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Trial record 1 of 1 for:    NCT03835962
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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
Sponsor:
Information provided by (Responsible Party):
NeuroCatch Inc.

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Brain Health Device: NeuroCatch™ Platform Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Collection and evaluation of adverse events and adverse device effects [ Time Frame: 1 day ]
    Evaluation of safety and tolerability of the NeuroCatch™ Platform device

  2. 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.


Eligibility Criteria
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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
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Canada, British Columbia
HealthTech Connex Centre for Neurology Studies
Surrey, British Columbia, Canada, V3V 0C6
Sponsors and Collaborators
NeuroCatch Inc.
More Information
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Responsible Party: NeuroCatch Inc.
ClinicalTrials.gov Identifier: NCT03835962    
Other Study ID Numbers: NCI_NCClin_002
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No