ClinicalTrials.gg
Status unknownNCT01231009Updated Nov 1, 2010

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

An Early Phase 1 interventional study of Corticosteroids and Vestibular exercises in Vestibular Neuritis, sponsored by Aristotle University Of Thessaloniki. Status unknown at 1 site in Greece. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2010-11-01.

Sponsored by Aristotle University Of Thessaloniki · Early Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Early Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Vestibular Neuritis

Browse trials for

03

In context

Vestibular Neuronitis

34 studies on the registry are indexed under Vestibular Neuronitis; 4 are open to participants now.

This study's planned enrollment of 40 is below the median of 50 across 27 interventional studies indexed under Vestibular Neuronitis.

Browse Vestibular Neuronitis studies →

Lead sponsor

Aristotle University Of Thessaloniki is the lead sponsor of 282 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with history of acute or sub-acute rotatory vertigo with postural imbalance, nausea and imbalance.
  • Horizontal-rotatory spontaneous nystagmus.

Exclusion criteria

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
  • in receiving
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    Corticosteroids

    Patients receive for 7 days intravenous corticosteroids, dexamethasone, and they continue receiving for 7 days corticosteroids per os

    Drug: Corticosteroids · Other: Vestibular exercises

  • Placebo comparator
    Vestibular exercises

    Patients perform for 15 days certain vestibular exercises under suspicion of an expert physiotherapist

    Drug: Corticosteroids · Other: Vestibular exercises

Interventions

  • DrugCorticosteroids

    Intravenous Dexamethasone, 8mg three times per day tapering down for 7 days Per os dexamethasone, 2mg per day tapering down for 7 days

  • OtherVestibular exercises

    Vestibular exercises in order to enhance vestibulo-ocular reflex for 15 days under the suspicion of physiotherapist

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 1 year

  2. Laboratory recovery of vestibular

    caloric test and vestibular evoked myogenic potentials

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • 1st ENT Department, AHEPA University Hospital
    Thessaloniki, 54636, Greece
    Recruiting
    • John Goudakos, MD, MSc · Principal investigator
    • Konstantinos Markou, MD, PhD · Sub investigator
    • Miltiadis Tsaligopoulos, MD, PhD · Sub investigator
08

References and documents

Publications

  • 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. PubMed 24604142 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2010, a primary completion of Jan 2012 and a completion of Jan 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 29, 2010
First posted
Nov 1, 2010
Start
Jan 2010
Primary completionEst.
Jan 2012
CompletionEst.
Jan 2013
Last update
Nov 1, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 1, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01231009
First posted
Nov 1, 2010
Start date
Jan 2010
Primary completion
Jan 2012 (estimated)
Completion
Jan 2013 (estimated)
Last update
Nov 1, 2010

Study contacts

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

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion