NeuroCatch® Platform 2 for Brain Function

(RR Trial)

Overseen By Monica Vo

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: HealthTech Connex Inc.

Must not be taking: Antiepileptics, Antipsychotics, Stimulants, others

Disqualifiers: Neurological disorders, Chronic pain, Psychiatric disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

810 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different brains react to sounds and words using the NeuroCatch® Platform 2 device. The goal is to gather data comparing individual brain responses to create a reference database, aiding in understanding differences across sex and age. Participants undergo a single brain scan while listening to specific audio sequences. This trial suits individuals in good health, without a history of major neurological issues, who can remain seated and focused for 7 minutes. As an unphased trial, it offers participants the opportunity to contribute to groundbreaking research that could enhance understanding of brain function across diverse populations.

Will I have to stop taking my current medications?

If you are taking medications that affect brain function, like antiepileptic drugs or antipsychotics, you may not be eligible to participate in the trial.

What prior data suggests that the NeuroCatch® Platform 2 is safe for brain function studies?

Research has shown that the NeuroCatch® Platform 2 is easy to use and safe. Health Canada has approved it, indicating a strong safety record. The device measures brain activity with an EEG, recording electrical signals in the brain during a 6-minute session where participants hear sounds and words at safe volumes.

Its approval for other uses further supports its safety for individuals. No serious side effects have been reported, making it a promising tool for studying brain responses without significant risks.

Why are researchers excited about this trial?

Researchers are excited about the NeuroCatch® Platform 2 because it offers a novel way to assess brain function using EEG data collection combined with a unique audio stimulus. Unlike traditional methods that might require more invasive procedures or less precise data, this platform uses a safe, six-minute auditory sequence to generate specific brain responses. The software automatically processes raw EEG data into clear, actionable results and securely stores them in the cloud, making it easier and faster to monitor brain health. This approach could lead to quicker, more accurate assessments of neurological conditions, providing a significant advancement over current technologies.

What evidence suggests that the NeuroCatch® Platform 2 is effective for assessing brain function?

Research has shown that the NeuroCatch® Platform 2, used by participants in this trial, measures brain function by recording brain activity in response to sounds. This device employs electroencephalography (EEG) to observe brain reactions to specific sounds and words. Although approved for use in Canada, limited information exists on its effectiveness for specific conditions. The device is designed to quickly and objectively assess brain function by analyzing responses to these sounds, contributing to a database that helps understand how different brains react. ^{1 2 3 4 5}

Who Is on the Research Team?

Jan Venter, MD

Principal Investigator

Centre for Neurology Studies

Are You a Good Fit for This Trial?

This trial is for healthy individuals who want to help understand brain responses to sounds and words. Participants will contribute to a database that compares these brain responses across different sexes and ages. The study requires one visit for a brain scan using the NeuroCatch® Platform 2 device.

Inclusion Criteria

I can stay seated and focused for 7 minutes.

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

I am 6 years old or older.

Exclusion Criteria

Implanted pacemaker or other electrical stimulator(s)

English is not my first language.

Previous exposure to the NeuroCatch® Platform 2 audio sequences in the last 3 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

15-30 minutes

1 visit (virtual)

Scan

Participants undergo a brain scan with the NeuroCatch® Platform 2, including demographic data collection and EEG setup

15-30 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the scan

30 minutes

What Are the Treatments Tested in This Trial?

Interventions

• NeuroCatch® Platform 2

Trial Overview The NeuroCatch® Platform 2, an approved medical device in Canada, is being tested to collect data on how the human brain reacts to auditory stimuli. This information will be used to create a reference interval database reflecting normal variations of brain function.

How Is the Trial Designed?

Group I: NeuroCatch® Platform 2 Experimental Treatment 1 Intervention

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.

NeuroCatch® Platform 2 is already approved in Canada for the following indications:

Approved in Canada as NeuroCatch Platform 2 for:

• Cognitive brain function assessment
• Traumatic brain injury
• Dementia

Who Is Running the Clinical Trial?

HealthTech Connex Inc.

Lead Sponsor

Trials

6

Recruited

990+

NeuroCatch Inc.

Industry Sponsor

Trials

9

Recruited

1,200+

Published Research Related to This Trial

The Percept™ PC platform by Medtronic represents a significant advancement in deep brain stimulation (DBS) technology, featuring brain sensing capabilities that allow for real-time monitoring and optimization of therapeutic stimulation.

This device not only enhances patient experience with improved battery life and MRI compatibility but also aims to refine treatment by correlating symptoms with neurophysiological data, although further research is needed to fully establish its clinical benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Device profile of the percept PC deep brain stimulation system for the treatment of Parkinson's disease and related disorders. Jimenez-Shahed, J.[2021]

The study introduces an integrated system that can continuously monitor both electrical (neuropotential) and chemical (neurochemical) signals in awake, behaving subjects, which is crucial for understanding neural activity and related diseases like Parkinson's.

This system features advanced technology, including a highly sensitive neurochemical module and a low-noise electrophysiological channel, allowing for precise data acquisition and real-time monitoring, which could enhance brain-computer interface applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wireless micropower instrumentation for multimodal acquisition of electrical and chemical neural activity. Mollazadeh, M., Murari, K., Cauwenberghs, G., et al.[2013]

Recent advancements in microfabricated electrochemical and optical spectroscopy technologies have significantly improved the ability to continuously and accurately monitor brain neurochemicals, which is crucial for diagnosing and treating brain diseases.

The review highlights the need for standardized brain neurochemical sensing devices in clinical settings, addressing current gaps in technology and suggesting future directions for development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain neurochemical monitoring. Zhang, Y., Jiang, N., Yetisen, AK.[2021]

Microfluidic and organ-on-chip technologies can create more accurate in vitro models of the central nervous system (CNS), which are essential for studying CNS disorders that traditional models struggle to replicate.

A new modular platform allows researchers to customize microfluidic units for specific experimental needs, enhancing the study of neuronal function and potentially leading to better understanding and treatment of CNS diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A modular microfluidic platform to enable complex and customisable in vitro models for neuroscience. Megarity, D., Vroman, R., Kriek, M., et al.[2022]

Integrated circuit (IC)-based neural amplifiers are essential for acquiring weak neural signals in a miniaturized, lightweight, and low-power format, making them suitable for portable and implantable neural recording systems.

These advanced amplifiers are being utilized in various applications, including basic neuroscience research, neural prostheses like brain-machine interfaces, and treatments for neurological disorders such as epilepsy, showcasing their versatility and importance in modern neuroscience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implantable neurotechnologies: a review of integrated circuit neural amplifiers. Ng, KA., Greenwald, E., Xu, YP., et al.[2018]

Citations

1. neurocatch.com neurocatch.com/

NeuroCatch: Home The NeuroCatch® Platform solves the complex and challenging task of measuring cognitive brain function simply, quickly and objectively.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06677424

NCT06677424 | NeuroCatch Reference Interval Database The purpose of this study is to understand how the brain responds to sounds and words, and how this response varies between individuals.

3. withpower.com withpower.com/trial/phase-healthy-controls-7-2024-14494

NeuroCatch® Platform 2 for Brain Function (RR Trial) The purpose of this study is to understand how the brain responds to sounds and words, and how this response varies between individuals.

4. medium.com medium.com/neurotechx/your-brain-in-six-minutes-the-neurocatch-platform-for-brain-assessment-2a134271cbb

Your Brain in Six Minutes: The NeuroCatch Platform for ... NeuroCatch's solution is based on electroencephalography (EEG) technology, which records electrical activity of the brain noninvasively ( ...

5. worksafebc.com worksafebc.com/resources/health-care-providers/guides/ebpg-rapid-review-neurocatch-platform-and-cognitive-brain-function?lang=en&direct

NeuroCatch® Platform and Cognitive Brain Function NeuroCatch® is designed to measure the cognitive brain function of patients by measuring event-related brain potentials through ...