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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Aristotle University Of Thessaloniki.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:
NCT01231009
First received: October 29, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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 Intervention Phase
Vestibular Neuritis
Drug: Corticosteroids
Other: Vestibular exercises
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Aristotle University Of Thessaloniki:

Primary Outcome Measures:
  • clinical recovery of vestibular function [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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)

  • Laboratory recovery of vestibular [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    caloric test and vestibular evoked myogenic potentials


Estimated Enrollment: 40
Study Start Date: January 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Aristotle University Of Thessaloniki

Additional 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
Study First Received: October 29, 2010
Last Updated: October 29, 2010
Health Authority: Greece: Ethics Committee

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

ClinicalTrials.gov processed this record on August 20, 2014