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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00593216
Other study ID # H-25852
Secondary ID
Status Completed
Phase N/A
First received January 2, 2008
Last updated June 21, 2011
Start date July 2007
Est. completion date December 2008

Study information

Verified date June 2011
Source Boston University
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 4
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Boston University

Outcome

Type Measure Description Time frame Safety issue
Primary Activation of target sites on the functional MRI images during the vestibular response Not specific No
Secondary Differences in the fiber tracking of central nervous system specifically involved in the vestibular response Not specific No
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