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Diagnosis Of Vertigo With New Imaging

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ClinicalTrials.gov Identifier: NCT00593216
Recruitment Status : Completed
First Posted : January 14, 2008
Last Update Posted : June 23, 2011
Sponsor:
Information provided by:
Boston University

Brief Summary:
The purpose of this study is to determine the potential usefulness of new functional MRI in diagnostic assessment of patients presenting with vertigo.

Condition or disease Intervention/treatment
Vertigo Device: Functional MRI imaging

Detailed Description:
The incidence of vertigo has been reported to be as high as 1.5% in the general population and some reports suggest that more than 5% of adults experience some kind of vertigo each year. In 80% of affected individuals, this symptom resulted in a medical consultation, interruption of daily activities, or sick leave. Therefore, vertigo can have a significant impact on health and well being. Unfortunately, there is not yet any satisfactory objective method for diagnosis of vertigo. At present, the diagnosis usually depends on medical history, vestibular function tests, Dix-Hallpike positioning tests done in the office, and, to some extent imaging studies doen to look for such abnormalities such as acoustic tumor, brain tumor, and evidence of multiple sclerosis. A number of recent studies support the possibility of using functional MRI (fMRI), particularly a new diffusion tensor fiber tracking (DTT) technique, as a new tool for diagnosis of disorders that can cause vertigo. In this study, our hypothesis is that there is an alteration in the activity in neural pathways of patients with vertigo that can be detected by fMRI. To test this assumption, our objective in this study is to determine whether there is a difference between the fMRI images obtained in normal subjects versus those in patients with vertigo.

Study Type : Observational
Actual Enrollment : 4 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: New Diagnosis Of Vestibular Vertigo With Functional MRI
Study Start Date : July 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Healthy
Healthy volunteers devoid of any ear problems
Device: Functional MRI imaging
The functional MRI imaging of whole brain will be obtained before, during and after the vestibular response which is induced by the designated caloric stimulation. Post-imaging analysis will reveal which region or neural pathways in the central nervous system may attributed to the development of vertigo.
Other Name: Magnetic Resonance Imaging
Vertigo
Patients with the symptoms of vertigo
Device: Functional MRI imaging
The functional MRI imaging of whole brain will be obtained before, during and after the vestibular response which is induced by the designated caloric stimulation. Post-imaging analysis will reveal which region or neural pathways in the central nervous system may attributed to the development of vertigo.
Other Name: Magnetic Resonance Imaging



Primary Outcome Measures :
  1. Activation of target sites on the functional MRI images during the vestibular response [ Time Frame: Not specific ]

Secondary Outcome Measures :
  1. Differences in the fiber tracking of central nervous system specifically involved in the vestibular response [ Time Frame: Not specific ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic
Criteria

Inclusion Criteria:

  • Healthy volunteer or patient with symptom of vertigo

Exclusion Criteria:

  • Evidence of mental impairment
  • Any type of bioimplant or any type of ferromagnetic bioimplant
  • Pregnant females
  • Exhibit noticeable anxiety and/or claustrophobia
  • History of serious disease in central nervous and cerebrovascular systems.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00593216


Sponsors and Collaborators
Boston University
Investigators
Principal Investigator: Kenneth Grundfast, M.D. Department of Otolaryngology- Head and Neck surgery of Boston University Medical Center

Responsible Party: Kenneth Grundfast M.D., Department of Surgery-Otolaryngology of Boston University Medical Center
ClinicalTrials.gov Identifier: NCT00593216     History of Changes
Other Study ID Numbers: H-25852
First Posted: January 14, 2008    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: June 2011

Keywords provided by Boston University:
functional magnetic Resonance Imaging
vertigo
vestibular

Additional relevant MeSH terms:
Vertigo
Dizziness
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensation Disorders