Development of a Reference Interval Database With the NeuroCatch™ Platform

Brain Health Clinical Trial

Official title:

Empirical Distributions of ERP Components Elicited by the NeuroCatch™ Platform: Development of a Reference Interval Database

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03835962
• Other study ID #: NCI_NCClin_002
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: March 2021
• Source: NeuroCatch Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years and older

Eligibility

Inclusion Criteria:

1. Any sex, at least 8 years of age or older

2. Able to understand the informed consent/assent form, study procedures and willing to participate in study

3. Able to remain seated and focused for 6 minutes

4. Normal hearing capabilities

Exclusion Criteria:

1. Clinically documented hearing issues (e.g. tinnitus, in-ear hearing problems or punctured ear drum)

2. Implanted pacemaker or implanted electrical stimulators

3. Metal or plastic implants in skull

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. Previous exposure to the NeuroCatch™ Platform audio sequences in the last 6 months

7. If female and of child-bearing potential: pregnant, suspected or planning to become pregnant or breast-feeding

8. History of seizures

9. Allergy to rubbing alcohol or EEG gel

10. Unhealthy scalp (apparent open wounds and/or bruised or weakened skin)

Related Conditions & MeSH terms

• Brain Health

Intervention

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.

Locations

Country	Name	City	State
Canada	HealthTech Connex Centre for Neurology Studies	Surrey	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
NeuroCatch Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response size of selected ERPs (N100, P300, N400) acquired using the NeuroCatch™ Platform	Response size will be measured as amplitude in microvolts.	1 day
Primary	Response timing of selected ERPs (N100, P300, N400) acquired using the NeuroCatch™ Platform	Response timing will be measured as latency in milliseconds.	1 day
Secondary	Collection and evaluation of adverse events and adverse device effects	Evaluation of safety and tolerability of the NeuroCatch™ Platform device	1 day
Secondary	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.	1 day