Recruiting

Observational Study

Sponsor:

HealthTech Connex Inc.

Code:

NCT06677424

Conditions

Healthy Controls

Brain Function

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Accepted

Interventions

NeuroCatch® Platform 2

Study Details

Brief 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).

Conditions

Healthy Controls

Brain Function

Study ID

NCT06677424

Start date

Aug 5, 2024

Status verified date

Nov, 2024

Completion date

Aug, 2026

Anticipated

Primary completion date

Feb, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

810 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: NeuroCatch® Platform 2

NeuroCatch® Platform 2 Software enables EEG data collection by recording the data during an audio stimulus presentation (i.e., the NeuroCatch® Scan). The Software plays a 6-min proprietary audio sequence stimulus. The NeuroCatch® software generates unique, randomized audio sequences specifically designed to elicit specific brain responses. Once a NeuroCatch® Scan is complete, the software automatically processes the raw EEG data to generate 6 ERP results and saves the results, the data, and details about the scan to the secure NeuroCatch® server in the cloud.

While EEG is only collected during the scan, the participant is exposed to the device from the time the cap is placed on the head until it is taken off.

During the scan, the participant will listen to an auditory stimulus sequence consisting of tones and words. This has been designed and limited to safe audio levels.

Interventions

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.

Primary outcome measure

  • Amplitude & Latency collection for NeuroCatch® Platform 2 [ Time Frame: 20 minutes ]
  • Demographic indicators [ Time Frame: 5 minutes ]

Central Contacts and Locations

Locations

Centre for Neurology Studies, 13761 96 Ave, Unit 1004

Recruiting

Surrey, British Columbia, Canada, V3V 0E8

Contacts

More Information

Sponsor

HealthTech Connex Inc.

Last update posted

Nov 6, 2024

Last verified

Nov, 2024

Keywords

  • Brain Scan, NeuroCatch®

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by HealthTech Connex Inc. on 2024-11-06.