NeuroCatch Reference Interval Database

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

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

Treatments tested in this trial

  • NeuroCatch® Platform 2

Treatment groups

810 Participants
are divided into 1 treatment group

Sponsors and collaborators

HealthTech Connex Inc.

Lead sponsor

NeuroCatch Inc.

Collaborator