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Trial registered on ANZCTR


Registration number
ACTRN12616000683437
Ethics application status
Approved
Date submitted
20/05/2016
Date registered
25/05/2016
Date last updated
28/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A Test of the Balance System in Vestibular Migraine
Scientific title
Diagnostic value of oVEMPs and cVEMPs in patients with vestibular migraine but without Meniere's disease
Secondary ID [1] 289264 0
None
Universal Trial Number (UTN)
UTN: U1111­1182­2889
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vestibular Migraine 298844 0
Condition category
Condition code
Neurological 298910 298910 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Both cervical VEMPs and ocular VEMPs will be measured in all participants at a Public Hospital by Jon Osborne, an Masters of Audiology student. Following placement of skin electrodes on the neck and below the eyes, the vestibular system will be stimulated using high level (starting at 100 dB HL before reducing intensity to determine threshold) 500 and 1000 Hz tone bursts via TDH headphones to each ear.

The rise and fall time of the tone burst will be set to 1 ms with a 2 ms plateau. The tone bursts will be presented at 10 Hz, and 256 repetitions will be used to produce a waveform (Lasting about 26 seconds).

Electromyography activity will be recorded using a CED 1902 bioamplifier and National Instruments USB6215 DAQ attached to a laptop. There are no known risks associated with VEMPs. However the sound levels may be uncomfortable.
All testing will be performed on one day, and will take less than an hour.

The cVEMPs and oVEMPs are not being compared directly.
Intervention code [1] 294810 0
Diagnosis / Prognosis
Comparator / control treatment
Healthy controls
Control group
Active

Outcomes
Primary outcome [1] 298380 0
cVEMP interpeak amplitude
Timepoint [1] 298380 0
All data is collected on one day for each participant.
Primary outcome [2] 298394 0
cVEMP latency
Timepoint [2] 298394 0
All data is collected on one day for each participant.
Primary outcome [3] 298395 0
cVEMP threshold
Timepoint [3] 298395 0
All data is collected on one day for each participant.
Secondary outcome [1] 323983 0
cVEMP prevalence (Primary)
Timepoint [1] 323983 0
All data is collected on one day for each participant.
Secondary outcome [2] 324013 0
oVEMP n10 amplitude (primary)
Timepoint [2] 324013 0
All data is collected on one day for each participant.
Secondary outcome [3] 324014 0
oVEMP latency (primary)
Timepoint [3] 324014 0
All data is collected on one day for each participant.
Secondary outcome [4] 324015 0
oVEMP threshold
Timepoint [4] 324015 0
All data is collected on one day for each participant.
Secondary outcome [5] 324016 0
oVEMP prevalence
Timepoint [5] 324016 0
All data is collected on one day for each participant.

Eligibility
Key inclusion criteria
For Vestibular Migraine group:

A. At least five episodes fulfilling criteria C and D
B. A current or past history of Migraine without aura or Migraine with aura
C. Vestibular symptoms of moderate or severe intensity, 3 lasting between 5 minutes and 72 hours
D. At least 50% of episodes are associated with at least one of the following three migrainous features:
1. headache with at least two of the following four characteristics:
a) unilateral location
b) pulsating quality
c) moderate or severe intensity
d) aggravation by routine physical activity
2. photophobia and phonophobia
3. visual aura
E. Not better accounted for by another ICHD-3 diagnosis or by another vestibular disorder.

The only criteria for the healthy controls are the exclusion criteria.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
For Vestibular Migraine

1. conductive hearing loss, determined by either pure tone audiometry or tympanometry.
2. inability to maintain tonic EMG neck activity by raising their head from a supine position
3. inability to maintain eye gaze in the superomedial direction.

For Healthy Controls:

Exclusion criteria for healthy controls:
1. significant history of balance/vertigo problems, or headache/migraine.
2. conductive hearing loss, determined by either pure tone audiometry or tympanometry.
3. inability to maintain tonic EMG neck activity by raising their head from a supine position
4. inability to maintain eye gaze in the superomedial direction.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
One-tailed t-tests with an alpha of 0.1 and power of 0.8 will be used. Corrections for multiple comparisons will not be made due to reduction of power. One-tailed t-tests are being used because an impairment of VEMP measures is typically in one direction.

Power analysis was performed using GPower 3.1 to determine sample size for one-tailed t-tests with a power of 0.8, alpha of 0.1 and effect size of 0.6 (based on previous literature of VEMPs in vestibular migraine). This gave an n of 26 per group.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Other reasons/comments
Other reasons
Equipment issues and delays
Date of first participant enrolment
Anticipated
1/06/2016
Actual
12/09/2016
Date of last participant enrolment
Anticipated
1/09/2016
Actual
12/10/2016
Date of last data collection
Anticipated
Actual
28/10/2016
Sample size
Target
52
Accrual to date
Final
24
Recruitment outside Australia
Country [1] 7891 0
New Zealand
State/province [1] 7891 0
Canterbury

Funding & Sponsors
Funding source category [1] 293645 0
University
Name [1] 293645 0
University of Canterbury
Country [1] 293645 0
New Zealand
Primary sponsor type
Individual
Name
Dr Rebecca KellyCampbell
Address
Communication Disorders Department
University of Canterbury
Private Bag 4800
Christchurch, 8140
Country
New Zealand
Secondary sponsor category [1] 292479 0
None
Name [1] 292479 0
None
Address [1] 292479 0
Country [1] 292479 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295082 0
Health and Disability Ethics Committee
Ethics committee address [1] 295082 0
Ethics committee country [1] 295082 0
New Zealand
Date submitted for ethics approval [1] 295082 0
05/05/2016
Approval date [1] 295082 0
17/05/2016
Ethics approval number [1] 295082 0
NZ/1/367A013

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66042 0
Mr Jonathan Robert Osborne
Address 66042 0
Private Bag 4800
Communication Disorders Department
University of Canterbury
Christchurch, 8140
Country 66042 0
New Zealand
Phone 66042 0
+64220820313
Fax 66042 0
Email 66042 0
jon.robert.osborne@gmail.com
Contact person for public queries
Name 66043 0
Jonathan Robert Osborne
Address 66043 0
Private Bag 4800
Communication Disorders Department
University of Canterbury
Christchurch, 8140
Country 66043 0
New Zealand
Phone 66043 0
+64220820313
Fax 66043 0
Email 66043 0
jon.robert.osborne@gmail.com
Contact person for scientific queries
Name 66044 0
Jonathan Robert Osborne
Address 66044 0
Private Bag 4800
Communication Disorders Department
University of Canterbury
Christchurch, 8140
Country 66044 0
New Zealand
Phone 66044 0
+64220820313
Fax 66044 0
Email 66044 0
jon.robert.osborne@gmail.com

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.