Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000777998
Ethics application status
Approved
Date submitted
14/02/2011
Date registered
25/07/2011
Date last updated
25/07/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Results of serial assessment of eye movement recovery in patients with acute vertigo (labyrinthitis)
Scientific title
Serial assessment of the hypoactive Vestibular ocular reflex in patients with acute labyrinthine dysfunction
Secondary ID [1] 253601 0
Nil
Universal Trial Number (UTN)
The Universal Trial Number (UTN) is U1111-1119-4479
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute labyrinthitis 261161 0
Condition category
Condition code
Neurological 259315 259315 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Measurement of the hypoactive vestibular ocular reflex (VOR) by videooculography

Patients with clinical features of acute labyrinthitis will be seen in casualty within 24hrs of their symptom onset of acute vertigo. The head impulse test measures the eye movement response of a hypoactive VOR to a high acceleration head impulse when the examiner moves the subjects head with brief random head thrusts in the angular plane. It is hoped that approximately 12 random head impulse tests will be able to be assessed to the ipsilateral and contralateral side, depending on patient compliance and acceptability. The abnormal VOR will be monitored serially with videooculography with repeat testing in a 20 minute session to assess recovery on six occasions over a period of up to 3 months.
Intervention code [1] 258114 0
Not applicable
Intervention code [2] 267038 0
Rehabilitation
Comparator / control treatment
Normal controls

A normal historical control group (including age matched subjects from 20 to 80 years) without vestibular symptoms will be used as a baseline to establish both a normal quantitative value of the VOR gain (peak eye velocity/peak head velcoity)during the head impulse test as well as assessing what proportion of such subjects use catchup saccades. Such subjects will be seen on one occasion only in a 20 minute session. Five subjects for each decade will be recorded. Again approximately 12 random head impulse tests will be assessed to the ipsilateral and contralateral side, depending on patient compliance and acceptability.
Control group
Active

Outcomes
Primary outcome [1] 262119 0
Measurement of the hypoactive VOR with serial video oculography.

This will be assessed on the basis of measurement of the gain of eye velocity/head velocity at 40 and 80 ms after the onset of head rotation. Interruption of the VOR by catch up saccades will also be noted when these occur during the head impulse test (covert saccades) as well as those occurring after the head impulse test has been completed (overt saccades). The primary aspect of the serial study will be to observe how quickly patients utilise the two different forms of catchup saccades to improve their function.
Timepoint [1] 262119 0
Within 24hrs of presentation of the labyrinthitis and serially at 48-72 hours, 7 days, 14 days and 90 days. .
Secondary outcome [1] 273196 0
Affected patients may have an easily elictable abnormality of the head impulse acutely that may not be readily detected when the same test is performed two weeks later . This may reflect an acute partial lesion with recovery or a complete lesion with recovery over time or the presence of covert saccades which give the appearance of a false negative result with the head impulse test. Serial assessment of the recovery of the head impulse test over time will distinguish these different possibilities.
Timepoint [1] 273196 0
Serial studies will be done at the time of presentation (within 24 hours), 48-72 hours, 7 days, 14 days and 90 days.
Secondary outcome [2] 273197 0
Usefulness of education to casualty staff in the accuracy of diagnosis of acute labyrinitis. This will be assessed on the basis of the the referring physician committing on the electronic clinical record to their diagnosis and management - with and without specialist neurological input.
Timepoint [2] 273197 0
On completion of the study with the expected accrual of 12 patients
Secondary outcome [3] 273283 0
Correlation of the oculomotor abnormalities of the VOR noted on the head impulse test with measurements of clinical recovery as assessed by tests of perceptual function and a dizziness behavioural inventory.
Timepoint [3] 273283 0
Serial studies will be done at the time of presentation (within 24 hours), 48-72 hours, 7 days, 14 days and 90 days.
Secondary outcome [4] 273284 0
The sensitivity of the head impulse test performed at 72hours to a caloric test measured in the standard manner.
Timepoint [4] 273284 0
72 hours when acute dizziness has settled.

Eligibility
Key inclusion criteria
Patients with the clinical picture of acute labyrinthitis
Minimum age
10 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are too ill to be examined by video oculography

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment outside Australia
Country [1] 3196 0
New Zealand
State/province [1] 3196 0

Funding & Sponsors
Funding source category [1] 258496 0
Hospital
Name [1] 258496 0
Capital and Coast health
Country [1] 258496 0
New Zealand
Primary sponsor type
Hospital
Name
Capital and Coast health
Address
Private Bag 7902
Riddiford Street
Newtown
Wellington 6242
Country
New Zealand
Secondary sponsor category [1] 257633 0
None
Name [1] 257633 0
Address [1] 257633 0
Country [1] 257633 0
Other collaborator category [1] 251815 0
Individual
Name [1] 251815 0
Dr Nick Cutfield
Address [1] 251815 0
Dept Neurology Dunedin Hospital Dunedin 9054
Country [1] 251815 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260555 0
Multi-region Ethics Committee
Ethics committee address [1] 260555 0
Ethics committee country [1] 260555 0
New Zealand
Date submitted for ethics approval [1] 260555 0
01/03/2011
Approval date [1] 260555 0
25/05/2011
Ethics approval number [1] 260555 0
Ethics Red MEC/11/05/051

Or 336531 ANZTR no
Ethics committee name [2] 269476 0
Health and Disability Ethics Committees
Ethics committee address [2] 269476 0
PO BOx 5013 Wellington
Ethics committee country [2] 269476 0
New Zealand
Date submitted for ethics approval [2] 269476 0
Approval date [2] 269476 0
Ethics approval number [2] 269476 0

Summary
Brief summary
The primary purpose of the study is to observe the compensatory strategies that the brain uses to recover from acute labyrinthitis.

It is proposed that in patients with a partial labyrinthitis there may be a complete and early recovery of their eye movements generated by the inner ear. That is, the normal eye velocity generated by balance receptors in the inner ear should match the head velocity signal in a short period of time of seven days. Secondly it is proposed that the compensatory brain mechanisms used following acute labyrinthitis with rapid catch up eye movements (covert saccades) will occur within the first 24-48 hours of presentation.
Trial website
Trial related presentations / publications
MOSSMAN S. HALMAGYI GM.
Partial ocular tilt reaction due to unilateral cerebellar lesion.
Neurology. 49(2):491-3, 1997 Aug.

WESTWATER H. MCDOWALL J. SIEGERT R. MOSSMAN S. ABERNETHY D. Implicit learning in Parkinson's disease: evidence from a verbal version of the serial reaction time task. [Clinical Trial. Journal Article] Journal of Clinical & Experimental Neuropsychology: Official Journal of the International Neuropsychological Society. 20(3):413-8, 1998 Jun.

ROSEMERGY I, MOSSMAN S Brainstem lesions presenting with nausea and vomiting New Zealand Medical Journal Vol 120 No 1254;1-4 May 2007

Presentations

MOSSMAN S, LAWN N, LAI M, BHARA A, LAWSON C, CORBETT M A randomised controlled trial of a canal repositioning procedure in the treatment of BPPV World Congress of Neurology London 2001 (Poster P0654) J of the Neurological Sciences vol 187 S1, June 15 2001

MOSSMAN S, FITZJOHN T Asymptomatic cerebellar infarcts World Congress of Neurology London 2001 (Poster P0663) J of the Neurological Sciences vol 187 S1, June 15 2001

ANDERSON T, MacASKILL M, MOSSMAN S, BRONSTEIN A Saccadic downpulsion and cerebellar disease Paper presented at the Xth European Conference on Eye Movements, Utrecht, Holland

MOSSMAN S MEURS L Hypoactive VOR gain with infrared oculography P4-11Barany Society Kyoto Japan 2008

MOSSMAN S Covert short latency saccades in combined vestibular and cerebellar failure
Barany Soc Meeting J Vestibular Research PC-90 Vol 20, numbers 3,4 2010

SCHMULEWICZ D et al., Neuropathy is an intergral component of the cerebellar ataxia neuropathy vestibular areflexia syndrome (CANVAS) C3-6 J Vestibular Research Vol 20, numbers 3,4 2010
Public notes

Contacts
Principal investigator
Name 32209 0
Address 32209 0
Country 32209 0
Phone 32209 0
Fax 32209 0
Email 32209 0
Contact person for public queries
Name 15456 0
Stuart Mossman
Address 15456 0
Capital Coast health
Wellington Hospital
Private Bag 7902
Newtown
Wellington 6242
Country 15456 0
New Zealand
Phone 15456 0
+6443855999
Fax 15456 0
Email 15456 0
[email protected]
Contact person for scientific queries
Name 6384 0
Stuart Mossman
Address 6384 0
Capital Coast health
Wellington Hospital
Private Bag 7902
Newtown
Wellington 6242
Country 6384 0
New Zealand
Phone 6384 0
+6443855999
Fax 6384 0
Email 6384 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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