Study Results
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Basic Information
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COMPLETED
PHASE2
17 participants
INTERVENTIONAL
2005-09-30
2007-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Prednisone
Prednisone
PO, 1 mg/kg body weight, 5 days Short tapering regimen: daily reductions in the dose, 12 days
2
Placebo
Prednisone
PO, Placebo, 17 days
Interventions
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Prednisone
PO, 1 mg/kg body weight, 5 days Short tapering regimen: daily reductions in the dose, 12 days
Prednisone
PO, Placebo, 17 days
Eligibility Criteria
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Inclusion Criteria
* Documentation of unilateral reduced caloric response (caloric asymmetry \>25%) on the EOG caloric study.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Clalit Health Services, Haifa and West Galilee
OTHER
Hillel Yaffe Medical Center
OTHER_GOV
Rambam Health Care Campus
OTHER
University Health Network, Toronto
OTHER
Carmel Medical Center
OTHER
Principal Investigators
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Avi Shupak, MD
Role: PRINCIPAL_INVESTIGATOR
Carmel Medical Center and Clalit Health Services, Haifa and West Galilee
Itzhak Braverman, MD
Role: PRINCIPAL_INVESTIGATOR
Hillel Yaffe Medical Center
Avishai Golz, MD
Role: PRINCIPAL_INVESTIGATOR
Rambam Health Care Campus
Elhanan Greenberg, ND
Role: PRINCIPAL_INVESTIGATOR
Carmel Medical Center
Avi Shupak, MD
Role: STUDY_CHAIR
Carmel Medical Center and Clalit Health Services, Haifa and West Galilee
Locations
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Unit of Otolaryngology Head and Neck Surgery, Hillel Yaffe Medical Center
Hadera, , Israel
Department of Otolaryngology Head and Neck Surgery, Rambam Medical Center
Haifa, , Israel
Department of Otolaryngology Head and Neck Surgery, Carmel Medical Center
Haifa, , Israel
Otoneurolgy Unit, Lin Medical Center, Clalit Health Services
Haifa, , Israel
Countries
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References
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Strupp M, Zingler VC, Arbusow V, Niklas D, Maag KP, Dieterich M, Bense S, Theil D, Jahn K, Brandt T. Methylprednisolone, valacyclovir, or the combination for vestibular neuritis. N Engl J Med. 2004 Jul 22;351(4):354-61. doi: 10.1056/NEJMoa033280.
Ohbayashi S, Oda M, Yamamoto M, Urano M, Harada K, Horikoshi H, Orihara H, Kitsuda C. Recovery of the vestibular function after vestibular neuronitis. Acta Otolaryngol Suppl. 1993;503:31-4. doi: 10.3109/00016489309128067.
Ariyasu L, Byl FM, Sprague MS, Adour KK. The beneficial effect of methylprednisolone in acute vestibular vertigo. Arch Otolaryngol Head Neck Surg. 1990 Jun;116(6):700-3. doi: 10.1001/archotol.1990.01870060058010.
Arbusow V, Schulz P, Strupp M, Dieterich M, von Reinhardstoettner A, Rauch E, Brandt T. Distribution of herpes simplex virus type 1 in human geniculate and vestibular ganglia: implications for vestibular neuritis. Ann Neurol. 1999 Sep;46(3):416-9. doi: 10.1002/1531-8249(199909)46:33.0.co;2-w.
Bergenius J, Perols O. Vestibular neuritis: a follow-up study. Acta Otolaryngol. 1999;119(8):895-9. doi: 10.1080/00016489950180243.
Shupak A, Nachum Z, Stern Y, Tal D, Gil A, Gordon CR. Vestibular neuronitis in pilots: follow-up results and implications for flight safety. Laryngoscope. 2003 Feb;113(2):316-21. doi: 10.1097/00005537-200302000-00022.
Cameron SA, Dutia MB. Lesion-induced plasticity in rat vestibular nucleus neurones dependent on glucocorticoid receptor activation. J Physiol. 1999 Jul 1;518(Pt 1):151-8. doi: 10.1111/j.1469-7793.1999.0151r.x.
Fife TD, Tusa RJ, Furman JM, Zee DS, Frohman E, Baloh RW, Hain T, Goebel J, Demer J, Eviatar L. Assessment: vestibular testing techniques in adults and children [RETIRED]: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2000 Nov 28;55(10):1431-41. doi: 10.1212/wnl.55.10.1431. No abstract available.
Other Identifiers
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20050277
Identifier Type: -
Identifier Source: secondary_id
42352
Identifier Type: -
Identifier Source: org_study_id