MigraineNCT02615314
Clinical Aspects of Patients With Benign Paroxysmal Positional Vertigo (BPPV) and Migraine
An observational study of Migraine and Positional Vertigo, run by Anadolu Medical Center.
Trial summary
The aim of this study is to analyze the clinical aspects of patients with BPPV associated with migraine. It is our purpose to clarify weather migraine is a risk factor for BPPV if the clinical aspect and the therapeutic outcome is different. Read more about this study
- Who is it for?
- Ages 10 to 84 years
- Conditions the study is for
- Migraine, Positional Vertigo
- What is being tested?
- Particle re-positioning maneuver
- Type of treatment
- Surgery or procedure
- How many people
- 232 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jul 2015
- 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 10 to 84 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: BPPV patients only confirmed by VNG
Who may be able to join
- Patients who had history of head-induced positional and brief vertigo and who have been confirmed by VNG were included
Who cannot join
- Patients with balance problem other than BPPV,
- Patients receiving any medication prior to therapeutic maneuver were excluded
About this study
The aim of this study is to analyze the clinical aspects of patients with BPPV associated with migraine. It is our purpose to clarify weather migraine is a risk factor for BPPV if the clinical aspect and the therapeutic outcome is different.
Read the detailed description
Two hundred and sixty-three patients with BPPV were enrolled in this retrospective study. All patients' charts were reviewed by independent observer. The type of BPPV and associated problems were noted. Patients with migraine were investigated in terms of age, gender, symptoms, affected side and the cure rate. Their data were compared with those having no migraine. Mean values and standard deviations (± SD) were calculated. One way ANOVA test was used for the analysis. Significance was set at p < 0.005.
- Conditions
- Migraine, Positional Vertigo
- Being tested
- Particle re-positioning maneuver
- Keywords
- migraine, benign paroxysmal positional vertigo
- Medical subject headings
- Migraine Disorders, Vertigo, Benign Paroxysmal Positional Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Particle re-positioning maneuverProcedure or surgery
Patients with posterior canal BPPV (PC-BPPV) were treated with Epley maneuver. Patients with superior canal (SC-BPPV) were treated with Li or reverse Epley maneuver. Patients with lateral canal (LC) apogeotropic or geotropic nystagmus were treated with Barbeque, Semont's or Gufoni maneuvers. If geotropic or ageotropic type nystagmus is equal intensity on both sides. The involved side was determined according to the patient sense of disturbance or lying down positioning test. If the patient has involvement of both sides according to Dix-Hallpike maneuver. Therapeutic maneuver was applied to the more severe side. All patients were re-evaluated at maximum 7 days.
| Study group | Role | What they receive |
|---|---|---|
| BPPV without migraine | Two hundred and sixty-three patients with BPPV (2009-2014), confirmed by videonystagmography (VNG), were enrolled in the study. Patients' charts were reviewed. They were grouped as those with or without migraine. Distribution of gender, age, duration of symptoms and affected side were reviewed. Two hundred and thirty-one patients with no migraine were identified. Receives: Procedure: Particle re-positioning maneuver | |
| BPPV with migraine | Thirty-two patients (11.4%) with migraine were identified. Diagnosis and classification of migraine and its differentiation from other type of headaches was based on third edition of International classification of headache disorders (ICHD-III beta) by international headache society (IHS). All patients with migraine had migrainous headache with or without aura and they all were diagnosed in our institution and followed by our neurology staff. Receives: Procedure: Particle re-positioning maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who had normal vestibular response to provocative tests 7 days after re-positioning maneuver
Every patient with BPPV who had positional nystagmus during Dix-Hallpike and head-roll provocative maneuvers will be treated with Epley or barbeque particle re-positioning maneuvers. Balance (positional nystagmus) of patients 7 days after re-positioning maneuvers will be assessed.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies 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
- Cross-sectional
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anadolu Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sertac Yetiser, Anadolu Medical Center
- Investigators
- Meltem Hale Gokmen, MD, Principal investigator, Dept of Neurology, Anadolu Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02615314
- Sponsor's protocol ID
- AnadoluMC
- Status last verified
- Nov 2015
- First submitted
- 14 Nov 2015
- Last updated
- 26 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Uneri A. Migraine and benign paroxysmal positional vertigo: an outcome study of 476 patients. Ear Nose Throat J. 2004 Dec;83(12):814-5.
PubMed 15724736Ishiyama A, Jacobson KM, Baloh RW. Migraine and benign positional vertigo. Ann Otol Rhinol Laryngol. 2000 Apr;109(4):377-80. doi: 10.1177/000348940010900407.
PubMed 10778892Yetiser S, Ince D. Demographic analysis of benign paroxysmal positional vertigo as a common public health problem. Ann Med Health Sci Res. 2015 Jan-Feb;5(1):50-3. doi: 10.4103/2141-9248.149788.
PubMed 25745577von Brevern M, Radtke A, Lezius F, Feldmann M, Ziese T, Lempert T, Neuhauser H. Epidemiology of benign paroxysmal positional vertigo: a population based study. J Neurol Neurosurg Psychiatry. 2007 Jul;78(7):710-5. doi: 10.1136/jnnp.2006.100420. Epub 2006 Nov 29.
PubMed 17135456
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Aspects of Patients With Benign Paroxysmal Positional Vertigo (BPPV) and Migraine
- ClinicalTrials.gov ID
- NCT02615314
- Acronym / sponsor ID
- AnadoluMC
- Conditions
- Migraine, Positional Vertigo
- Keywords
- migraine, benign paroxysmal positional vertigo
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Anadolu Medical CenterUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 26 Nov 2015 (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.
The aim of this study is to analyze the clinical aspects of patients with BPPV associated with migraine. It is our purpose to clarify weather migraine is a risk factor for BPPV if the clinical aspect and the therapeutic outcome is different.
Detailed description
Two hundred and sixty-three patients with BPPV were enrolled in this retrospective study. All patients' charts were reviewed by independent observer. The type of BPPV and associated problems were noted. Patients with migraine were investigated in terms of age, gender, symptoms, affected side and the cure rate. Their data were compared with those having no migraine. Mean values and standard deviations (± SD) were calculated. One way ANOVA test was used for the analysis. Significance was set at p < 0.005.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BPPV without migraine | – | Procedure: Particle re-positioning maneuverTwo hundred and sixty-three patients with BPPV (2009-2014), confirmed by videonystagmography (VNG), were enrolled in the study. Patients' charts were reviewed. They were grouped as those with or without migraine. Distribution of gender, age, duration of symptoms and affected side were reviewed. Two hundred and thirty-one patients with no migraine were identified. |
| BPPV with migraine | – | Procedure: Particle re-positioning maneuverThirty-two patients (11.4%) with migraine were identified. Diagnosis and classification of migraine and its differentiation from other type of headaches was based on third edition of International classification of headache disorders (ICHD-III beta) by international headache society (IHS). All patients with migraine had migrainous headache with or without aura and they all were diagnosed in our institution and followed by our neurology staff. |
Who may qualify
- Ages
- 10 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- BPPV patients only confirmed by VNG
Key inclusion criteria (1 listed)
- Patients who had history of head-induced positional and brief vertigo and who have been confirmed by VNG were included
Key exclusion criteria (2 listed)
- Patients with balance problem other than BPPV,
- Patients receiving any medication prior to therapeutic maneuver were excluded
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 |
|---|---|---|
| Particle re-positioning maneuverPatients with posterior canal BPPV (PC-BPPV) were treated with Epley maneuver. Patients with superior canal (SC-BPPV) were treated with Li or reverse Epley maneuver. Patients with lateral canal (LC) apogeotropic or geotropic nystagmus were treated with Barbeque, Semont's or Gufoni maneuvers. If geotropic or ageotropic type nystagmus is equal intensity on both sides. The involved side was determined according to the patient sense of disturbance or lying down positioning test. If the patient has involvement of both sides according to Dix-Hallpike maneuver. Therapeutic maneuver was applied to the more severe side. All patients were re-evaluated at maximum 7 days. | Procedure or surgery | BPPV with migraine, BPPV without migraine |
Primary outcome
Number of patients who had normal vestibular response to provocative tests 7 days after re-positioning maneuver
Time frame: 7 days
Every patient with BPPV who had positional nystagmus during Dix-Hallpike and head-roll provocative maneuvers will be treated with Epley or barbeque particle re-positioning maneuvers. Balance (positional nystagmus) of patients 7 days after re-positioning maneuvers will be assessed.
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 26 Nov 2015.
- Results publication: PubMed 15724736Uneri A. Migraine and benign paroxysmal positional vertigo: an outcome study of 476 patients. Ear Nose Throat J. 2004 Dec;83(12):814-5.
- Results publication: PubMed 10778892Ishiyama A, Jacobson KM, Baloh RW. Migraine and benign positional vertigo. Ann Otol Rhinol Laryngol. 2000 Apr;109(4):377-80. doi: 10.1177/000348940010900407.
- Results publication: PubMed 25745577Yetiser S, Ince D. Demographic analysis of benign paroxysmal positional vertigo as a common public health problem. Ann Med Health Sci Res. 2015 Jan-Feb;5(1):50-3. doi: 10.4103/2141-9248.149788.
- Results publication: PubMed 17135456von Brevern M, Radtke A, Lezius F, Feldmann M, Ziese T, Lempert T, Neuhauser H. Epidemiology of benign paroxysmal positional vertigo: a population based study. J Neurol Neurosurg Psychiatry. 2007 Jul;78(7):710-5. doi: 10.1136/jnnp.2006.100420. Epub 2006 Nov 29.
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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.
Meltem Hale Gokmen, MD principal investigator
Dept of Neurology, Anadolu Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine and Positional Vertigo, run by Anadolu Medical Center.
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 1 inclusion and 2 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 26 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of patients who had normal vestibular response to provocative tests 7 days after re-positioning maneuver (time frame: 7 days). 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 NCT02615314, which also lists 4 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 26 Nov 2015.