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

This study has been completed.
Sponsor:
Collaborator:
Clalit Health Services, Haifa and West Galilee
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01004913
First received: October 29, 2009
Last updated: February 11, 2013
Last verified: August 2011

October 29, 2009
February 11, 2013
November 2009
November 2011   (final data collection date for primary outcome measure)
Number of subjects with normal VEMP response [ Time Frame: At the time of diagnosis of BPPV ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01004913 on ClinicalTrials.gov Archive Site
Number of subjects with recurrent BPPV in whom VEMP response was pathological [ Time Frame: at the time of BPPV diagnosis ] [ Designated as safety issue: No ]
Not Provided
no other outcome measures [ Time Frame: no other outcome measure ] [ Designated as safety issue: No ]
Not Provided
 
Vestibular Evoked Myogenic Potentials in Benign Paroxysmal Positional Vertigo (VEMP in BPPV)
Evaluation of the Otolithic Organs Function in Patients Suffering From Benign Paroxysmal Positional Vertigo (BPPV) by Vestibular Evoked Myogenic Potentials (VEMP).

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

Patients suffering fron Benign Paroxysmal Positional Vertigo

Vertigo
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2011
November 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01004913
kehila106/109
No
Meir Medical Center
Meir Medical Center
Clalit Health Services, Haifa and West Galilee
Not Provided
Meir Medical Center
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP