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Prednisone Treatment for Vestibular Neuronitis

Prednisone Treatment for Vestibular Neuronitis

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00271791
Enrollment
17
Registered
2006-01-04
Start date
2005-09-30
Completion date
2007-05-31
Last updated
2007-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vestibular Diseases, Vestibular Neuronitis

Keywords

Vestibular Neuronitis, Vestibular Function Tests, Vestibular Adaptation, Steroids

Brief summary

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.

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.

Interventions

DRUGPrednisone

PO, 1 mg/kg body weight, 5 days Short tapering regimen: daily reductions in the dose, 12 days

Sponsors

Clalit Health Services, Haifa and West Galilee
CollaboratorOTHER
Hillel Yaffe Medical Center
CollaboratorOTHER_GOV
Rambam Health Care Campus
CollaboratorOTHER
University Health Network, Toronto
CollaboratorOTHER
Carmel Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Clinical: The presence of static and dynamic nystagmus, positional and positioning nystagmus, and disequilibrium on bedside examination.12 months

Secondary

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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026