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临床试验/NCT06062368
NCT06062368招募中不适用

Reducing Vertigo Associated With MRI Machines

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Prevalence of vertigo symptoms

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

The participant will be unaware of the group they are participating in.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Participants who will be undergoing an MRI scan at a 7 Tesla MRI.

排除标准

  • •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.

研究组 & 干预措施

Standard Duration

No 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.

1-minute entry

Experimental

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).

干预措施: Rate of Entry (Behavioral)

2-minute entry

Experimental

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).

干预措施: Rate of Entry (Behavioral)

3-minute entry

Experimental

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).

干预措施: Rate of Entry (Behavioral)

结局指标

主要结局

Prevalence of vertigo symptoms

时间窗: 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.

次要结局

  • Intensity of Vertigo(During MRI up to 6 minutes)
  • Duration (seconds) of Vertigo(During MRI up to 6 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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