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Prednisone Treatment for Vestibular Neuronitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00271791
First Posted: January 4, 2006
Last Update Posted: November 6, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Clalit Health Services, Haifa and West Galilee
Hillel Yaffe Medical Center
Rambam Health Care Campus
University Health Network, Toronto
Information provided by:
Carmel Medical Center
  Purpose
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.

Condition Intervention Phase
Vestibular Diseases Vestibular Neuronitis Drug: Prednisone Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Prednisone Treatment for Vestibular Neuronitis

Resource links provided by NLM:


Further study details as provided by Carmel Medical Center:

Primary Outcome Measures:
  • Clinical: The presence of static and dynamic nystagmus, positional and positioning nystagmus, and disequilibrium on bedside examination. [ Time Frame: 12 months ]

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

Enrollment: 17
Study Start Date: September 2005
Study Completion Date: May 2007
Arms Assigned Interventions
Experimental: 1
Prednisone
Drug: Prednisone
PO, 1 mg/kg body weight, 5 days Short tapering regimen: daily reductions in the dose, 12 days
Placebo Comparator: 2
Placebo
Drug: Prednisone
PO, Placebo, 17 days

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00271791


Locations
Israel
Unit of Otolaryngology Head and Neck Surgery, Hillel Yaffe Medical Center
Hadera, Israel, 38100
Department of Otolaryngology Head and Neck Surgery, Rambam Medical Center
Haifa, Israel, 31096
Department of Otolaryngology Head and Neck Surgery, Carmel Medical Center
Haifa, Israel, 34362
Otoneurolgy Unit, Lin Medical Center, Clalit Health Services
Haifa, Israel, 35152
Sponsors and Collaborators
Carmel Medical Center
Clalit Health Services, Haifa and West Galilee
Hillel Yaffe Medical Center
Rambam Health Care Campus
University Health Network, Toronto
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
  More Information

Publications:
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.
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.
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.
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.
Bergenius J, Perols O. Vestibular neuritis: a follow-up study. Acta Otolaryngol. 1999;119(8):895-9.
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.
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.
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: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2000 Nov 28;55(10):1431-41. Review.

ClinicalTrials.gov Identifier: NCT00271791     History of Changes
Other Study ID Numbers: 42352
20050277
First Submitted: January 1, 2006
First Posted: January 4, 2006
Last Update Posted: November 6, 2007
Last Verified: July 2007

Keywords provided by Carmel Medical Center:
Vestibular Neuronitis
Vestibular Function Tests
Vestibular Adaptation
Steroids

Additional relevant MeSH terms:
Vestibular Diseases
Vestibular Neuronitis
Neuritis
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Vestibulocochlear Nerve Diseases
Retrocochlear Diseases
Cranial Nerve Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents


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