Brain HealthNCT03421405
Assessing Repeatability of NeuroCatch Platform™ Measurements: An Initial Assessment
A study testing NeuroCatch Platform™ in people with Brain Health, run by NeuroCatch Inc. at 1 site in Canada.
Trial summary
EEG signals have been collected and studied since the early 1990's as a way of assessing brain function at a gross level. As early as the 1930's a derivative of the raw EEG signal - event-related potentials (ERPs) - have been computed. These scalp-recorded ERPs are the brains response to a stimulus of interest (e.g. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Health
- What is being tested?
- NeuroCatch Platform™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 2 Jan 2018to 1 Feb 2018
- 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, 19-65 years old inclusively
- Normal hearing capabilities
- Able to understand the informed consent form, study procedures and willing to participate in study
- Able to keep eyes still for min 6 minutes
Who cannot join
- Clinically documented hearing issues (e.g. tinnitus, in-ear hearing problems, punctured ear drum, etc.)
- Implanted pacemaker
- Metal or plastic implants in skull
- In-ear hearing aid or chocclear implant, hearing device
- Chronic neurological disorder (e.g. Stroke, MS, etc.)
- Recent (within last 6 months) acquired brain injury
Show all 16Show fewer
- History of brain cancer
- History of dementia
- Exposed to investigational drug or device 30 days prior to start in this study, or concurrent use of investigational drug or device while enrolled in this study
- Planning to use investigational drugs or devices while enrolled in this study
- Not fluent in English language
- Unable to provide informed consent
- Previous participation in studies using the NeuroCatch Platform™
- If female and of child-bearing potential: pregnant, suspected or planning to become pregnant or breast-feeding
- History of seizures
- Allergy to rubbing alcohol or EEG gel
Trial locations and contacts
1 site in 1 country.
Canada1 site
HealthTech Connex Inc. Centre for Neurology Studies
Vancouver, British Columbia, V3V 0C6
About this study
EEG signals have been collected and studied since the early 1990's as a way of assessing brain function at a gross level. As early as the 1930's a derivative of the raw EEG signal - event-related potentials (ERPs) - have been computed. These scalp-recorded ERPs are the brains response to a stimulus of interest (e.g. a flashing checkerboard or an angry face). The timing and topographical location of ERP components lends insight into the timing and complexity of various cognitive processes. At NeuroCatch Inc., research is primarily focused on three ERP components: the N100, P300 and N400.
To elicit the ERP components of interest in this study (N100, P300, N400), proprietary auditory stimulus sequences will be administered using the investigational device, the NeuroCatch Platform™. Each sequence consists of pure tones and word pairs to elicit the various components associated with different attention abilities (sensory processing, target detection \& semantic processing). A secondary objective of the study will be to validate the auditory stimulus sequences tested.
Understanding the degree to which these neurophysiological components fluctuate over time is crucial to our understanding of typical brain functioning. Research and medicine is moving away from behavioural responses to assess brain health (e.g. verbal responses, reaction time, etc.) and are moving toward more neuroimaging focused measures, such as CT, and MRI scans. The strength of utilizing EEG technology is two-fold: i) it is portable and ii) has high temporal resolution. Looking forward, EEG-based brain assessment technology could be implemented field-side, at the site of an accident for a quick assessment of brain and cognitive functioning, or within a clinicians' office to evaluate treatment efficacy. However, for this type of technology to be useful in quantifying brain health, we must first quantify the degree to which a healthy brain naturally fluctuates in it processing capability. For example, should technology such as the NeuroCatch Platform™ be used as a monitoring tool, we must have an idea of what normal variation is.
- Conditions
- Brain Health
- Being tested
- NeuroCatch Platform™
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroCatch Platform™Device
NeuroCatch Platform™ 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) information.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | All participants will be asked to attend 4 separate experimental sessions over the course of approximately 4 weeks (i.e. one session/week). During each session, participants will listen to three different auditory stimulus sequences including sounds and words while EEG activity is recorded using the NeuroCatch Platform™ device. Receives: Device: NeuroCatch Platform™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variability of response size of selected ERPs (N100, P300, N400) acquired using the NeuroCatch Platform™ during the baseline visit
Response size will be measured as amplitude in microvolts.
Measured: 1 day
Variability of response timing of selected ERPs (N100, P300, N400) acquired using the NeuroCatch Platform™ during the baseline visit
Response timing will be measured as latency in milliseconds.
Measured: 1 day
Secondary outcomes (4)
Qualitative comparison of ERP graphs generated by different auditory stimulus sequences during the NeuroCatch Platform™ assessment
ERP graphs will be overlaid. Trained technician will assess if peaks and valleys occur at expected time points for different sequences.
Measured: 1 day
Collection and evaluation of adverse events and adverse device effects
Evaluation of safety and tolerability of the NeuroCatch Platform™ device
Measured: 4 weeks
Slope of change over time in response size to quantify the natural variability in selected ERPs (N100, P300, N400) acquired using NeuroCatch Platform™
Response size will be measured as amplitude in microvolts. Means will be calculated and compared over time.
Measured: 4 weeks
Slope of change over time in response timing to quantify the natural variability in selected ERPs (N100, P300, N400) acquired using NeuroCatch Platform™
Response timing will be measured as latency in milliseconds. Means will be calculated and compared over time.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start2 Jan 2018
- Primary completion1 Feb 2018
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain HealthStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will be asked to attend 4 separate experimental sessions over the course of approximately 4 weeks (i.e. one session/week). During each session, participants will listen to three different auditory stimulus sequences including sounds and words while EEG activity is recorded. There will be 5-minute break between each audio sequence. Each experimental session will take approximately 30-45 minutes to complete.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroCatch Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan Venter, MBChB MFamMed CCFP IFMCP, Principal investigator, HealthTech Connex Inc. Centre for Neurology Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421405
- Sponsor's protocol ID
- NCI_NCClin_001
- Status last verified
- Mar 2021
- First submitted
- 23 Jan 2018
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Repeatability of NeuroCatch Platform™ Measurements: An Initial Assessment
- ClinicalTrials.gov ID
- NCT03421405
- Acronym / sponsor ID
- NCI_NCClin_001
- Conditions
- Brain Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- NeuroCatch Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 5 Feb 2018 (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.
EEG signals have been collected and studied since the early 1990's as a way of assessing brain function at a gross level. As early as the 1930's a derivative of the raw EEG signal - event-related potentials (ERPs) - have been computed. These scalp-recorded ERPs are the brains response to a stimulus of interest (e.g. a flashing checkerboard or an angry face). The timing and topographical location of ERP components lends insight into the timing and complexity of various cognitive processes. At NeuroCatch Inc., research is primarily focused on three ERP components: the N100, P300 and N400.
To elicit the ERP components of interest in this study (N100, P300, N400), proprietary auditory stimulus sequences will be administered using the investigational device, the NeuroCatch Platform™. Each sequence consists of pure tones and word pairs to elicit the various components associated with different attention abilities (sensory processing, target detection \& semantic processing). A secondary objective of the study will be to validate the auditory stimulus sequences tested.
Understanding the degree to which these neurophysiological components fluctuate over time is crucial to our understanding of typical brain functioning. Research and medicine is moving away from behavioural responses to assess brain health (e.g. verbal responses, reaction time, etc.) and are moving toward more neuroimaging focused measures, such as CT, and MRI scans. The strength of utilizing EEG technology is two-fold: i) it is portable and ii) has high temporal resolution. Looking forward, EEG-based brain assessment technology could be implemented field-side, at the site of an accident for a quick assessment of brain and cognitive functioning, or within a clinicians' office to evaluate treatment efficacy. However, for this type of technology to be useful in quantifying brain health, we must first quantify the degree to which a healthy brain naturally fluctuates in it processing capability. For example, should technology such as the NeuroCatch Platform™ be used as a monitoring tool, we must have an idea of what normal variation is.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will be asked to attend 4 separate experimental sessions over the course of approximately 4 weeks (i.e. one session/week). During each session, participants will listen to three different auditory stimulus sequences including sounds and words while EEG activity is recorded. There will be 5-minute break between each audio sequence. Each experimental session will take approximately 30-45 minutes to complete.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Device: NeuroCatch Platform™All participants will be asked to attend 4 separate experimental sessions over the course of approximately 4 weeks (i.e. one session/week). During each session, participants will listen to three different auditory stimulus sequences including sounds and words while EEG activity is recorded using the NeuroCatch Platform™ device. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, 19-65 years old inclusively
- Normal hearing capabilities
- Able to understand the informed consent form, study procedures and willing to participate in study
- Able to keep eyes still for min 6 minutes
Key exclusion criteria (16 listed)
- Clinically documented hearing issues (e.g. tinnitus, in-ear hearing problems, punctured ear drum, etc.)
- Implanted pacemaker
- Metal or plastic implants in skull
- In-ear hearing aid or chocclear implant, hearing device
- Chronic neurological disorder (e.g. Stroke, MS, etc.)
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™NeuroCatch Platform™ 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) information. | Device | Intervention Arm |
Primary outcome
Variability of response size of selected ERPs (N100, P300, N400) acquired using the NeuroCatch Platform™ during the baseline visit
Time frame: 1 day
Response size will be measured as amplitude in microvolts.
Variability of response timing of selected ERPs (N100, P300, N400) acquired using the NeuroCatch Platform™ during the baseline visit
Time frame: 1 day
Response timing will be measured as latency in milliseconds.
4 secondary outcomes
Qualitative comparison of ERP graphs generated by different auditory stimulus sequences during the NeuroCatch Platform™ assessment
Time frame: 1 day
Collection and evaluation of adverse events and adverse device effects
Time frame: 4 weeks
Slope of change over time in response size to quantify the natural variability in selected ERPs (N100, P300, N400) acquired using NeuroCatch Platform™
Time frame: 4 weeks
Slope of change over time in response timing to quantify the natural variability in selected ERPs (N100, P300, N400) acquired using NeuroCatch Platform™
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Individual participant dataSharing planned: Undecided
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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, MBChB MFamMed CCFP IFMCP principal investigator
HealthTech Connex Inc. 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™ in people with Brain Health, run by NeuroCatch 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: finished, as of the sponsor's last update on 18 Mar 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Variability of response size of selected ERPs (N100, P300, N400) acquired using the NeuroCatch Platform™ during the baseline visit (time frame: 1 day). 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 18 Mar 2021.