Prednisone Treatment for Vestibular Neuronitis

Condition(s) targeted: Vestibular Diseases; Vestibular Neuronitis

Intervention: Prednisone (Drug); Prednisone (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Carmel Medical Center

Official(s) and/or principal investigator(s):
Avi Shupak, MD, Principal Investigator, Affiliation: Carmel Medical Center and Clalit Health Services, Haifa and West Galilee
Itzhak Braverman, MD, Principal Investigator, Affiliation: Hillel Yaffe Medical Center
Avishai Golz, MD, Principal Investigator, Affiliation: Rambam Health Care Campus
Elhanan Greenberg, ND, Principal Investigator, Affiliation: Carmel Medical Center
Avi Shupak, MD, Study Chair, Affiliation: Carmel Medical Center and Clalit Health Services, Haifa and West Galilee

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.

Official title: Prednisone Treatment for Vestibular Neuronitis

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Clinical: The presence of static and dynamic nystagmus, positional and positioning nystagmus, and disequilibrium on bedside examination.

Secondary outcome:

Functional: Scores on the Dizziness Handicap Inventory questionnaires.

Laboratory: Caloric lateralization and directional preponderance on electro-oculography (EOG).

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Otoneurolgy Unit, Lin Medical Center, Clalit Health Services, Haifa 35152, Israel

Department of Otolaryngology Head and Neck Surgery, Carmel Medical Center, Haifa 34362, Israel

Unit of Otolaryngology Head and Neck Surgery, Hillel Yaffe Medical Center, Hadera 38100, Israel

Department of Otolaryngology Head and Neck Surgery, Rambam Medical Center, Haifa 31096, Israel

Related 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. No abstract available.

Starting date: September 2005
Ending date: May 2007
Last updated: November 4, 2007