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Recruiting
View on ClinicalTrials.gov

Testing NeuroCatch® Platform 2 for healthy controls

Official title: NeuroCatch Reference Interval Database

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

Condition: Healthy ControlsSponsor: HealthTech Connex Inc.Target enrollment: 810
  • 1 group
  • One site, in Surrey
  • Recruiting
Centre for Neurology Studies, 13761 96 Ave, Unit 1004, Surrey, British Columbia

Interventions

  • Medical 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.

Canadian Sites (1)

1 of 1 recruiting

  • Centre for Neurology Studies, 13761 96 Ave, Unit 1004

    Surrey, British Columbia

    Recruiting

Eligibility Criteria

See who this study is looking for37 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +Allergy to EEG gel
  • +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.
  • +Any sex, at least 6 years of age or older
  • +Able to understand the informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →/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
  • +EXCLUSION CRITERIAExclusion criteriaThe things that would prevent someone from taking part.Read more →
  • +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 InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, 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.)
  • +Unhealthy scalp (e.g., apparent open wounds and/or bruised or weakened skin)
  • +Undergoing chemotherapy or any form of intensive long-term therapy that, in the opinion of the Investigator, may impact brain function.

Exclusion

  • Allergy to EEG gel
  • 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 InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, 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.)
  • Unhealthy scalp (e.g., apparent open wounds and/or bruised or weakened skin)
  • Undergoing chemotherapy or any form of intensive long-term therapy that, in the opinion of the Investigator, may impact brain function.
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study does not fall into the standard research categories.

This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

Everyone in this study is in one group and receives NeuroCatch® Platform 2.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

There is only one group in this study, so there is no assignment to different treatments.

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists a minimum age of 6 years, with no upper limit given.

The study is open to people of any sex.

The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 810 people.

The study is currently expected to finish around August 2026.

The main measurement is taken over: 20 minutes.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Amplitude & Latency collection for NeuroCatch® Platform 2 — measured over 20 minutes.

Demographic indicators — measured over 5 minutes.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT06677424 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About NeuroCatch® Platform 2Device

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.

From the trial registry — its own words, unedited.

What a device is here: A physical instrument, implant, app or piece of equipment being studied.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: a minimum age of 6 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

There is only one group in this study, so there is no assignment to different treatments.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists a minimum age of 6 years, with no upper limit given.

It is open to people of any sex.

It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: 20 minutes.

The study as a whole is currently expected to finish around 2026-08.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 810 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists one location: Surrey, British Columbia, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About 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).

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.