Prednisone Treatment for Vestibular Neuronitis

November 4, 2007 updated by: Carmel Medical Center
The purpose of the study is to investigate the value of steroids in the treatment of vestibular neuronitis. The potential benefits of steroid therapy would be analyzed by the clinical response, self-perceived handicap and laboratory parameters.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Vestibular neuronitis is the second most common cause of peripheral vestibulopathy (the first being benign paroxysmal positional vertigo) with incidence of about 3.5/100000. Currently vestibular neuronitis is explained by a viral pathogenesis.

Vestibular neuronitis is considered to have a benign course. The static rotatory vertigo and disequilibrium, present even when the patient is completely at rest, subside in most cases within a few days, and a gradual return to daily activities is the rule. However, it has been shown that there is generally incomplete restoration of peripheral function, and clinical recovery is achieved by proprioceptive and visual substitution for the unilateral vestibular deficit, combined with central vestibular compensation of the imbalance in vestibular tone. Although vestibular neuronitis is usually restricted to one attack, several studies have reported continuous or episodic vertigo or unsteadiness in 43% -53% of patients. The main residua include impaired vision and disequilibrium during walking and especially during head movement toward the affected ear. The rate of positive finding on vestibular evaluation may reach 60%. However, vestibular impairment as reflected by positive bedside testing and vestibular laboratory evaluation is not necessarily accompanied by subjective complaints and does not always reflect the level of incapacity.

The assumed HSV-1 etiology of vestibular neuronitis and the reported benefit of the combination of steroids and acyclovir in Bell's palsy suggest similar advantage in the treatment of vestibular neuronitis. Also, glucocorticoid receptors activation was reported to enhance vestibular compensation after acute peripheral vestibular insults in various animal models. A recent study investigated the effect of prednisolone versus valacyclovir and placebo on canal paresis in vestibular neuronitis patients. It was found that steroid treatment significantly improved peripheral vestibular function to the extent reflected by the caloric testing. However, bedside findings, patients' complaints and daily handicap were not evaluated. The relevance of the EOG caloric test results to clinical improvement could be argued in light of a previous report showing no correlation between EOG findings and residual symptoms in a long-term follow-up of vestibular neuronitis patients, and the finding that corticosteroid therapy had no effect on symptoms despite significant recovery of the caloric-test results.

The purpose of the study:

Prospective controlled longitudinal 12-month evaluation of the value of steroids in the treatment of vestibular neuronitis. The potential benefits of steroid therapy would be analyzed by the clinical response, self-perceived handicap and EOG laboratory parameters.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Hadera, Israel, 38100
        • Unit of Otolaryngology Head and Neck Surgery, Hillel Yaffe Medical Center
      • Haifa, Israel, 31096
        • Department of Otolaryngology Head and Neck Surgery, Rambam Medical Center
      • Haifa, Israel, 34362
        • Department of Otolaryngology Head and Neck Surgery, Carmel Medical Center
      • Haifa, Israel, 35152
        • Otoneurolgy Unit, Lin Medical Center, Clalit Health Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of vestibular neuronitis.
  • Documentation of unilateral reduced caloric response (caloric asymmetry >25%) on the EOG caloric study.

Exclusion Criteria:

  • Complaints of new hearing loss, tinnitus, or neurological deficits.
  • The presence of previously non-diagnosed sensorineural hearing loss (SNHL)
  • History of vestibular dysfunction.
  • Patient younger than 18 years of age.
  • Known contra-indication to systemic steroids: Unbalanced hypertension, un-controlled diabetes mellitus, immunodeficiency, active peptic disease, and avascular necrosis of the femoral head.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Placebo
Drug: Prednisone
PO, 1 mg/kg body weight, 5 days Short tapering regimen: daily reductions in the dose, 12 days
Drug: Prednisone
PO, Placebo, 17 days
Experimental: 1
Prednisone
Drug: Prednisone
PO, 1 mg/kg body weight, 5 days Short tapering regimen: daily reductions in the dose, 12 days
Drug: Prednisone
PO, Placebo, 17 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical: The presence of static and dynamic nystagmus, positional and positioning nystagmus, and disequilibrium on bedside examination.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Functional: Scores on the Dizziness Handicap Inventory questionnaires.
Time Frame: 12 months
12 months
Laboratory: Caloric lateralization and directional preponderance on electro-oculography (EOG).
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carmel Medical Center

Collaborators

University Health Network, Toronto
Rambam Health Care Campus
Hillel Yaffe Medical Center
Clalit Health Services, Haifa and West Galilee

Investigators

  • Principal Investigator: Avi Shupak, MD, Carmel Medical Center and Clalit Health Services, Haifa and West Galilee
  • Principal Investigator: Itzhak Braverman, MD, Hillel Yaffe Medical Center
  • Principal Investigator: Avishai Golz, MD, Rambam Health Care Campus
  • Principal Investigator: Elhanan Greenberg, ND, Carmel Medical Center
  • Study Chair: Avi Shupak, MD, Carmel Medical Center and Clalit Health Services, Haifa and West Galilee

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

January 1, 2006

First Submitted That Met QC Criteria

January 1, 2006

First Posted (Estimate)

January 4, 2006

Study Record Updates

Last Update Posted (Estimate)

November 6, 2007

Last Update Submitted That Met QC Criteria

November 4, 2007

Last Verified

July 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 42352
  • 20050277

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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