Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03835962
Previous Study | Return to List | Next Study

Development of a Reference Interval Database With the NeuroCatch™ Platform

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03835962
Recruitment Status : Completed
First Posted : February 11, 2019
Last Update Posted : February 6, 2020
Sponsor:
Information provided by (Responsible Party):
NeuroCatch Inc.

Tracking Information
First Submitted Date  ICMJE February 7, 2019
First Posted Date  ICMJE February 11, 2019
Last Update Posted Date February 6, 2020
Actual Study Start Date  ICMJE March 1, 2019
Actual Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Development of a Reference Interval Database With the NeuroCatch™ Platform
Official Title  ICMJE Empirical Distributions of ERP Components Elicited by the NeuroCatch™ Platform: Development of a Reference Interval Database
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Brain Health
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Device: NeuroCatch™ Platform
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 5, 2020)
135
Original Estimated Enrollment  ICMJE
 (submitted: February 7, 2019)
200
Actual Study Completion Date  ICMJE January 31, 2020
Actual Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03835962
Other Study ID Numbers  ICMJE NCI_NCClin_002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party NeuroCatch Inc.
Study Sponsor  ICMJE NeuroCatch Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account NeuroCatch Inc.
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP