- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02615314
Clinical Aspects of Patients With Benign Paroxysmal Positional Vertigo (BPPV) and Migraine
November 25, 2015 updated by: Sertac Yetiser, Anadolu Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
232
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 84 years (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
BPPV patients only confirmed by VNG
Description
Inclusion Criteria:
- Patients who had history of head-induced positional and brief vertigo and who have been confirmed by VNG were included
Exclusion Criteria:
- Patients with balance problem other than BPPV,
- Patients receiving any medication prior to therapeutic maneuver were excluded
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Meltem Hale Gokmen, MD, Dept of Neurology, Anadolu Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Ishiyama A, Jacobson KM, Baloh RW. Migraine and benign positional vertigo. Ann Otol Rhinol Laryngol. 2000 Apr;109(4):377-80. doi: 10.1177/000348940010900407.
- Yetiser 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.
- von 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
November 14, 2015
First Submitted That Met QC Criteria
November 25, 2015
First Posted (Estimate)
November 26, 2015
Study Record Updates
Last Update Posted (Estimate)
November 26, 2015
Last Update Submitted That Met QC Criteria
November 25, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Otorhinolaryngologic Diseases
- Labyrinth Diseases
- Ear Diseases
- Vestibular Diseases
- Sensation Disorders
- Headache Disorders, Primary
- Headache Disorders
- Vertigo
- Benign Paroxysmal Positional Vertigo
- Dizziness
- Migraine Disorders
Other Study ID Numbers
- AnadoluMC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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