Clinical trial NCT04661592: NCP 2.0 Repeat Study
Official title: Assessing Repeatability of the NeuroCatch Platform 2.0 Stimulus Sequences
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Health
Lead sponsor: NeuroCatch Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-10
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Longitudinal
Primary purpose: OTHER

Brief summary: The NeuroCatch Platform™ version 2.0 (NCP2.0), 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 reliable and repeatable the ERP metrics elicited by the NCP platform are within participants over multiple sessions.

Detailed description: A new method for creating stimulus sequences was developed for NeuroCatch™ Platform 2.0. Rather than using a set of fixed, predetermined sequences to elicit ERPs this new method draws on a database of candidate word stimuli to generate a different, random stimulus sequence each time a scan is carried out. The goal of this is to reduce habituation to the stimulus sequences which is hypothesized to improve the repeatability of the component measurements. Characterizing how individuals respond to the stimulus sequences is an important step in the validation of the generation method itself. Understanding the degree of variability and prototypical values of each ERP component is crucial to the understanding of typical brain functioning. For this type of technology to be clinically viable in quantifying brain health, the investigators must first quantify the degree to which a healthy brain naturally fluctuates in it processing capability. This study is being carried out to assess how repeatable the ERPs elicited by the new method are while also considering the impact of intraindividual variability observed in previous investigations. Thus, by comparing the results of the scans over time, an assessment of the reliability of the new stimulus sequences can be made.

Eligibility criteria: Inclusion Criteria:

1. Any sex, at least 19 years of age or older
2. Able to understand the informed consent form, study procedures and willing to participate in study
3. Able to remain seated and focused for 7 minutes
4. In good health with no history of clinically relevant neurological illness or injury in the last 5 years

Exclusion Criteria:

1. Requires the use of hearing aids or a cochlear implant, diagnosed with tinnitus that is currently active, or has temporary damage to earing (e.g. punctured ear drum). Or unable to detect a 740Hz tone played at 85dB in both ears.
2. Implanted pacemaker or implanted electrical stimulators
3. Metal or plastic implants in the skull, excluding dental/facial implants
4. 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
5. Not proficient in English language
6. Diagnosed epilepsy or history of seizures
7. If female and of child-bearing potential: pregnant, suspected or planning to become pregnant or breast-feeding
8. Unhealthy scalp (apparent open wounds and/or bruised or weakened skin)

Primary outcomes:
measure: Change in amplitudes of the N100 ERP acquired using the NeuroCatch™ Platform over 2 weeks - repeatability
timeFrame: Baseline, +1 Week, +2 Weeks
measure: Change in amplitudes of the N100 ERP acquired using the NeuroCatch™ Platform over 2 weeks - variability
timeFrame: Baseline, +1 Week, +2 Weeks
measure: Change in Latency of the N100 ERP acquired using the NeuroCatch™ Platform over 2 weeks - repeatability
timeFrame: Baseline, +1 Week, +2 Weeks
measure: Change in Latency of the N100 ERP acquired using the NeuroCatch™ Platform over 2 weeks - variability
timeFrame: Baseline, +1 Week, +2 Weeks
measure: Change in amplitudes of the P300 ERP acquired using the NeuroCatch™ Platform over 2 weeks - repeatability
timeFrame: Baseline, +1 Week, +2 Weeks
measure: Change in amplitudes of the P300 ERP acquired using the NeuroCatch™ Platform over 2 weeks - variability
timeFrame: Baseline, +1 Week, +2 Weeks
measure: Change in Latency of the P300 ERP acquired using the NeuroCatch™ Platform over 2 weeks - repeatability
timeFrame: Baseline, +1 Week, +2 Weeks
measure: Change in Latency of the P300 ERP acquired using the NeuroCatch™ Platform over 2 weeks - variability
timeFrame: Baseline, +1 Week, +2 Weeks
measure: Change in amplitudes of the N400 ERP acquired using the NeuroCatch™ Platform over 2 weeks - repeatability
timeFrame: Baseline, +1 Week, +2 Weeks
measure: Change in amplitudes of the N400 ERP acquired using the NeuroCatch™ Platform over 2 weeks - variability
timeFrame: Baseline, +1 Week, +2 Weeks
measure: Change in Latency of the N400 ERP acquired using the NeuroCatch™ Platform over 2 weeks - repeatability
timeFrame: Baseline, +1 Week, +2 Weeks
measure: Change in Latency of the N400 ERP acquired using the NeuroCatch™ Platform over 2 weeks - variability
timeFrame: Baseline, +1 Week, +2 Weeks
Secondary outcomes:
measure: Collection and evaluation of adverse events and adverse device effects
timeFrame: At time of event
measure: Change in hours of sleep of the day of scan
timeFrame: Baseline, +1 Week, +2 Weeks
measure: Change in perceived mood on the day of scan
timeFrame: Baseline, +1 Week, +2 Weeks
Other outcomes:
Locations:
city: Surrey
country: Canada
facility: HealthTech Connex Inc. Centre for Neurology Studies
state: British Columbia
Study officials:
affiliation: HealthTech Connex Inc.
name: Jan Venter, MD
role: PRINCIPAL_INVESTIGATOR
References: