NCT02615314

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
232

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

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

January 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 26, 2015

Completed
Last Updated

November 26, 2015

Status Verified

November 1, 2015

Enrollment Period

5 months

First QC Date

November 14, 2015

Last Update Submit

November 25, 2015

Conditions

Keywords

migrainebenign paroxysmal positional vertigo

Outcome Measures

Primary Outcomes (1)

  • 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.

    7 days

Study Arms (2)

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.

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.

Procedure: Particle re-positioning maneuver

Interventions

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 migraineBPPV without migraine

Eligibility Criteria

Age10 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

BPPV patients only confirmed by VNG

You may qualify if:

  • Patients who had history of head-induced positional and brief vertigo and who have been confirmed by VNG were included

You may not qualify if:

  • Patients with balance problem other than BPPV,
  • Patients receiving any medication prior to therapeutic maneuver were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

MeSH Terms

Conditions

Migraine DisordersVertigoBenign Paroxysmal Positional Vertigo

Condition Hierarchy (Ancestors)

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

Study Officials

  • Meltem Hale Gokmen, MD

    Dept of Neurology, Anadolu Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor, Dept of ORL & HNS

Study Record Dates

First Submitted

November 14, 2015

First Posted

November 26, 2015

Study Start

January 1, 2015

Primary Completion

June 1, 2015

Study Completion

July 1, 2015

Last Updated

November 26, 2015

Record last verified: 2015-11