The Role of Corticosteroids and Vestibular Exercises in Recovery of Vestibular Neuritis

The Role of Corticosteroids and Vestibular Exercises in Recovery of Vestibular Neuritis: a Prospective Randomized Controlled Clinical Trial

Aim of present study is to determine whether corticosteroids and vestibular exercises are equal effective in the recovery of balance in patients with acute vestibular neuritis.

Study Overview

• Status: Unknown
• Conditions: Vestibular Neuritis
• Intervention / Treatment: Drug: Corticosteroids; Other: Vestibular exercises

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: John Goudakos, MD, MSc; Phone Number: 00306944183682; Email: jgoudakos@gmail.com

Study Locations

• Greece
  • Thessaloniki, Greece, 54636
    • Recruiting
    • 1st ENT Department, AHEPA University Hospital
    • Principal Investigator: John Goudakos, MD, MSc
    • Sub-Investigator: Konstantinos Markou, MD, PhD
    • Sub-Investigator: Miltiadis Tsaligopoulos, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with history of acute or sub-acute rotatory vertigo with postural imbalance, nausea and imbalance.
• Horizontal-rotatory spontaneous nystagmus.

Exclusion Criteria:

• History of vestibular disfunction before the acute onset of symptoms
• Simultaneous Hearing loss
• Neurologic disorder
• Pregnancy or lactation
• History of psychiatric disorders
• History of glaucoma
• Diabetes
• Hypertension
• Contraindication in receiving corticosteroids

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Corticosteroids; Patients receive for 7 days intravenous corticosteroids, dexamethasone, and they continue receiving for 7 days corticosteroids per os	Drug: Corticosteroids; Intravenous Dexamethasone, 8mg three times per day tapering down for 7 days Per os dexamethasone, 2mg per day tapering down for 7 days; Other: Vestibular exercises; Vestibular exercises in order to enhance vestibulo-ocular reflex for 15 days under the suspicion of physiotherapist
Placebo Comparator: Vestibular exercises; Patients perform for 15 days certain vestibular exercises under suspicion of an expert physiotherapist	Drug: Corticosteroids; Intravenous Dexamethasone, 8mg three times per day tapering down for 7 days Per os dexamethasone, 2mg per day tapering down for 7 days; Other: Vestibular exercises; Vestibular exercises in order to enhance vestibulo-ocular reflex for 15 days under the suspicion of physiotherapist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical recovery of vestibular function	clinical examination (nystagmus, Romberg test, head-thrust test, head-shaking test) and questionnaires (Greek edition of Dizziness Handicap Inventory and European Evaluation of Vertigo Scale)	1 year
Laboratory recovery of vestibular	caloric test and vestibular evoked myogenic potentials	1 year

Collaborators and Investigators

• Sponsor: Aristotle University Of Thessaloniki

Publications and helpful links

General Publications

• Goudakos JK, Markou KD, Psillas G, Vital V, Tsaligopoulos M. Corticosteroids and vestibular exercises in vestibular neuritis. Single-blind randomized clinical trial. JAMA Otolaryngol Head Neck Surg. 2014 May;140(5):434-40. doi: 10.1001/jamaoto.2014.48.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Anticipated): January 1, 2012
• Study Completion (Anticipated): January 1, 2013

Study Registration Dates

• First Submitted: October 29, 2010
• First Submitted That Met QC Criteria: October 29, 2010
• First Posted (Estimate): November 1, 2010

Study Record Updates

• Last Update Posted (Estimate): November 1, 2010
• Last Update Submitted That Met QC Criteria: October 29, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Otorhinolaryngologic Diseases; Peripheral Nervous System Diseases; Ear Diseases; Cranial Nerve Diseases; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Neuritis; Vestibular Neuronitis
• Other Study ID Numbers: VN-01-JG