- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00593216
Diagnosis Of Vertigo With New Imaging
June 21, 2011 updated by: Boston University
New Diagnosis Of Vestibular Vertigo With Functional MRI
The purpose of this study is to determine the potential usefulness of new functional MRI in diagnostic assessment of patients presenting with vertigo.
Study Overview
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
Enrollment (Actual)
4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
primary care clinic
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Healthy
Healthy volunteers devoid of any ear problems
|
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 Names:
|
|
Vertigo
Patients with the symptoms of vertigo
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Activation of target sites on the functional MRI images during the vestibular response
Time Frame: Not specific
|
Not specific
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Differences in the fiber tracking of central nervous system specifically involved in the vestibular response
Time Frame: Not specific
|
Not specific
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kenneth Grundfast, M.D., Department of Otolaryngology- Head and Neck surgery of Boston University Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
January 2, 2008
First Submitted That Met QC Criteria
January 2, 2008
First Posted (Estimate)
January 14, 2008
Study Record Updates
Last Update Posted (Estimate)
June 23, 2011
Last Update Submitted That Met QC Criteria
June 21, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-25852
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.