VertigoNCT00593216
Diagnosis Of Vertigo With New Imaging
An observational study of Vertigo, run by Boston University.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vertigo
- What is being tested?
- Functional MRI imaging
- Type of treatment
- Medical device
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- Healthy volunteer or patient with symptom of vertigo
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Vertigo
- Being tested
- Functional MRI imaging
- Keywords
- functional magnetic Resonance Imaging, vertigo, vestibular
- Medical subject headings
- Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional MRI imagingDevice
Also called Magnetic Resonance 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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Healthy volunteers devoid of any ear problems Receives: Device: Functional MRI imaging | |
| Vertigo | Patients with the symptoms of vertigo Receives: Device: Functional MRI imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activation of target sites on the functional MRI images during the vestibular response
Measured: Not specific
Secondary outcomes (1)
Differences in the fiber tracking of central nervous system specifically involved in the vestibular response
Measured: Not specific
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2008 (estimated)
- Study startJul 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VertigoStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Investigators
- Kenneth Grundfast, M.D., Principal investigator, Department of Otolaryngology- Head and Neck surgery of Boston University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00593216
- Sponsor's protocol ID
- H-25852
- Status last verified
- Jun 2011
- First submitted
- 2 Jan 2008
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Diagnosis Of Vestibular Vertigo With Functional MRI
- ClinicalTrials.gov ID
- NCT00593216
- Acronym / sponsor ID
- H-25852
- Conditions
- Vertigo
- Keywords
- functional magnetic Resonance Imaging, vertigo, vestibular
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 14 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the potential usefulness of new functional MRI in diagnostic assessment of patients presenting with vertigo.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Device: Functional MRI imagingHealthy volunteers devoid of any ear problems |
| Vertigo | – | Device: Functional MRI imagingPatients with the symptoms of vertigo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (1 listed)
- Healthy volunteer or patient with symptom of vertigo
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional MRI imagingAlso: Magnetic Resonance ImagingThe 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. | Device | Healthy, Vertigo |
Primary outcome
Activation of target sites on the functional MRI images during the vestibular response
Time frame: Not specific
1 secondary outcome
Differences in the fiber tracking of central nervous system specifically involved in the vestibular response
Time frame: Not specific
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Grundfast, M.D. principal investigator
Department of Otolaryngology- Head and Neck surgery of Boston University Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Vertigo, run by Boston University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activation of target sites on the functional MRI images during the vestibular response (time frame: Not specific). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2011.