Migraine DisordersNCT00901953
Vestibular System in Migrainous Vertigo Patients
An observational study of Migraine Disorders and Migraine Variant, run by University of Bergen at 1 site in Norway.
Trial summary
Do migrainous vertigo patients have more pathology in their vestibular system than migraine patients without vertigo? The aim of this study is to compare the vestibular system of migraine patients with and without vertigo in the symptom-free period by vestibular function tests, videonystagmography, vestibular evoked… Read more about this study
- Who is it for?
- Ages 16 to 61 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine Disorders, Migraine Variant, Episodic Recurrent Vertigo
- How many people
- 65 participants
- Where
- 1 siteNorway
- Study dates
- May 2007to Sep 2009
- 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 16 to 61 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Migraine patients: primary care clinic Migrainous vertigo patients: Neurological outpatients clinic, Sorlandet Hospital HF, Kristiansand and Spesialistsenteret, Tollbodgata 4, Kristiansand.
Who may be able to join
- migraine according to IHS criteria
- migrainous vertigo according to the Neuhauser-criteria
Who cannot join
- no history of other neurological, vestibular, opthalmologic and ENT disorders
- no medications that could possibly influence test results
- intact hearing measured by audiometry
- pregnancy
Trial locations and contacts
1 site in 1 country.
Norway1 site
Dept. of neurology, Sørlandet Hospital HF
Kristiansand, Kristiansand, 4604
About this study
Official title: Do Migrainous Vertigo Patients Have More Hypersensitivity in Their Vestibular System Than Migraine Patients Without Vertigo?
Do migrainous vertigo patients have more pathology in their vestibular system than migraine patients without vertigo?
The aim of this study is to compare the vestibular system of migraine patients with and without vertigo in the symptom-free period by vestibular function tests, videonystagmography, vestibular evoked myogenic potentials, and subjective visual vertical.
- Keywords
- migraine, migrainous vertigo, vestibular evoked myogenic potentials, vestibular function test, vestibular disorders
- Medical subject headings
- Migraine Disorders, Vestibular Neuronitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | migrainous vertigo | |
| 2 | migraine without vertigo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in vestibular function
Measured: Symptomfree interval
Secondary outcomes (1)
Differences in hypersensitivity
Measured: Symptomfree interval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2009 (estimated)
- Study startMay 2007
- Primary completionMay 2009
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- Sorlandet Hospital HF
- Investigators
- Åse Mygland, PhD, Principal investigator, Institute of clinical medicine, university of Bergen, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901953
- Sponsor's protocol ID
- 2.2006.3376
- Status last verified
- May 2009
- First submitted
- 12 May 2009
- Last updated
- 15 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Migrainous Vertigo Patients Have More Hypersensitivity in Their Vestibular System Than Migraine Patients Without Vertigo?
- ClinicalTrials.gov ID
- NCT00901953
- Acronym / sponsor ID
- 2.2006.3376
- Keywords
- migraine, migrainous vertigo, vestibular evoked myogenic potentials, vestibular function test, vestibular disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- Sorlandet Hospital HF
- Study start
- May 2007
- Primary completion
- May 2009 (actual)
- Study completion
- Sep 2009 (estimated)
- First posted
- 14 May 2009 (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.
Do migrainous vertigo patients have more pathology in their vestibular system than migraine patients without vertigo?
The aim of this study is to compare the vestibular system of migraine patients with and without vertigo in the symptom-free period by vestibular function tests, videonystagmography, vestibular evoked myogenic potentials, and subjective visual vertical.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –migrainous vertigo |
| 2 | – | –migraine without vertigo |
Who may qualify
- Ages
- 16 to 61 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Migraine patients: primary care clinic Migrainous vertigo patients: Neurological outpatients clinic, Sorlandet Hospital HF, Kristiansand and Spesialistsenteret, Tollbodgata 4, Kristiansand.
Key inclusion criteria (2 listed)
- migraine according to IHS criteria
- migrainous vertigo according to the Neuhauser-criteria
Key exclusion criteria (4 listed)
- no history of other neurological, vestibular, opthalmologic and ENT disorders
- no medications that could possibly influence test results
- intact hearing measured by audiometry
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Differences in vestibular function
Time frame: Symptomfree interval
1 secondary outcome
Differences in hypersensitivity
Time frame: Symptomfree interval
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2009.
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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.
Åse Mygland, PhD principal investigator
Institute of clinical medicine, university of Bergen, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine Disorders and Migraine Variant, run by University of Bergen at 1 site in Norway.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 15 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Differences in vestibular function (time frame: Symptomfree interval). 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 15 May 2009.