The Role of Corticosteroids and Vestibular Exercises in Recovery of Vestibular Neuritis - Full Text View

Sponsor:	Aristotle University Of Thessaloniki
Information provided by:	Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier:	NCT01231009

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:

MedlinePlus related topics: Exercise and Physical Fitness

U.S. FDA Resources

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

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

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 May 23, 2012