Prednisone Treatment for Vestibular Neuronitis

Vestibular Diseases Clinical Trial

Official title:

Prednisone Treatment for Vestibular Neuronitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00271791
• Other study ID #: 42352
• Secondary ID: 20050277
• Status: Completed
• Phase: Phase 2
• First received: January 1, 2006
• Last updated: November 4, 2007
• Start date: September 2005
• Est. completion date: May 2007

Study information

• Verified date: July 2007
• Source: Carmel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vestibular Diseases
• Vestibular Neuronitis

Intervention

Drug:
• Prednisone
PO, 1 mg/kg body weight, 5 days Short tapering regimen: daily reductions in the dose, 12 days
• Prednisone
PO, Placebo, 17 days

Locations

Country	Name	City	State
Israel	Unit of Otolaryngology Head and Neck Surgery, Hillel Yaffe Medical Center	Hadera
Israel	Department of Otolaryngology Head and Neck Surgery, Carmel Medical Center	Haifa
Israel	Department of Otolaryngology Head and Neck Surgery, Rambam Medical Center	Haifa
Israel	Otoneurolgy Unit, Lin Medical Center, Clalit Health Services	Haifa

Sponsors (5)

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

Country where clinical trial is conducted

Israel, 

References & Publications (8)

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. — View Citation

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. — View Citation

Bergenius J, Perols O. Vestibular neuritis: a follow-up study. Acta Otolaryngol. 1999;119(8):895-9. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical: The presence of static and dynamic nystagmus, positional and positioning nystagmus, and disequilibrium on bedside examination.		12 months
Secondary	Functional: Scores on the Dizziness Handicap Inventory questionnaires.		12 months
Secondary	Laboratory: Caloric lateralization and directional preponderance on electro-oculography (EOG).		12 months