Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000941662
Ethics application status
Approved
Date submitted
7/08/2023
Date registered
31/08/2023
Date last updated
31/08/2023
Date data sharing statement initially provided
31/08/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Non-invasive Electrical Brain Stimulation for Cybersickness Prevention on Healthy Participants
Scientific title
The Effect of Transcranial Direct Current Stimulation on
Cybersickness in Healthy Adults
Secondary ID [1] 310303 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cybersickness 331002 0
Condition category
Condition code
Neurological 327814 327814 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There will be a 2 minute baseline seated rest recording of electroencephalogram (EEG) and a custom algorithm run straight after to predict cybersickness based on the EEG data. Afterwards if a positive prediction for cybersickness was observed, there will be immediate transition to application of high definition transcranial direct current stimulation applied at Cz for anodal, cathodal, anodal and sham, with surrounding return electrodes at Fc1, Fc2, Cp1, Cp2 (10-10 electrode system). Delivered at a safe 1.5mA for 5 minutes plus 30 second ramp up/down, once per day per stimulation type, for a total of 3 sessions, at least 24 hours apart as a washout period, which can be consecutive or non consecutive. Using a Neuroelectrics starstim32 hybrid stimulator, NG Pistim electrodes (p cm2Ag/AgCl/gel electrode, radius 1cm), stimulation delivered by experiment conductor. Sham only includes 30 second ramp up/down. After each 5 minute stimulation + 1 minute for the ramp up and down there will be a 10 minute VR immersion period, and a 2 minute recovery period. The entire duration of the session is anticipated to run for about 20 minutes including baseline recordings, stimulation, VR immersion, and recovery period . The intervention is given at Hercus building, 60 Hanover Street, Central Dunedin, Dunedin 9016.
Intervention code [1] 326683 0
Prevention
Comparator / control treatment
Sham treatment as described above includes no constant stimulation only 30s ramp up/down to 1.5mA to induce the same slight feeling on the scalp of stimulation. Active treatments such as cathodal and anodal currents can be considered an active sham of opposite polarities.
Control group
Active

Outcomes
Primary outcome [1] 335662 0
The number of cybersick episodes reported, indicated by a thumbs up.
Timepoint [1] 335662 0
The thumbs up was reported whenever a CS event is felt throughout the duration of VR immersion which is 10 minutes.
Primary outcome [2] 335875 0
The degree of severity for the cybersickness indicated by verbal report on a scale of 1-20 using the fast motion sickness (FMS) questionnaire.
Timepoint [2] 335875 0
Reported immediately after completion of the 10 minute VR immersion period.
Primary outcome [3] 335876 0
A post-experiment simulator sickness questionnaire (SSQ) validated for measuring symptoms of nausea, oculomotor problems and disorientation.
Timepoint [3] 335876 0
Reported at the end of the experiment after recovery period.
Secondary outcome [1] 425132 0
Relative cortical activation post stimulation in terms of importance of brain activity under EEG channels compared to all other channels, measured by converting EEG data into spike trains and spatially mapping this activity in a spiking neural network.
Timepoint [1] 425132 0
EEG data was recorded prior to VR immersion which is for 2 minutes during the baseline period and throughout VR immersion which is 10 minutes.

Eligibility
Key inclusion criteria
Without prior neurological, cardiovascular, gastrointestinal disease, and not on regular medication or drugs. Inclusion was further restricted only to those susceptible to cybersickness (CS). A score of 10 or above on the visually induced motion sickness questionnaire (VIMSSQ).
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
implanted devices, head implants containing metal (outside of mouth), head wound, skin condition on scalp, previous adverse reactions to tDCS, pregnancy.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
"Allocation is not concealed", all participants experienced all conditions in a within-subjects design.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A priori G. power calculations of sample size to achieve a power of 0.95 with an effect size of 0.95 at an alpha error probability of 0.05. N=20. Effect sizes calculated using Cohen's D, Relative Risk, Odds Ratio, and Fisher's exact test on succesful cybersickness preventions versus non-successful.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
28/04/2022
Date of last participant enrolment
Anticipated
Actual
14/12/2022
Date of last data collection
Anticipated
Actual
24/01/2023
Sample size
Target
20
Accrual to date
Final
19
Recruitment outside Australia
Country [1] 25689 0
New Zealand
State/province [1] 25689 0

Funding & Sponsors
Funding source category [1] 314514 0
University
Name [1] 314514 0
University of Otago
Country [1] 314514 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
60 Hanover Street, Central Dunedin, Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 316460 0
None
Name [1] 316460 0
Address [1] 316460 0
Country [1] 316460 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313556 0
University of Otago Human Ethics Committee
Ethics committee address [1] 313556 0
Ethics committee country [1] 313556 0
New Zealand
Date submitted for ethics approval [1] 313556 0
17/03/2022
Approval date [1] 313556 0
21/03/2022
Ethics approval number [1] 313556 0
H22/016

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

Contacts
Principal investigator
Name 128534 0
A/Prof Yusuf Cakmak
Address 128534 0
University of Otago, 60 Hanover Street, Central Dunedin, Dunedin 9016
Country 128534 0
New Zealand
Phone 128534 0
+64 2108797738
Fax 128534 0
Email 128534 0
[email protected]
Contact person for public queries
Name 128535 0
Yusuf Cakmak
Address 128535 0
University of Otago, 60 Hanover Street, Central Dunedin, Dunedin 9016
Country 128535 0
New Zealand
Phone 128535 0
+64 3 479 7362
Fax 128535 0
Email 128535 0
[email protected]
Contact person for scientific queries
Name 128536 0
Yusuf Cakmak
Address 128536 0
University of Otago, 60 Hanover Street, Central Dunedin, Dunedin 9016
Country 128536 0
New Zealand
Phone 128536 0
+64 3 479 7362
Fax 128536 0
Email 128536 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.