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Trial registered on ANZCTR


Registration number
ACTRN12618001347257
Ethics application status
Approved
Date submitted
6/08/2018
Date registered
9/08/2018
Date last updated
25/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparing portable and reference system for evaluating brain electrical activity
Scientific title
Comparison of portable Visual Evoked Potential devices with reference EEG systems on Healthy Participants
Secondary ID [1] 295690 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain injury 309065 0
Condition category
Condition code
Neurological 307949 307949 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The investigational device (a portable steady-state visual-evoked potential (SSVEP)/EEG headset) will be evaluated on participants to acquire their SSVEP. This involves fitting the headset to participant's head and applying saline solution to the contact electrodes to acquire good contact with the participant. A smartphone will be used to control the investigational device only. In addition, a reference-type EEG system will also be used for comparison purposes.

Both systems will be fitted by a trained researcher at the principal investigator's nominated site. The order of the system assessed will be alternated based on their subject ID's: odd numbered ID's will have the investigational device fitted first, and vice-versa. The procedures will be performed individually.

Both systems will be on the head for approximately 5-10 minutes. Participants will be asked to sit still while having the systems on their head.

During the procedure, they will be asked to view a flashing light for 30 seconds: this flashing light will come from the investigational device. When the reference system is on the participant's head, they will be asked to hold up the investigational device to their eyes without the back of the device fitted to their head. In total, 4 sequences will be performed (2 viewings of the flashing light for the reference and investigational device each).

The procedure will last for approximately 30 minutes in total. No follow-up will be required.
Intervention code [1] 302008 0
Diagnosis / Prognosis
Comparator / control treatment
The reference-type device will be used as the comparator for the investigational device. The reference device will be a Compumedics Grael EEG system, which is an ARTG-registered medical device.
Control group
Active

Outcomes
Primary outcome [1] 306924 0
Primary outcome is the percentage of people who have a detected SSVEP for either system as per the criteria. The criteria is as follows:

• If the main peak between 5-35Hz is 15±0.1Hz, and
• If the Z-score of the main peak is above 5

The Z-score will be used as the primary indicator for the strength of the participant’s response to the visual stimuli. The Z-score will be calculated by evaluating the number of standard deviations the peak response is from the average noise amplitude. This Z-score for the peak response will be used to classify each individual as having a normal SSVEP. The noise will be measured from 5-30Hz.

Peak analysis on data transformed with the Fast Fourier Transform will be performed to confirm the frequency of the peak.

The Z-score will be analysed from 2 sources:
a) Data recorded from the reference EEG system and then analysed in MATLAB.
b) Data retrieved from the investigational device and then analysed in MATLAB. This will be performed identically to a).
Timepoint [1] 306924 0
Measurement date (T = 0). Single session only.
Secondary outcome [1] 350127 0
Number of individual device related adverse events. This will be assessed via direct observations.
Timepoint [1] 350127 0
Measurement date (T = 0). Single session only.
Secondary outcome [2] 350128 0
Assessment of device deficiencies. Every device deficiency will be recorded in the case-report form and analysed after the trial. Examples of device deficiency include application crashes, hardware failure and inability to achieve sufficient contact quality.
Timepoint [2] 350128 0
Measurement date (T = 0). Single session only.
Secondary outcome [3] 350129 0
Repeatability of tests between the same system. This will be derived from the data collected from patients, and analysed through software.
Timepoint [3] 350129 0
Measurement date (T = 0). Single session only.
Secondary outcome [4] 350130 0
Comparison between SSVEP data processed from the smartphone vs. raw SSVEP data processed in MATLAB. This comparison will verify the accuracy of processing between both the systems.
Timepoint [4] 350130 0
Measurement date (T = 0). Single session only.

Eligibility
Key inclusion criteria
Adults aged at least 18, and be able to read, understand, and provide a signed informed consent form.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• History of epileptic/seizure diagnoses and associated symptoms (characterised colloquially to participants as “fits, faints and funny turns”)
• Existing structural and/or functional brain diseases
• Existing headaches, migraines or eyesore

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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The null hypothesis is that the classification of the amplitude profiles as either normal or non-normal, by both methods will be the same. It is anticipated that all 20 of these healthy individuals will be categorised as having normal non-impaired SSVEP profiles but this result is not required to show perfect agreement between the two methods. The agreement between the two methods will be summarised as the number out of 20 (%) where both methods produce the same classification of the participant. An exact 95% confidence interval for this percentage will be calculated.

An independent biostatistician will conduct the statistical analysis of the data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/08/2018
Date of last participant enrolment
Anticipated
16/08/2018
Actual
17/08/2018
Date of last data collection
Anticipated
23/08/2018
Actual
17/08/2018
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 23564 0
2121 - Epping

Funding & Sponsors
Funding source category [1] 300272 0
Commercial sector/Industry
Name [1] 300272 0
HeadsafeIP Pty Ltd
Country [1] 300272 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
HeadsafeIP Pty Ltd
Address
PO Box 509
Bondi 2026
Country
Australia
Secondary sponsor category [1] 299704 0
None
Name [1] 299704 0
Address [1] 299704 0
Country [1] 299704 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301088 0
Bellberry Human Research Ethics Committee A (EC00372)
Ethics committee address [1] 301088 0
129 Glen Osmond Rd
Eastwood SA 5063
Ethics committee country [1] 301088 0
Australia
Date submitted for ethics approval [1] 301088 0
20/06/2018
Approval date [1] 301088 0
02/08/2018
Ethics approval number [1] 301088 0
2018-07-510

Summary
Brief summary
Visual evoked potentials (VEP) are a measurable brain signal as a response to a visual stimulus. VEPs assess the integrity of the visual pathway of the brain. Conventionally, these systems are not portable, relying on bulky cathode-ray tube displays and electroencephalography (EEG) systems. This investigational device is a portable implementation of a VEP system, allowing for use in non-clinical environments.

The study intends to verify and validate the SSVEPs of twenty healthy participants using two systems: the investigational device, and a reference EEG system. It is hypothesised that the VEPs may be obtained from both “standard” and portable systems with similar sensitivity and specificity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85842 0
Dr Craig Donaldson
Address 85842 0
Epping Surgery Centre
Suite 3, Oxford Place
44-46 Oxford Street, Epping NSW 2121
Country 85842 0
Australia
Phone 85842 0
+61 02 9868 2333
Fax 85842 0
Email 85842 0
[email protected]
Contact person for public queries
Name 85843 0
Adrian Cohen
Address 85843 0
HeadsafeIP Pty Ltd
PO Box 509,
Bondi, NSW 2024
Country 85843 0
Australia
Phone 85843 0
+61 418 253 333
Fax 85843 0
Email 85843 0
[email protected]
Contact person for scientific queries
Name 85844 0
Adrian Cohen
Address 85844 0
HeadsafeIP Pty Ltd
PO Box 509,
Bondi, NSW 2024
Country 85844 0
Australia
Phone 85844 0
+61 418 253 333
Fax 85844 0
Email 85844 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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