Diagnosis Of Vertigo With New Imaging

This study has been completed.
Sponsor:
Information provided by:
Boston University
ClinicalTrials.gov Identifier:
NCT00593216
First received: January 2, 2008
Last updated: June 21, 2011
Last verified: June 2011
  Purpose

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


Condition Intervention
Vertigo
Device: Functional MRI imaging

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: New Diagnosis Of Vestibular Vertigo With Functional MRI

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • Activation of target sites on the functional MRI images during the vestibular response [ Time Frame: Not specific ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Differences in the fiber tracking of central nervous system specifically involved in the vestibular response [ Time Frame: Not specific ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: July 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: January 2, 2008
Last Updated: June 21, 2011
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on August 28, 2014