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

Trial Summary

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.

How does the NeuroCatch® Platform 2 treatment differ from other treatments for brain function?

The NeuroCatch® Platform 2 is unique because it is a non-invasive brain function assessment tool that provides real-time data on brain health, unlike traditional treatments that may focus on symptom management or invasive procedures. It offers a novel approach by using advanced technology to measure brain activity, which can help in understanding and monitoring brain function more precisely. ^{1 2 3 4 5}

What is the purpose of 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).

Research Team

Jan Venter, MD

Principal Investigator

Centre for Neurology Studies

Eligibility Criteria

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 am 6 years old 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

I can stay seated and focused for 7 minutes.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Brain neurochemical monitoring. [2021]

2. England pubmed.ncbi.nlm.nih.gov

A modular microfluidic platform to enable complex and customisable in vitro models for neuroscience. [2022]

3. England 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. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Implantable neurotechnologies: a review of integrated circuit neural amplifiers. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Wireless micropower instrumentation for multimodal acquisition of electrical and chemical neural activity. [2013]