Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT06677424

NeuroCatch Reference Interval Database

Sponsor: HealthTech Connex Inc.

View on ClinicalTrials.gov

Summary

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).

Official title: Empirical Distributions of ERP Components Elicited by the NeuroCatch® Platform 2: Development of a Reference Interval Database

Key Details

Gender

All

Age Range

6 Years - Any

Study Type

INTERVENTIONAL

Enrollment

810

Start Date

2024-08-05

Completion Date

2026-08

Last Updated

2024-11-06

Healthy Volunteers

Yes

Conditions

Healthy Controls Brain Function

Interventions

DEVICE

NeuroCatch® Platform 2

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.

INCLUSION CRITERIA 1. Any sex, at least 6 years of age or older 2. 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. 3. Able to remain seated and focused for 7 minutes 4. In good health with no history of clinically relevant neurological illness or injury EXCLUSION CRITERIA 1. 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. 2. Implanted pacemaker or other electrical stimulator(s) 3. Metal or plastic implants in the skull, excluding dental/facial implants. 4. Not native-level in English 5. Previous exposure to the NeuroCatch® Platform 2 audio sequences in the last 3 months 6. History of clinically relevant neurological disorders or injury (e.g., epilepsy, Parkinson's disease, traumatic brain injury, etc.) 7. History of chronic pain or chronic headache disorders (e.g. migraine, tension headaches, fibromyalgia, etc.) 8. Currently diagnosed with any sleeping disorders (e.g. sleep apnea, hypersomnia, insomnia, parasomnia, etc.) 9. Diagnosed with any memory disorders. 10. History of clinically relevant major psychiatric disorders (e.g., schizophrenia, bipolar disorder, etc.) 11. History of alcohol or substance misuse that, in the opinion of the Investigator, may impact brain function 12. Use of medications that affect brain function (e.g., antiepileptic drugs, antipsychotics, stimulants, etc.) 13. Serious medical conditions affecting brain functions (e.g., stroke, brain tumor, neurodegenerative diseases, etc.) 14. Undergoing chemotherapy or any form of intensive long-term therapy that, in the opinion of the Investigator, may impact brain function. 15. Unhealthy scalp (e.g., apparent open wounds and/or bruised or weakened skin) 16. Allergy to EEG gel

Locations (1)

Centre for Neurology Studies, 13761 96 Ave, Unit 1004

Surrey, British Columbia, Canada