NCT07000929

Brief Summary

In the study, the investigators would like to examine whether there is a difference between patients with vestibular migraine, patients with episodic or chronic migraine and healthy subjects in the examination of videonystagmography, which has been used for many years to differentiate and diagnose vertigo disorders. Accordingly, videonystagmography could also be discussed as an important diagnostic instrument for the diagnosis of the still young disease vestibular migraine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
173

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

October 16, 2023

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 3, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 27, 2026

Status Verified

May 1, 2025

Enrollment Period

2.2 years

First QC Date

May 14, 2025

Last Update Submit

February 23, 2026

Conditions

Keywords

Vestibular migraineVertigoMigraineDizziness

Outcome Measures

Primary Outcomes (3)

  • mean comparison nystagmus frequency

    Comparison of the mean between the group of patients with vestibular migraine and the patients and healthy participants in the mean nystagmus frequency within 30 seconds

    Mean of nystagmus frequency at study enrollment, Baseline

  • mean comparison GLP (speed of the slow phase) of nystagmus in °/s or sum of °/s

    Comparison of the mean between the group of patients with vestibular migraine and the patients and healthy participants in the mean GLP of nystagmus in °/s or sum of °/s

    Mean of nystagmus GLP at study enrollment, Baseline

  • Comparison head impulse test (vHIT)

    Comparison of the mean between the group of patients with vestibular migraine and the patients and healthy participants in the qualitativ analysis of the head impulse test

    result of head impulse test at study enrollment, Baseline

Study Arms (3)

Vestibular migraine confirmed

Patients who received a diagnosis of vestibular migraine.

Diagnostic Test: Videonystagmography

Episodic or chronic migraine, without vestibular migraine

Patients who received a diagnosis of episodic or chronic migraine without vestibular migraine.

Diagnostic Test: Videonystagmography

Healthy participants

Patients who not received a diagnosis of episodic or chronic migraine nor vestibular migraine.

Diagnostic Test: Videonystagmography

Interventions

VideonystagmographyDIAGNOSTIC_TEST

In the regular examination of patients with vertigo, videonystagmography with thermal testing (caloric) is already an established and necessary examination procedure that is used to diagnose many different vertigo disorders.

Episodic or chronic migraine, without vestibular migraineHealthy participantsVestibular migraine confirmed

Eligibility Criteria

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

The sample of patients was recruited from the dizziness center of the University Hospital Essen. The patients with migraine were recruited partly from the headache center and partly via advertising. The healthy subjects were recruited through advertising.

You may qualify if:

  • Group 1: The diagnosis of vestibular migraine is confirmed.
  • Group 2: The diagnosis of episodic or chronic migraine is confirmed. There is no coexisting vestibular migraine.
  • Group 3: healthy subjects without vestibular migraine and episodic or chronic migraine

You may not qualify if:

  • Simultaneous presence of another confirmed vertigo disorder
  • A previous hearing loss
  • Simultaneous presence of a chronic disease that affects the sense of balance
  • Taking medication with a central effect that affects the sense of balance
  • An existing eardrum defect or a blocked ear canal due to earwax

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Westdeutsches Kopfschmerz und Schwindelzentrum der Klinik für Neurologie des Universitätklinikums Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

Related Publications (3)

  • Rocha MF, Sacks B, Al-Lamki A, Koohi N, Kaski D. Acute vestibular migraine: a ghost diagnosis in patients with acute vertigo. J Neurol. 2023 Dec;270(12):6155-6158. doi: 10.1007/s00415-023-11930-9. Epub 2023 Aug 19. No abstract available.

    PMID: 37597072BACKGROUND
  • Muelleman T, Shew M, Subbarayan R, Shum A, Sykes K, Staecker H, Lin J. Epidemiology of Dizzy Patient Population in a Neurotology Clinic and Predictors of Peripheral Etiology. Otol Neurotol. 2017 Jul;38(6):870-875. doi: 10.1097/MAO.0000000000001429.

    PMID: 28498271BACKGROUND
  • Lempert T, Olesen J, Furman J, Waterston J, Seemungal B, Carey J, Bisdorff A, Versino M, Evers S, Newman-Toker D. Vestibular migraine: diagnostic criteria. J Vestib Res. 2012;22(4):167-72. doi: 10.3233/VES-2012-0453.

    PMID: 23142830BACKGROUND

MeSH Terms

Conditions

Migraine DisordersVertigoDizziness

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSensation Disorders

Study Officials

  • Dagny Holle-Lee, Prof. Dr. med.

    Klinik für Neurologie, Universitätsklinikum Essen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 14, 2025

First Posted

June 3, 2025

Study Start

October 16, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

February 27, 2026

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Disclosure of personal hospital data was not agreed in the ethics vote. The patient was informed with the indication that the data would not be passed on.

Locations