Healthy ControlsRRNCT06677424
NeuroCatch Reference Interval Database
A study testing NeuroCatch® Platform 2 in people with Healthy Controls and Brain Function, run by HealthTech Connex Inc. at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Controls, Brain Function
- What is being tested?
- NeuroCatch® Platform 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteCanada
- Study dates
- 5 Aug 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
Show all 16Show fewer
- 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)
- Allergy to EEG gel
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for Neurology Studies, 13761 96 Ave, Unit 1004
Surrey, British Columbia, V3V 0E8
About this study
Official title: Empirical Distributions of ERP Components Elicited by the NeuroCatch® Platform 2: Development of a 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. 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).
Read the detailed description
Study specific Procedures: Includes a screen for eligibility and a scan visit. The total time 30 minutes to 1 hour for the whole study. The procedures can be completed on the same day or split between two days.
Screening visit (15- 30min, virtual visit): Prior to any procedures being conducted, Informed Consent Form will be reviewed in detail, an opportunity will be given to decide to participate in the study or not and if all the study requirements are met as well as all the questions have been answered, consent form is signed. Participant study eligibility is reviewed including medical history, and brain scan requirements. If participant is eligible, scan visit will be completed. If participant is not eligible no further study procedures will be completed.
Scan visit (15-30 min at the clinic): During the scan visit demographic information ( date of birth, sex, level of education, recent sleep, self-described mood, caffeine intake, alcohol consumption, nicotine usage, psychoactive usage, handedness, first language, profession and current medications) is collected, brain scan safety questionnaire is completed and a brain scan with NeuroCatch® Platform 2 will be completed.
NeuroCatch scan procedure: A cap with the EEG sensors is placed on your scalp and will be adjusted to get good recordings of brain activity. An alcohol pad is used to clean the skin of your forehead, and a plastic syringe tip or wooden dowel to move your hair out of the way to place the EEG sensors/electrodes. A small amount of a conductive gel is applied under each electrode. This takes between 5-20 minutes. Once its all set up, you will be asked to listen to an auditory sequence that is 6 minutes long. During this period, you are asked to sit still and listen to the sounds and the words.
Any information about you obtained from or for this research study will be kept as confidential as possible, All participants will be assigned a participant ID and data will identified using the ID.
- Conditions
- Healthy Controls, Brain Function
- Being tested
- NeuroCatch® Platform 2
- Keywords
- Brain Scan, NeuroCatch®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: NeuroCatch® Platform 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 minutes
Demographic indicators
Demographic indicators to be collected such as year of birth, sex, level of education.
Measured: 5 minutes
Secondary outcomes (1)
Assessing Influences on Brain Function: NeuroCatch® to Lifestyle and Health Factors
Measurements include: current medications, mood, total sleep hours, caffeine and alcohol intake, nicotine and psychoactive substance use, as well as any medications taken within 24 hours before the scan, noting whether each is more, less, or equal to the participant's typical amount.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start5 Aug 2024
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Why it stopped: The sponsor has concluded study activities at this site
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ControlsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label, non-randomized, between-subject design
- Masking
- None (open label)
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthTech Connex Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NeuroCatch Inc.
- Responsible party
- Sponsor
- Investigators
- Jan Venter, MD, Principal investigator, Centre for Neurology Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677424
- Sponsor's protocol ID
- NCI_NCClin_007
- Acronym
- RR
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2024
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empirical Distributions of ERP Components Elicited by the NeuroCatch® Platform 2: Development of a Reference Interval Database
- ClinicalTrials.gov ID
- NCT06677424
- Acronym / sponsor ID
- RR / NCI_NCClin_007
- Conditions
- Healthy Controls, Brain Function
- Keywords
- Brain Scan, NeuroCatch®
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The sponsor has concluded study activities at this site
- Enrolment
- 224 participants (actual)
- Lead sponsor
- HealthTech Connex Inc.Industry (pharma, biotech, devices)
- Collaborators
- NeuroCatch Inc.
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 6 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Study specific Procedures: Includes a screen for eligibility and a scan visit. The total time 30 minutes to 1 hour for the whole study. The procedures can be completed on the same day or split between two days.
Screening visit (15- 30min, virtual visit): Prior to any procedures being conducted, Informed Consent Form will be reviewed in detail, an opportunity will be given to decide to participate in the study or not and if all the study requirements are met as well as all the questions have been answered, consent form is signed. Participant study eligibility is reviewed including medical history, and brain scan requirements. If participant is eligible, scan visit will be completed. If participant is not eligible no further study procedures will be completed.
Scan visit (15-30 min at the clinic): During the scan visit demographic information ( date of birth, sex, level of education, recent sleep, self-described mood, caffeine intake, alcohol consumption, nicotine usage, psychoactive usage, handedness, first language, profession and current medications) is collected, brain scan safety questionnaire is completed and a brain scan with NeuroCatch® Platform 2 will be completed.
NeuroCatch scan procedure: A cap with the EEG sensors is placed on your scalp and will be adjusted to get good recordings of brain activity. An alcohol pad is used to clean the skin of your forehead, and a plastic syringe tip or wooden dowel to move your hair out of the way to place the EEG sensors/electrodes. A small amount of a conductive gel is applied under each electrode. This takes between 5-20 minutes. Once its all set up, you will be asked to listen to an auditory sequence that is 6 minutes long. During this period, you are asked to sit still and listen to the sounds and the words.
Any information about you obtained from or for this research study will be kept as confidential as possible, All participants will be assigned a participant ID and data will identified using the ID.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label, non-randomized, between-subject design
| Arm | Type | Receives |
|---|---|---|
| NeuroCatch® Platform 2 | Other | Device: NeuroCatch® Platform 2NeuroCatch® 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. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuroCatch® Platform 2The 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. | Device | NeuroCatch® Platform 2 |
Primary outcome
Amplitude & Latency collection for NeuroCatch® Platform 2
Time frame: 20 minutes
Response size (amplitude in microvolts) and response timing (latency in milliseconds) will be collected for the ERPs N100, P300 and N400.
Demographic indicators
Time frame: 5 minutes
Demographic indicators to be collected such as year of birth, sex, level of education.
1 secondary outcome
Assessing Influences on Brain Function: NeuroCatch® to Lifestyle and Health Factors
Time frame: 5 minutes
Results and safety
The study was stopped early (reason given: The sponsor has concluded study activities at this site). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Venter, MD principal investigator
Centre for Neurology Studies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuroCatch® Platform 2 in people with Healthy Controls and Brain Function, run by HealthTech Connex Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The sponsor has concluded study activities at this site). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amplitude & Latency collection for NeuroCatch® Platform 2 (time frame: 20 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.