NeuroCatch Reference Interval Database

NCT06677424 | Recruiting

• 1 other identifier: NCI_NCClin_007
• Study Type: interventional
• Target: 810
• Locations: 1 country
• Sites: 1

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

Keywords

Brain Scan, NeuroCatch®

Outcome Measures

Primary Outcomes (2)

• 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.

  20 minutes

• Demographic indicators

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

  5 minutes

Secondary Outcomes (1)

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

  5 minutes

Other Outcomes (1)

• Safety assessments

  30 minutes

Study Arms (1)

NeuroCatch® Platform 2

OTHER

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.

Device: NeuroCatch® Platform 2

Interventions

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.

NeuroCatch® Platform 2

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Previous exposure to the NeuroCatch® Platform 2 audio sequences in the last 3 months
• History of clinically relevant neurological disorders or injury (e.g., epilepsy, Parkinson's disease, traumatic brain injury, etc.)
• History of chronic pain or chronic headache disorders (e.g. migraine, tension headaches, fibromyalgia, etc.)
• Currently diagnosed with any sleeping disorders (e.g. sleep apnea, hypersomnia, insomnia, parasomnia, etc.)
• Diagnosed with any memory disorders.
• History of clinically relevant major psychiatric disorders (e.g., schizophrenia, bipolar disorder, etc.)
• History of alcohol or substance misuse that, in the opinion of the Investigator, may impact brain function
• Use of medications that affect brain function (e.g., antiepileptic drugs, antipsychotics, stimulants, etc.)
• Serious medical conditions affecting brain functions (e.g., stroke, brain tumor, neurodegenerative diseases, etc.)
• Undergoing chemotherapy or any form of intensive long-term therapy that, in the opinion of the Investigator, may impact brain function.
• Unhealthy scalp (e.g., apparent open wounds and/or bruised or weakened skin)

Sponsors & Collaborators

• HealthTech Connex Inc.: lead
• NeuroCatch Inc.: collaborator

Study Sites (1)

Centre for Neurology Studies, 13761 96 Ave, Unit 1004

Surrey, British Columbia, V3V 0E8, Canada

RECRUITING

Related Links

• The study is live, if you are interested learning or want to participate to sign up via the URL hereto let us know you are interested.

Study Officials

• Jan Venter, MD

  Centre for Neurology Studies

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sonia Brodie

CONTACT

604-308-5900; cnsneurostudies@gmail.com

Monica Vo

CONTACT

778-735-1986; cnsneurostudies@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, non-randomized, between-subject design

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: November 6, 2024
• Study Start: August 5, 2024
• Primary Completion: February 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)