NCT00593216

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2007

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 14, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

June 23, 2011

Status Verified

June 1, 2011

Enrollment Period

1.4 years

First QC Date

January 2, 2008

Last Update Submit

June 21, 2011

Conditions

Vertigo

Keywords

functional magnetic Resonance Imagingvertigovestibular

Outcome Measures

Primary Outcomes (1)

  • Activation of target sites on the functional MRI images during the vestibular response

    Not specific

Secondary Outcomes (1)

  • Differences in the fiber tracking of central nervous system specifically involved in the vestibular response

    Not specific

Study Arms (2)

Healthy

Healthy volunteers devoid of any ear problems

Device: Functional MRI imaging

Vertigo

Patients with the symptoms of vertigo

Device: Functional MRI imaging

Interventions

Functional MRI imagingDEVICE

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.

Also known as: Magnetic Resonance Imaging
HealthyVertigo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

primary care clinic

You may qualify if:

  • Healthy volunteer or patient with symptom of vertigo

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vertigo

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Vestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Kenneth Grundfast, M.D.

    Department of Otolaryngology- Head and Neck surgery of Boston University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 2, 2008

First Posted

January 14, 2008

Study Start

July 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

June 23, 2011

Record last verified: 2011-06