Development of a Reference Interval Database With the NeuroCatch™ Platform
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|ClinicalTrials.gov Identifier: NCT03835962|
Recruitment Status : Completed
First Posted : February 11, 2019
Last Update Posted : March 18, 2021
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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.
|Condition or disease||Intervention/treatment||Phase|
|Brain Health||Device: NeuroCatch™ Platform||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||135 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Empirical Distributions of ERP Components Elicited by the NeuroCatch™ Platform: Development of a Reference Interval Database|
|Actual Study Start Date :||March 1, 2019|
|Actual Primary Completion Date :||January 31, 2020|
|Actual Study Completion Date :||January 31, 2020|
Experimental: Intervention Arm
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.
Device: 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.
- 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.
- Collection and evaluation of adverse events and adverse device effects [ Time Frame: 1 day ]Evaluation of safety and tolerability of the NeuroCatch™ Platform device
- 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 ]Secondary statistical analyses will explore relationships between demographic indicators, medical history, neurological status and ERP measures across the sample and within groups.
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|Ages Eligible for Study:||8 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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
- 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
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03835962
|Canada, British Columbia|
|HealthTech Connex Centre for Neurology Studies|
|Surrey, British Columbia, Canada, V3V 0C6|
|Responsible Party:||NeuroCatch Inc.|
|Other Study ID Numbers:||
|First Posted:||February 11, 2019 Key Record Dates|
|Last Update Posted:||March 18, 2021|
|Last Verified:||March 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|