms with varying entry times—one, two, or three minutes—to evaluate the effectiveness of these slower entry rates in reducing uncomfortable sensations. This approach suggests that slowing down the entry process can effectively manage vertigo during MRI scans. ^{1 2 3 4 6}

Who Is on the Research Team?

Bryan Ward, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for people who are scheduled to have an MRI scan at a high-strength magnet (7 Tesla). They must not have pacemakers, defibrillators, metal implants, cochlear implants, or ferromagnetic clips in the brain. Pregnant individuals and those with severe claustrophobia or any contraindications from the standard MRI questionnaire cannot participate.

Inclusion Criteria

You are not scheduled to have an MRI scan using a 7 Tesla MRI machine.

Exclusion Criteria

You have a pacemaker, defibrillator wires, metal implants, cochlear implants, or certain metal clips in your brain.

Pregnancy

If you are afraid of small or enclosed spaces, you may not be able to complete the test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo MRI scans with varying rates of entry and exit into the magnetic field to assess vertigo symptoms

Up to 6 minutes per session

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Rate of Entry

Trial Overview

The study tests if entering the strong magnetic field of an MRI machine more slowly can reduce vertigo and dizziness. Normally patients enter in 20 seconds; this will be extended to one, two, or three minutes. Participants' feelings of dizziness will be recorded as they go into and come out of the MRI.

How Is the Trial Designed?

Group I: 3-minute entry Experimental Treatment 1 Intervention

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).

Group II: 2-minute entry Experimental Treatment 1 Intervention

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).

Group III: 1-minute entry Experimental Treatment 1 Intervention

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).

Group IV: Standard Duration Active Control 1 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.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Published Research Related to This Trial

In a study of 23 patients with vertigo and 24 normal controls, the majority of patients showed normal cerebral blood flow (CBF), indicating that decreased vertebral flow may not be a common issue in these patients.

The study utilized a reliable MR imaging technique to measure CBF, demonstrating that while some patients had lower vertebral flow, the overall mean flow in patients did not significantly differ from that of healthy controls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measurement of cerebral blood flow with two-dimensional cine phase-contrast mR imaging: evaluation of normal subjects and patients with vertigo. Kashimada, A., Machida, K., Honda, N., et al.[2004]

In a study of 488 patients with sensorineural hearing loss and normal CT results, MRI revealed labyrinth abnormalities in 27% of those examined, highlighting its effectiveness in detecting conditions like tumors, infections, and hemorrhages that CT might miss.

MRI with contrast enhancement can differentiate between various labyrinth conditions, showing that while the labyrinth typically does not enhance with contrast, focal enhancements can indicate inflammation or previous surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Changes in the blood-labyrinth barrier. Assessments by magnetic resonance]. Manfrè, L., Bencivinni, F., Caronia, A., et al.[2015]

In a study of 1681 patients with dizziness in the emergency department, only 0.74% of CT scans revealed significant pathology, indicating that CT imaging may not be a cost-effective or useful diagnostic tool for this condition.

MRI showed a higher yield of significant abnormalities at 12.2%, but its use should be reserved for patients with additional neurological symptoms, as routine MRI for all dizziness cases is impractical.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The costs and utility of imaging in evaluating dizzy patients in the emergency room. Ahsan, SF., Syamal, MN., Yaremchuk, K., et al.[2018]

In a study of 33 patients with cervical vertigo and 14 healthy volunteers, significant changes in cerebral blood flow (CBF) were observed in specific brain regions, particularly the dorsal pons, during cervical vertigo episodes.

The findings suggest that cervical vertigo may be linked to reduced CBF in the dorsal pons, which could trigger the vestibular nuclei and contribute to the symptoms experienced by patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vertigo-related cerebral blood flow changes on magnetic resonance imaging. Chang, F., Li, Z., Xie, S., et al.[2014]

The study evaluated the impact of different positions of cochlear implant magnets on the visibility of the internal auditory canal (IAC) and labyrinth during 3T MRI, finding that specific angles and distances improved imaging quality.

Optimal magnet positions for better visualization were identified as 90 degrees and 9 cm, and 160 degrees and 9 cm, suggesting that adjusting the magnet's orientation can enhance assessment post-cochlear implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI Artifacts and Cochlear Implant Positioning at 3 T In Vivo. Todt, I., Rademacher, G., Mittmann, P., et al.[2022]

Accurate evaluation of medical history and physical examination is crucial in diagnosing vertigo, helping to differentiate between peripheral and central causes, while imaging techniques like CT and MR are used primarily to rule out other conditions.

For central vertigo, imaging studies are essential, with enhanced MR being the most sensitive method for detecting lesions, particularly in the posterior fossa, while diffusion-weighted MR can identify acute ischemic changes earlier than standard MR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroradiological features of vertigo. Bruzzone, MG., Grisoli, M., De Simone, T., et al.[2016]

In a study of 167 patients with vertigo, magnetic resonance imaging (MRI) identified potential causes of vertigo in 54 patients, with a significant number of pathologies found in the membranous labyrinth (44%) and other areas.

High-resolution MRI techniques, particularly the 3DFT-CISS sequence, are essential for detecting intralabyrinthine pathologies and vascular issues, making MRI the preferred method for diagnosing vertigo-related conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance examination of the inner ear and cerebellopontine angle in patients with vertigo and/or abnormal findings at vestibular testing. Casselman, JW., Kuhweide, R., Dehaene, I., et al.[2019]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10690370/

Longer duration entry mitigates nystagmus and vertigo in 7 ...

Increasing the duration of entry into and exit out of a 7T MRI scanner reduced or eliminated vertigo symptoms and reduced nystagmus peak SPV.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06062368

Reducing Vertigo Associated With MRI Machines

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).

3.

withpower.com

withpower.com/trial/phase-vertigo-11-2023-4fa99

Slower MRI Machine Entry for Vertigo

MRI showed a higher yield of significant abnormalities at 12.2%, but its use should be reserved for patients with additional neurological symptoms, as routine ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38046576/

Longer duration entry mitigates nystagmus and vertigo in 7 ...

Conclusion: Increasing the duration of entry into and exit out of a 7T MRI scanner reduced or eliminated vertigo symptoms and reduced nystagmus ...

5.

researchgate.net

researchgate.net/publication/375707295_Longer_duration_entry_mitigates_nystagmus_and_vertigo_in_7-Tesla_MRI

Longer duration entry mitigates nystagmus and vertigo in 7 ...

Conclusion Increasing the duration of entry into and exit out of a 7T MRI scanner reduced or eliminated vertigo symptoms and reduced nystagmus ...

6.

nature.com

nature.com/articles/s43856-024-00667-9

Modeling of magnetic vestibular stimulation experienced ...

The data showed a reversal of the nystagmus upon exiting the magnetic field28, and the peak response was delayed due to the time taken for ...