Migraine DisordersNCT07000929
Videonystagmography and Vestibular Migraine
An observational study of Migraine Disorders and Vertigo, run by Dr. med. Lukas Becker at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Migraine Disorders, Vertigo
- What is being tested?
- Videonystagmography
- How many people
- 175 participants
- Where
- 1 siteGermany
- Study dates
- 16 Oct 2023to 31 Dec 2025
- 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: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Westdeutsches Kopfschmerz und Schwindelzentrum der Klinik für Neurologie des Universitätklinikums Essen
Essen, North Rhine-Westphalia, 45147
About this study
Official title: The Use of Videonystagmography With Caloric Testing as an Instrumental Diagnostic Method for Vestibular Migraine
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.
Read the detailed description
Vestibular migraine is a young disorder that is caught between headache experts and vertigo experts. In 2012, the International Bárány Society for Neurootology and the International Headache Society were able to agree on a uniform definition and terminology for "vestibular migraine" in a jointly formulated consensus paper. A distinction is currently made between "definite" and "probable" vestibular migraine on the basis of the applicable diagnostic criteria. The diagnostic criteria are based on a study from 2001 with 75 patients and a follow-up period of 8 years, in which the diagnosis was confirmed in 84% of cases. At present the diagnostic criterion still requires the exclusion of another possible vestibular or ICHD diagnosis. Vestibular migraine is reported in the literature as the most common cause of spontaneous episodic vertigo attacks in adults and children. A manifestation is basically possible at any age. Despite the frequency of vestibular migraine and the sometimes pronounced level of suffering, the publication density is low and the diagnosis is mainly based on the patient medical history and clinical neurological examination. No specific instrumental diagnostic method or specific biomarkers that confirm or even prove the diagnosis are known. Larger studies with the intention of improving the diagnosis and thus achieving the expected reduction in the postulated high number of unreported cases have not yet been carried out. In the regular examination of patients with vertigo, videonystagmography with caloric testing is already an established and necessary examination procedure that is used to diagnose many different vertigo disorders. In the investigations, patients with confirmed vestibular migraine often show a vestibular hyperexcitability or increased caloric reaction not previously described in the literature. The investigators would like to verify this with this study. The investigators therefore developed the hypothesis of a possible correlation between a certain nystagmus frequency and/or certain speed of the slow phase of the nystagmus and the presence of a vestibular migraine. Comparisons with patients with headache migraine without accompanying vertigo symptoms and with a healthy control group should be carried out to test the hypothesis. First, all patients at the Dizziness Center at University Hospital Essen with diagnosed vestibular migraine without other conditions, except episodic or chronic migraine, were analyzed in the first quarter of 2023. This was followed by the inclusion of patients with episodic or chronic migraine and no vestibular migraine, standardized by age and gender, as well as the inclusion of a healthy control group without migraine headache and without vestibular migraine. Following that the collected data will be analyzed in particular the videonystagmography with caloric testing and the comparison of the groups.
- Conditions
- Migraine Disorders, Vertigo
- Being tested
- Videonystagmography
- Keywords
- Vestibular migraine, Vertigo, Migraine, Dizziness
- Medical subject headings
- Migraine Disorders, Vertigo, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Vestibular migraine confirmed | Patients who received a diagnosis of vestibular migraine. Patients were included in the study retrospectively. Receives: Diagnostic Test: Videonystagmography | |
| Episodic or chronic migraine, without vestibular migraine | Participants who received a diagnosis of episodic or chronic migraine without vestibular migraine. Participants were included in the study prospectively. Receives: Diagnostic Test: Videonystagmography | |
| Healthy participants | Participants who not received a diagnosis of episodic or chronic migraine nor vestibular migraine. Participants were included in the study prospectively. Receives: Diagnostic Test: Videonystagmography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: result of head impulse test at study enrollment, Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start16 Oct 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Other
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. med. Lukas Becker
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Essen
- Responsible party
- Sponsor-investigator, Dr. med. Lukas Becker, Universitätsklinikum Essen
- Investigators
- Dagny Holle-Lee, Prof. Dr. med., Study director, Klinik für Neurologie, Universitätsklinikum Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000929
- Sponsor's protocol ID
- VM_LB_DHL
- Status last verified
- Aug 2026
- First submitted
- 14 May 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 37597072Muelleman 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.
PubMed 28498271Lempert 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.
PubMed 23142830
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Videonystagmography With Caloric Testing as an Instrumental Diagnostic Method for Vestibular Migraine
- ClinicalTrials.gov ID
- NCT07000929
- Acronym / sponsor ID
- VM_LB_DHL
- Conditions
- Migraine Disorders, Vertigo
- Keywords
- Vestibular migraine, Vertigo, Migraine, Dizziness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Dr. med. Lukas BeckerUniversity, hospital or other
- Collaborators
- University Hospital, Essen
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 3 Jun 2025 (actual)
- 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.
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.
Detailed description
Vestibular migraine is a young disorder that is caught between headache experts and vertigo experts. In 2012, the International Bárány Society for Neurootology and the International Headache Society were able to agree on a uniform definition and terminology for "vestibular migraine" in a jointly formulated consensus paper. A distinction is currently made between "definite" and "probable" vestibular migraine on the basis of the applicable diagnostic criteria. The diagnostic criteria are based on a study from 2001 with 75 patients and a follow-up period of 8 years, in which the diagnosis was confirmed in 84% of cases. At present the diagnostic criterion still requires the exclusion of another possible vestibular or ICHD diagnosis. Vestibular migraine is reported in the literature as the most common cause of spontaneous episodic vertigo attacks in adults and children. A manifestation is basically possible at any age. Despite the frequency of vestibular migraine and the sometimes pronounced level of suffering, the publication density is low and the diagnosis is mainly based on the patient medical history and clinical neurological examination. No specific instrumental diagnostic method or specific biomarkers that confirm or even prove the diagnosis are known. Larger studies with the intention of improving the diagnosis and thus achieving the expected reduction in the postulated high number of unreported cases have not yet been carried out. In the regular examination of patients with vertigo, videonystagmography with caloric testing is already an established and necessary examination procedure that is used to diagnose many different vertigo disorders. In the investigations, patients with confirmed vestibular migraine often show a vestibular hyperexcitability or increased caloric reaction not previously described in the literature. The investigators would like to verify this with this study. The investigators therefore developed the hypothesis of a possible correlation between a certain nystagmus frequency and/or certain speed of the slow phase of the nystagmus and the presence of a vestibular migraine. Comparisons with patients with headache migraine without accompanying vertigo symptoms and with a healthy control group should be carried out to test the hypothesis. First, all patients at the Dizziness Center at University Hospital Essen with diagnosed vestibular migraine without other conditions, except episodic or chronic migraine, were analyzed in the first quarter of 2023. This was followed by the inclusion of patients with episodic or chronic migraine and no vestibular migraine, standardized by age and gender, as well as the inclusion of a healthy control group without migraine headache and without vestibular migraine. Following that the collected data will be analyzed in particular the videonystagmography with caloric testing and the comparison of the groups.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vestibular migraine confirmed | – | Diagnostic Test: VideonystagmographyPatients who received a diagnosis of vestibular migraine. Patients were included in the study retrospectively. |
| Episodic or chronic migraine, without vestibular migraine | – | Diagnostic Test: VideonystagmographyParticipants who received a diagnosis of episodic or chronic migraine without vestibular migraine. Participants were included in the study prospectively. |
| Healthy participants | – | Diagnostic Test: VideonystagmographyParticipants who not received a diagnosis of episodic or chronic migraine nor vestibular migraine. Participants were included in the study prospectively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| VideonystagmographyIn 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. | Diagnostic test | Episodic or chronic migraine, without vestibular migraine, Healthy participants, Vestibular migraine confirmed |
Primary outcome
mean comparison nystagmus frequency
Time frame: Mean of nystagmus frequency at study enrollment, Baseline
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 comparison GLP (speed of the slow phase) of nystagmus in °/s or sum of °/s
Time frame: Mean of nystagmus GLP at study enrollment, Baseline
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
Comparison head impulse test (vHIT)
Time frame: result of head impulse test at study enrollment, Baseline
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
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 2 Nov 2026.
- Background: PubMed 37597072Rocha 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.
- Background: PubMed 28498271Muelleman 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.
- Background: PubMed 23142830Lempert 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.
- Individual participant dataSharing planned: No. 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.
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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.
Dagny Holle-Lee, Prof. Dr. med. study director
Klinik für Neurologie, Universitätsklinikum Essen
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 Vertigo, run by Dr. med. Lukas Becker at 1 site in Germany.
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 3 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 2 Nov 2026. 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 Germany. 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?
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?
mean comparison nystagmus frequency (time frame: Mean of nystagmus frequency at study enrollment, Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07000929, which also lists 3 linked publications.
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 2 Nov 2026.