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Trial registered on ANZCTR


Registration number
ACTRN12613001184763
Ethics application status
Not yet submitted
Date submitted
12/08/2013
Date registered
29/10/2013
Date last updated
29/10/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the efficacy of repetitive transcranial magnetic stimulation for people with Mal de Debarquement Syndrome
Scientific title
In patients with Mal de Debarquement Syndrome, does repetitive transcranial magnetic stimulation, compared to sham, reduce symptoms of imbalance and chronic rocking dizziness?
Secondary ID [1] 283005 0
Nil known
Universal Trial Number (UTN)
U1111-1146-6248
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mal de Debarquement Syndrome 289833 0
Condition category
Condition code
Neurological 290189 290189 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Individuals with Mal de Debarquement Syndrome (MdDS) will receive eight treatments of repetitive transcranial magnetic stimulation, twice per week for four weeks. Repetitive transcranial magnetic stimulation will be administered using a Magstim Rapidstim system with a 70 mm figure of eight air-cooled coil applied to the left dorsolateral pre-frontal cortex. To identify the correct region, patients will wear a snug fitted cap, fitted to individual anatomical landmarks (anteriorly at the glabella, posteriorly at the occipital protuberance and laterally at the external auditory meatus). The cap is pre-marked areas from the accepted 10-20 electroencephalography system with the left dorsolateral prefrontal cortex at region F3. The repetitive transcranial magnetic stimulation treatment will be at a frequency of 10 Hz, of 45 sets of 40 pulses per set (4 seconds duration per set) and a rest period per set of 26 seconds. Overall the duration of each visit will be 30 minutes (which includes patient set up).
Intervention code [1] 287718 0
Treatment: Devices
Comparator / control treatment
Sham repetitive transcranial magnetic stimulation will be applied to the left dorsolateral pre-frontal cortex. Sham treatment will be administered using a Magstim 70 mm figure of eight air-cooled sham coil that is identical in look, sound and percussion to a real 70 mm coil. However, the sham coil does not have any conducting material and does not induce any current.
Control group
Placebo

Outcomes
Primary outcome [1] 290217 0
Evaluation of balance using the miniBEST balance testing.
Timepoint [1] 290217 0
The miniBEST will be measured at the completion of the treatment (at 4 weeks), with follow up measurement at two, four and six weeks post completion of treatment (at time points six, eight and 10 weeks post baseline).
Secondary outcome [1] 304130 0
Motor evoked potentials (MEPs) as assessed by transcranial magnetic stimulation
Timepoint [1] 304130 0
MEPs will be will be measured at the completion of the treatment (at 4 weeks), with follow up measurement at two, four and six weeks post completion of treatment (at time points six, eight and 10 weeks post baseline).
Secondary outcome [2] 305221 0
Self reporting confidence in activities of daily living using the Activities of Balance Confidence (ABC) survey.
Timepoint [2] 305221 0
ABC survey will be undertaken at the completion of the treatment (at 4 weeks), with follow up measurement at two, four and six weeks post completion of treatment (at time points six, eight and 10 weeks post baseline).

Eligibility
Key inclusion criteria
These participants will be otherwise healthy but experience symptoms of a persistent sensation of motion usually described as rocking, swaying, or bobbing; and difficulty maintaining balance.
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children and/or young people <18 years, people with an intellectual or mental impairment, and people highly dependent on medical care or unable to communicate in English.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computer program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Due to the rarity of the condition, this study aims to use a convenience sample of 10-12 MdDS patients within a multiple case study format. Although power may not be sufficient, the study aims to use two-way repeated measures ANOVA (or non-parametric equivalent).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 7267 0
3125 - Burwood
Recruitment postcode(s) [2] 7268 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 287771 0
University
Name [1] 287771 0
In-kind and resources from Deakin University
Address [1] 287771 0
221 Burwood Highway
Burwood
Melbourne, Victoria 3125
Country [1] 287771 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Highway
Burwood
Melbourne, Victoria 3125
Country
Australia
Secondary sponsor category [1] 286498 0
None
Name [1] 286498 0
Address [1] 286498 0
Country [1] 286498 0
Other collaborator category [1] 277574 0
Charities/Societies/Foundations
Name [1] 277574 0
Mal de Debarquement Syndrome Foundation
Address [1] 277574 0
22406 Shannondell Drive
Audubon, PA 19403
Country [1] 277574 0
United States of America

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289720 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 289720 0
221 Burwood Highway
Burwood,
Melbourne, Victoria, 3125
Ethics committee country [1] 289720 0
Australia
Date submitted for ethics approval [1] 289720 0
20/11/2013
Approval date [1] 289720 0
Ethics approval number [1] 289720 0
TBC

Summary
Brief summary
Mal de Debarquement Syndrome is a rare condition whereby the person has continued perception of rocking and imbalance, usually occurring after a cruise, aircraft flight, or other sustained motion event. In many cases this continued perception of motion recedes after several hours or days. However in some cases persistent Mal de Debarquement Syndrome will last for years and decades. It has only recently received attention and very little scientific research has been conducted. However, the limited research to date has suggested that this condition is due to changes in excitability within the brain. The aim of this study is to investigate the efficacy of repetitive brain stimulation on people with Mal de Debarquement Syndrome. Individuals with this condition will receive eight sessions of repetitive brain stimulation, an established and safe technique, versus sham. Tests of brain excitability, balance testing, and self-reported perception of balance in daily activities will be undertaken prior to and at the end of the brain stimulation intervention, with self-reported perception of balance in daily activities followed up at six and eight weeks post intervention. It is hypothesised that those who received the real brain stimulation treatment will reduce symptoms in imbalance compared to those receiving sham. It is also hypothesised that brain excitability will reduce in those receiving the real treatment compared to sham treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42110 0
Dr Alan Pearce
Address 42110 0
C/- School of Psychology
Deakin University
221 Burwood Highway
Burwood
Melbourne, Victoria, 3125
Country 42110 0
Australia
Phone 42110 0
+61 3 9251 7224
Fax 42110 0
Email 42110 0
alan.pearce@deakin.edu.au
Contact person for public queries
Name 42111 0
Dr Alan Pearce
Address 42111 0
C/- School of Psychology
Deakin University
221 Burwood Highway
Burwood
Melbourne, Victoria, 3125
Country 42111 0
Australia
Phone 42111 0
+61 3 9251 7224
Fax 42111 0
Email 42111 0
alan.pearce@deakin.edu.au
Contact person for scientific queries
Name 42112 0
Dr Alan Pearce
Address 42112 0
C/- School of Psychology
Deakin University
221 Burwood Highway
Burwood
Melbourne, Victoria, 3125
Country 42112 0
Australia
Phone 42112 0
+61 3 9251 7224
Fax 42112 0
Email 42112 0
alan.pearce@deakin.edu.au

No information has been provided regarding IPD availability
Summary results
No Results