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

Vestibular Neuritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01231009
• Other study ID #: VN-01-JG
• Status: Recruiting
• Phase: Phase 0
• First received: October 29, 2010
• Last updated: October 29, 2010
• Start date: January 2010
• Est. completion date: January 2013

Study information

• Verified date: January 2010
• Source: Aristotle University Of Thessaloniki
• Contact: John Goudakos, MD, MSc
• Phone: 00306944183682
• Email: jgoudakos[@]gmail.com
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2013
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuritis
• Vestibular Neuritis
• Vestibular Neuronitis

Intervention

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

Locations

Country	Name	City	State
Greece	1st ENT Department, AHEPA University Hospital	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Laboratory recovery of vestibular	caloric test and vestibular evoked myogenic potentials	1 year	No