NCT00901953

Brief 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 myogenic potentials, and subjective visual vertical.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 14, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

May 15, 2009

Status Verified

May 1, 2009

Enrollment Period

2 years

First QC Date

May 12, 2009

Last Update Submit

May 14, 2009

Conditions

Migraine DisordersMigraine VariantEpisodic Recurrent Vertigo

Keywords

migrainemigrainous vertigovestibular evoked myogenic potentialsvestibular function testvestibular disorders

Outcome Measures

Primary Outcomes (1)

  • Differences in vestibular function

    Symptomfree interval

Secondary Outcomes (1)

  • Differences in hypersensitivity

    Symptomfree interval

Study Arms (2)

1

migrainous vertigo

2

migraine without vertigo

Eligibility Criteria

Age16 Years - 61 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Migraine patients: primary care clinic Migrainous vertigo patients: Neurological outpatients clinic, Sorlandet Hospital HF, Kristiansand and Spesialistsenteret, Tollbodgata 4, Kristiansand.

You may qualify if:

  • migraine according to IHS criteria
  • migrainous vertigo according to the Neuhauser-criteria

You may not qualify if:

  • no history of other neurological, vestibular, opthalmologic and ENT disorders
  • no medications that could possibly influence test results
  • intact hearing measured by audiometry
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of neurology, Sørlandet Hospital HF

Kristiansand, Kristiansand, 4604, Norway

Location

MeSH Terms

Conditions

Migraine DisordersVestibular Neuronitis

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVestibulocochlear Nerve DiseasesRetrocochlear DiseasesEar DiseasesOtorhinolaryngologic DiseasesCranial Nerve Diseases

Study Officials

  • Åse Mygland, PhD

    Institute of clinical medicine, university of Bergen, Norway

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 12, 2009

First Posted

May 14, 2009

Study Start

May 1, 2007

Primary Completion

May 1, 2009

Study Completion

September 1, 2009

Last Updated

May 15, 2009

Record last verified: 2009-05

Locations

NO(1)