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

• ClinicalTrials.gov Identifier: NCT01004913
• Recruitment Status: Completed
• First Posted: October 30, 2009
• Last Update Posted: February 12, 2013
• Sponsor: Meir Medical Center
• Collaborator: Clalit Health Services, Haifa and West Galilee
• Information provided by (Responsible Party): Meir Medical Center

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
Vertigo

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: November 2009
• Actual Primary Completion Date: November 2011
• Actual Study Completion Date: December 2011

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Other Outcome Measures:

1. no other outcome measures [ Time Frame: no other outcome measure ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Meir Medical Center
• ClinicalTrials.gov Identifier: NCT01004913
• Other Study ID Numbers: kehila106/109
• First Posted: October 30, 2009
• Last Update Posted: February 12, 2013
• Last Verified: August 2011

Keywords provided by Meir Medical Center:

Benign paroxysmal positional vertigo; Vestibular evoked myogenic potentials; Sacculo-colic reflex

Additional relevant MeSH terms:

Vertigo; Benign Paroxysmal Positional Vertigo; Dizziness; Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Sensation Disorders