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
  Purpose

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
Vertigo

Study Type: Observational
Study Design: 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).

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Number of subjects with normal VEMP response [ Time Frame: At the time of diagnosis of BPPV ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • no other outcome measures [ Time Frame: no other outcome measure ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: November 2009
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients suffering fron Benign Paroxysmal Positional Vertigo

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01004913

Locations
Israel
Otoneurology Unit, Lin Medical Center, 35 Rotchild Avenue
Haifa, Israel, 35152
Sponsors and Collaborators
Meir Medical Center
Clalit Health Services, Haifa and West Galilee
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01004913     History of Changes
Other Study ID Numbers: kehila106/109
Study First Received: October 29, 2009
Last Updated: February 11, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Meir Medical Center:
Benign paroxysmal positional vertigo
Vestibular evoked myogenic potentials
Sacculo-colic reflex

Additional relevant MeSH terms:
Vertigo
Dizziness
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensation Disorders

ClinicalTrials.gov processed this record on April 15, 2014