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

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ClinicalTrials.gov Identifier: NCT01231009
Recruitment Status : Unknown
Verified January 2010 by Aristotle University Of Thessaloniki.
Recruitment status was:  Recruiting
First Posted : November 1, 2010
Last Update Posted : November 1, 2010
Sponsor:
Information provided by:
Aristotle University Of Thessaloniki

Brief 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.

Condition or disease Intervention/treatment Phase
Vestibular Neuritis Drug: Corticosteroids Other: Vestibular exercises Early Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of Corticosteroids and Vestibular Exercises in Recovery of Vestibular Neuritis: a Prospective Randomized Controlled Clinical Trial
Study Start Date : January 2010
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. clinical recovery of vestibular function [ Time Frame: 1 year ]
    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)

  2. Laboratory recovery of vestibular [ Time Frame: 1 year ]
    caloric test and vestibular evoked myogenic potentials



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01231009


Contacts
Contact: John Goudakos, MD, MSc 00306944183682 jgoudakos@gmail.com

Locations
Greece
1st ENT Department, AHEPA University Hospital Recruiting
Thessaloniki, Greece, 54636
Principal Investigator: John Goudakos, MD, MSc         
Sub-Investigator: Konstantinos Markou, MD, PhD         
Sub-Investigator: Miltiadis Tsaligopoulos, MD, PhD         
Sponsors and Collaborators
Aristotle University Of Thessaloniki

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: 1st ENT Department, AHEPA University Hospital, John Goudakos, Research fellow
ClinicalTrials.gov Identifier: NCT01231009     History of Changes
Other Study ID Numbers: VN-01-JG
First Posted: November 1, 2010    Key Record Dates
Last Update Posted: November 1, 2010
Last Verified: January 2010

Additional relevant MeSH terms:
Neuritis
Vestibular Neuronitis
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Vestibulocochlear Nerve Diseases
Retrocochlear Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Cranial Nerve Diseases