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Comparing portable and reference system for evaluating brain electrical activity

Comparison of portable Visual Evoked Potential devices with reference EEG systems on Healthy Participants

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001347257
Enrollment
20
Registered
2018-08-09
Start date
2018-08-07
Completion date
2018-08-17
Last updated
2018-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

HeadsafeIP Pty Ltd
Lead SponsorCommercial sector/Industry

Study design

Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Adults aged at least 18, and be able to read, understand, and provide a signed informed consent form.

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026