Vestibular System in Migrainous Vertigo Patients | NCT00901953

Studies
Vestibular System in Migrainous Vertigo Patients

NCT00901953

Sponsor

University of Bergen

Status

Unknown status

Last Update Posted

May 15, 2009Estimated

Enrollment

65Estimated

Phase

Not provided

Conditions

Migraine Disorders
Migraine Variant
Episodic Recurrent Vertigo

Interventions

Not provided

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

May 2009Actual

Completion Date

Sep 2009Estimated

First Submitted Date

May 12, 2009

First Submission Date that Met QC Criteria

May 12, 2009

First Posted Date

May 14, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 14, 2009

Last Update Posted Date

May 15, 2009Estimated

Name	Class
Sorlandet Hospital HF	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

65Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		migrainous vertigo
2		migraine without vertigo

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Differences in vestibular function		Symptomfree interval

Secondary Outcomes

Measure	Description	Time Frame
Differences in hypersensitivity		Symptomfree interval

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

61 Years

Standard Ages

ChildAdult

Study Population

Migraine patients: primary care clinic

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Åse Mygland, PhD	Institute of clinical medicine, university of Bergen, Norway	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of neurology, Sørlandet Hospital HF		Kristiansand	Kristiansand	4604	Norway

Condition Browse Module

MeSH Terms

ID	Term
D008881	Migraine Disorders
D020338	Vestibular Neuronitis

Ancestor Terms

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided