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

Trial Summary

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 data supports the effectiveness of the treatment Slower MRI Machine Entry for Vertigo?

The research highlights the importance of MRI in diagnosing vertigo-related conditions, suggesting that a slower entry into the MRI machine might help reduce anxiety and discomfort, potentially improving the accuracy of the imaging results for patients with vertigo. ^{1 2 3 4 5}

How does the treatment 'Slower MRI Machine Entry for Vertigo' differ from other treatments for vertigo?

This treatment is unique because it focuses on the method of entering the MRI machine more slowly, which may help reduce vertigo symptoms during the scan. Unlike other treatments that might involve medication or physical therapy, this approach modifies the MRI procedure itself to potentially alleviate discomfort. ^{1 2 3 6 7}

What is the purpose of this trial?

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.

Research Team

Bryan Ward, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Vertigo-related cerebral blood flow changes on magnetic resonance imaging. [2014]

2. Italy pubmed.ncbi.nlm.nih.gov

Neuroradiological features of vertigo. [2016]

3. Norway 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. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

The costs and utility of imaging in evaluating dizzy patients in the emergency room. [2018]

5. Italy pubmed.ncbi.nlm.nih.gov

[Changes in the blood-labyrinth barrier. Assessments by magnetic resonance]. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

MRI Artifacts and Cochlear Implant Positioning at 3 T In Vivo. [2022]

7. Japan 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. [2004]