Vestibular Evoked Myogenic Potentials in Benign Paroxysmal Positional Vertigo (VEMP in BPPV)

Sponsor
Meir Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01004913
Collaborator
Clalit Health Services, Haifa and West Galilee (Other)
30
1
25
1.2

Study Details

Study Description

Brief Summary

Benign Paroxysmal Positional Vertigo (BPPV) is the most frequent cause of vertigo of peripheral vestibular origin with life time incidence of 2.4%. BPPV is characterized by bouts of acute whirling vertigo lasting less than one minute provoked by changes in head position in relation to the gravitational vector. The vertigo is accompanied by typical rotational or horizontal nystagmus that is often demonstrated by the Dix-Hallpike maneuver and less frequently by testing for positional nystagmus. BPPV pathogenesis is currently explained by the fall of otoconia (calcium-carbonate crystals) or otoconial debris from the tectorial membrane of the otolithic organs into the dependant semicircular canals (canalithiasis) or adherence of such particles to the semicircular canal's cupula (cupulithiasis). Under these circumstances, the semicircular canal which normally responds only to angular velocity and acceleration is stimulated by gravity. Otoconial remnants as free floating particles inside the semicircular canal arms or attached to the cupula have been observed by few investigators. Although the presence of such particles explains most characteristics of the positioning nystagmus described in BPPV, it does not account for the dizziness and disequilibrium which are described by many patients even without changes in head position and the continuation of such symptoms after successful treatment of BPPV as evidenced by the resolution of positional vertigo and nystagmus.

The study hypothesis is that otolithic pathology is an important component in the pathogenesis of BPPV explaining these symptoms, BPPV recurrence, and the refractoriness of some BPPV cases to the vastly employed particles repositioning treatments. In the present study the Vestibular Evoked Myogenic Potentials (VEMP) testing would be employed to measure the function of one of the otolithic organs - the saccule. The study objectives are: 1. To investigate possible malfunction of the saccule in patients suffering from BPPV. 2. To look for association between saccular pathology and BPPV recurrence and between such pathology and BPPV treatment failure. 3. To study possible relation between saccular pathology and continuation of dizziness and disequilibrium despite the resolution of positional vertigo.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of the Otolithic Organs Function in Patients Suffering From Benign Paroxysmal Positional Vertigo (BPPV) by Vestibular Evoked Myogenic Potentials (VEMP).
    Study Start Date :
    Nov 1, 2009
    Actual Primary Completion Date :
    Nov 1, 2011
    Actual Study Completion Date :
    Dec 1, 2011

    Outcome Measures

    Primary Outcome Measures

    1. Number of subjects with normal VEMP response [At the time of diagnosis of BPPV]

    Secondary Outcome Measures

    1. Number of subjects with recurrent BPPV in whom VEMP response was pathological [at the time of BPPV diagnosis]

    Other Outcome Measures

    1. no other outcome measures [no other outcome measure]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Age 18-60 years

    • Complaints of positional or positioning vertigo.

    • Presence of typical nystagmus for posterior canal BPPV in Dix Hallpike maneuver

    Exclusion Criteria:
    • Patient younger than 18 or older than 60 years of age.

    • Otoneurology bed-side examination reveals bilateral BPPV.

    • Audiometry and tympanometry show conductive hearing loss.

    • Signs of retrocochlear lesion or central vestibular pathology in bed-side otoneurological examination or audiometry or ENG/VNG.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Otoneurology Unit, Lin Medical Center, 35 Rotchild Avenue Haifa Israel 35152

    Sponsors and Collaborators

    • Meir Medical Center
    • Clalit Health Services, Haifa and West Galilee

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Meir Medical Center
    ClinicalTrials.gov Identifier:
    NCT01004913
    Other Study ID Numbers:
    • kehila106/109
    First Posted:
    Oct 30, 2009
    Last Update Posted:
    Feb 12, 2013
    Last Verified:
    Aug 1, 2011

    Study Results

    No Results Posted as of Feb 12, 2013