Back to resultsThe Role of Corticosteroids and Vestibular Exercises in Recovery of Vestibular Neuritis
Primary Purpose
Vestibular Neuritis
Status
Unknown status
Phase
Early Phase 1
Locations
Greece
Study Type
Interventional
Intervention
Corticosteroids
Vestibular exercises
Sponsored by
About this trial
This is an interventional treatment trial for Vestibular Neuritis
Eligibility 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
Sites / Locations
- 1st ENT Department, AHEPA University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Corticosteroids
Vestibular exercises
Arm Description
Patients receive for 7 days intravenous corticosteroids, dexamethasone, and they continue receiving for 7 days corticosteroids per os
Patients perform for 15 days certain vestibular exercises under suspicion of an expert physiotherapist
Outcomes
Primary Outcome Measures
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)
Laboratory recovery of vestibular
caloric test and vestibular evoked myogenic potentials
Secondary Outcome Measures
Full Information
NCT ID
NCT01231009
First Posted
October 29, 2010
Last Updated
October 29, 2010
Sponsor
Aristotle University Of Thessaloniki
1. Study Identification
Unique Protocol Identification Number
NCT01231009
Brief Title
The Role of Corticosteroids and Vestibular Exercises in Recovery of Vestibular Neuritis
Official Title
The Role of Corticosteroids and Vestibular Exercises in Recovery of Vestibular Neuritis: a Prospective Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
January 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Aristotle University Of Thessaloniki
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Neuritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Corticosteroids
Arm Type
Active Comparator
Arm Description
Patients receive for 7 days intravenous corticosteroids, dexamethasone, and they continue receiving for 7 days corticosteroids per os
Arm Title
Vestibular exercises
Arm Type
Placebo Comparator
Arm Description
Patients perform for 15 days certain vestibular exercises under suspicion of an expert physiotherapist
Intervention Type
Drug
Intervention Name(s)
Corticosteroids
Intervention Description
Intravenous Dexamethasone, 8mg three times per day tapering down for 7 days Per os dexamethasone, 2mg per day tapering down for 7 days
Intervention Type
Other
Intervention Name(s)
Vestibular exercises
Intervention Description
Vestibular exercises in order to enhance vestibulo-ocular reflex for 15 days under the suspicion of physiotherapist
Primary Outcome Measure Information:
Title
clinical recovery of vestibular function
Description
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)
Time Frame
1 year
Title
Laboratory recovery of vestibular
Description
caloric test and vestibular evoked myogenic potentials
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John Goudakos, MD, MSc
Phone
00306944183682
Email
jgoudakos@gmail.com
Facility Information:
Facility Name
1st ENT Department, AHEPA University Hospital
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Goudakos, MD, MSc
First Name & Middle Initial & Last Name & Degree
Konstantinos Markou, MD, PhD
First Name & Middle Initial & Last Name & Degree
Miltiadis Tsaligopoulos, MD, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
24604142
Citation
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.
Results Reference
derived
Learn more about this trial
The Role of Corticosteroids and Vestibular Exercises in Recovery of Vestibular Neuritis
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