Development of a Reference Interval Database With the NeuroCatch™ Platform
NCT ID: NCT03835962
Last Updated: 2021-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
135 participants
INTERVENTIONAL
2019-03-01
2020-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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)
8 Years
ALL
Yes
Sponsors
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NeuroCatch Inc.
INDUSTRY
Responsible Party
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Locations
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HealthTech Connex Centre for Neurology Studies
Surrey, British Columbia, Canada
Countries
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Other Identifiers
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NCI_NCClin_002
Identifier Type: -
Identifier Source: org_study_id
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