Brain HealthNCT03835962
Development of a Reference Interval Database With the NeuroCatch™ Platform
A study testing NeuroCatch™ Platform in people with Brain Health, run by NeuroCatch Inc. at 1 site in Canada.
Trial summary
The NeuroCatch Platform™, an investigational 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… Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy 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
- 135 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2019to 31 Jan 2020
- 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 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Any sex, at least 8 years of age or older
- Able to understand the informed consent/assent form, study procedures and willing to participate in study
- Able to remain seated and focused for 6 minutes
- Normal hearing capabilities
Who cannot join
- Clinically documented hearing issues (e.g. tinnitus, in-ear hearing problems or punctured ear drum)
- Implanted pacemaker or implanted electrical stimulators
- Metal or plastic implants in skull
- Exposed to an investigational drug or device 30 days prior to start in this study, or concurrent or planned use of investigational drug or device while enrolled in this study
- Not proficient in English language
- Previous exposure to the NeuroCatch™ Platform audio sequences in the last 6 months
Show all 10Show fewer
- 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
- Unhealthy scalp (apparent open wounds and/or bruised or weakened skin)
Trial locations and contacts
1 site in 1 country.
Canada1 site
HealthTech Connex Centre for Neurology Studies
Surrey, British Columbia, V3V 0C6
About this study
Official title: Empirical Distributions of ERP Components Elicited by the NeuroCatch™ Platform: Development of a Reference Interval Database
The NeuroCatch Platform™, an investigational 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 purpose of the study is to understand how the brain responds to sounds and words, and how this response varies between individuals of different age groups. Interindividual variation reflects the many different factors which cause results to vary from one individual to another within a population. The current clinical study aims to establish a reference interval database of ERPs. These reference intervals will characterize the expected range of interindividual variability between groups. Reference interval databases provide a tool for comparing the results from one individual with those from other members of the same age group.
- 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™ PlatformDevice
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 one experimental session. During the session, participants will listen one auditory stimulus sequence 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.
Response size of selected ERPs (N100, P300, N400) acquired using the NeuroCatch™ Platform
Response size will be measured as amplitude in microvolts.
Measured: 1 day
Response timing of selected ERPs (N100, P300, N400) acquired using the NeuroCatch™ Platform
Response timing will be measured as latency in milliseconds.
Measured: 1 day
Secondary outcomes (2)
Collection and evaluation of adverse events and adverse device effects
Evaluation of safety and tolerability of the NeuroCatch™ Platform device
Measured: 1 day
Demographic indicators (date of birth, sex, level of education, recent sleep, average sleep, fatigue level, recent exercise, recent diet, handedness, first language, medical history, neurological status, and profession)
Secondary statistical analyses will explore relationships between demographic indicators, medical history, neurological status and ERP measures across the sample and within groups.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start1 Mar 2019
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroCatch Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835962
- Sponsor's protocol ID
- NCI_NCClin_002
- Status last verified
- Mar 2021
- First submitted
- 7 Feb 2019
- 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
- Empirical Distributions of ERP Components Elicited by the NeuroCatch™ Platform: Development of a Reference Interval Database
- ClinicalTrials.gov ID
- NCT03835962
- Acronym / sponsor ID
- NCI_NCClin_002
- Conditions
- Brain Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- NeuroCatch Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 11 Feb 2019 (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 NeuroCatch Platform™, an investigational 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 purpose of the study is to understand how the brain responds to sounds and words, and how this response varies between individuals of different age groups. Interindividual variation reflects the many different factors which cause results to vary from one individual to another within a population. The current clinical study aims to establish a reference interval database of ERPs. These reference intervals will characterize the expected range of interindividual variability between groups. Reference interval databases provide a tool for comparing the results from one individual with those from other members of the same age group.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Device: NeuroCatch™ PlatformAll participants will be asked to attend one experimental session. During the session, participants will listen one auditory stimulus sequence including sounds and words while EEG activity is recorded using the NeuroCatch Platform™ device. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Any sex, at least 8 years of age or older
- Able to understand the informed consent/assent form, study procedures and willing to participate in study
- Able to remain seated and focused for 6 minutes
- Normal hearing capabilities
Key exclusion criteria (10 listed)
- Clinically documented hearing issues (e.g. tinnitus, in-ear hearing problems or punctured ear drum)
- Implanted pacemaker or implanted electrical stimulators
- Metal or plastic implants in skull
- Exposed to an investigational drug or device 30 days prior to start in this study, or concurrent or planned use of investigational drug or device while enrolled in this study
- Not proficient in English language
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™ PlatformNeuroCatch 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
Response size of selected ERPs (N100, P300, N400) acquired using the NeuroCatch™ Platform
Time frame: 1 day
Response size will be measured as amplitude in microvolts.
Response timing of selected ERPs (N100, P300, N400) acquired using the NeuroCatch™ Platform
Time frame: 1 day
Response timing will be measured as latency in milliseconds.
2 secondary outcomes
Collection and evaluation of adverse events and adverse device effects
Time frame: 1 day
Demographic indicators (date of birth, sex, level of education, recent sleep, average sleep, fatigue level, recent exercise, recent diet, handedness, first language, medical history, neurological status, and profession)
Time frame: 1 day
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
Related trials for Brain Health
Not yet recruiting
Creatine and Perioperative Brain Health
Neurocognitive Disorders, Postoperative Delirium
Recruiting
Combating Alzheimer's Through Sleep and Exercise
Dementia, Mild Cognitive Impairment (MCI)
Recruiting
The Impact of Overnight Active Temperature Regulation on the Gut Microbiome, Inflammation, and Circadian Rhythm.
Poor Sleep Quality, Gut Microbiome
Recruiting
Ambient Air and Noise Effect on Cardiovascular Health Risk and Lifestyle Intervention to Attenuate It (METSGREEN)
Cardiovascular Diseases (CVD), Metabolic Syndrome
Recruiting
MediPD: An Online Mediterranean Diet Program for People Living With Parkinson's Disease
Parkinson Disease, Idiopathic
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.
The record lists no contact. Use the official record to reach the sponsor.
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 10 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?
Response size of selected ERPs (N100, P300, N400) acquired using the NeuroCatch™ Platform (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.