Health TrialsbyHealthPanel

NeuroCatch Reference Interval Database

ConditionsHealthy ControlsBrain Function
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6+
SponsorHealthTech Connex Inc.

About this trial

The purpose of this study is to understand how the brain responds to sounds and words, and how this response varies between individuals. The purpose if this study is to develop data set comparing the results from one individual with those from other members (a reference interval database of NeuroCatch® Platform 2) and to quantify the expected distribution across sex and age. NeuroCatch® Platform 2, is a medical device approved by Health Canada. The plan is to enroll 810 participants, the study includes screening for eligibility and one brain scan. The study is conducted at the Centre for Neurology Studies in Surrey, BC or at its satellite sites ( if required).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Any sex, at least 6 years of age or older

Able to understand the informed consent/assent form (in English), study procedures and willing to participate in study; participants under 19 must also have a parent/guardian who is able to understand and provide informed consent on their behalf.

Able to remain seated and focused for 7 minutes

In good health with no history of clinically relevant neurological illness or injury

Disqualifiers

Requires the use of hearing aids or a cochlear implant, diagnosed with tinnitus that is currently active, or has temporary damage to hearing (e.g., punctured ear drum). Or unable to detect a 740Hz tone played at 85dB in both ears.

Implanted pacemaker or other electrical stimulator(s)

Metal or plastic implants in the skull, excluding dental/facial implants.

Not native-level in English

Trial design

Design model

Single group

Treatments tested in this trial

  • NeuroCatch® Platform 2

    Device

    The NeuroCatch® Platform 2, a medical device system developed by NeuroCatch Inc., consists of software and hardware that captures brain health information. The platform intends to provide a quick, portable and easy to use solution for the acquisition, display, analysis, storage, reporting and management of electroencephalograph (EEG) and event-related potential (ERP; brain response to a stimulus) information. The device is approved as a medical device by Health Canada.

Treatment groups

810 Participants
are divided into 1 treatment group
Group A: NeuroCatch® Platform 2Other 1 intervention

Trial outcomes

Primary outcomes

1

Amplitude & Latency collection for NeuroCatch® Platform 2

Response size (amplitude in microvolts) and response timing (latency in milliseconds) will be collected for the ERPs N100, P300 and N400.

Time frame
20 minutes
2

Demographic indicators

Demographic indicators to be collected such as year of birth, sex, level of education.

Time frame
5 minutes

Secondary outcomes

1

Assessing Influences on Brain Function: NeuroCatch® to Lifestyle and Health Factors

Measurements include: current medications, mood, total sleep hours, caffeine and alcohol intake, nicotine and psychoactive substance use, as well as any medications taken within 24 hours before the scan, noting whether each is more, less, or equal to the participant's typical amount.

Time frame
5 minutes

Other outcomes

1

Safety assessments

Safety assessments will me assessed by subjective report of incidence and severity of adverse events.

Time frame
30 minutes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

HealthTech Connex Inc.

Lead sponsor

NeuroCatch Inc.

Collaborator

Source ClinicalTrials.gov
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