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Trial record 1 of 1 for:    NCT03421405
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Assessing Repeatability of NeuroCatch Platform™ Measurements: An Initial Assessment

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: NCT03421405
Recruitment Status : Completed
First Posted : February 5, 2018
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
NeuroCatch Inc.

Tracking Information
First Submitted Date  ICMJE January 23, 2018
First Posted Date  ICMJE February 5, 2018
Last Update Posted Date May 11, 2018
Actual Study Start Date  ICMJE January 2, 2018
Actual Primary Completion Date February 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2018)
  • Variability of response size of selected ERPs (N100, P300, N400) acquired using the NeuroCatch Platform™ during the baseline visit [ Time Frame: 1 day ]
    Response size will be measured as amplitude in microvolts.
  • Variability of response timing of selected ERPs (N100, P300, N400) acquired using the NeuroCatch Platform™ during the baseline visit [ 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: January 29, 2018)
  • Qualitative comparison of ERP graphs generated by different auditory stimulus sequences during the NeuroCatch Platform™ assessment [ Time Frame: 1 day ]
    ERP graphs will be overlaid. Trained technician will assess if peaks and valleys occur at expected time points for different sequences.
  • Collection and evaluation of adverse events and adverse device effects [ Time Frame: 4 weeks ]
    Evaluation of safety and tolerability of the NeuroCatch Platform™ device
  • Slope of change over time in response size to quantify the natural variability in selected ERPs (N100, P300, N400) acquired using NeuroCatch Platform™ [ Time Frame: 4 weeks ]
    Response size will be measured as amplitude in microvolts. Means will be calculated and compared over time.
  • Slope of change over time in response timing to quantify the natural variability in selected ERPs (N100, P300, N400) acquired using NeuroCatch Platform™ [ Time Frame: 4 weeks ]
    Response timing will be measured as latency in milliseconds. Means will be calculated and compared over time.
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 Assessing Repeatability of NeuroCatch Platform™ Measurements: An Initial Assessment
Official Title  ICMJE Assessing Repeatability of NeuroCatch Platform™ Measurements: An Initial Assessment
Brief Summary

EEG signals have been collected and studied since the early 1990's as a way of assessing brain function at a gross level. As early as the 1930's a derivative of the raw EEG signal - event-related potentials (ERPs) - have been computed. These scalp-recorded ERPs are the brains response to a stimulus of interest (e.g. a flashing checkerboard or an angry face). The timing and topographical location of ERP components lends insight into the timing and complexity of various cognitive processes. At NeuroCatch Inc., research is primarily focused on three ERP components: the N100, P300 and N400.

To elicit the ERP components of interest in this study (N100, P300, N400), proprietary auditory stimulus sequences will be administered using the investigational device, the NeuroCatch Platform™. Each sequence consists of pure tones and word pairs to elicit the various components associated with different attention abilities (sensory processing, target detection & semantic processing). A secondary objective of the study will be to validate the auditory stimulus sequences tested.

Understanding the degree to which these neurophysiological components fluctuate over time is crucial to our understanding of typical brain functioning. Research and medicine is moving away from behavioural responses to assess brain health (e.g. verbal responses, reaction time, etc.) and are moving toward more neuroimaging focused measures, such as CT, and MRI scans. The strength of utilizing EEG technology is two-fold: i) it is portable and ii) has high temporal resolution. Looking forward, EEG-based brain assessment technology could be implemented field-side, at the site of an accident for a quick assessment of brain and cognitive functioning, or within a clinicians' office to evaluate treatment efficacy. However, for this type of technology to be useful in quantifying brain health, we must first quantify the degree to which a healthy brain naturally fluctuates in it processing capability. For example, should technology such as the NeuroCatch Platform™ be used as a monitoring tool, we must have an idea of what normal variation is.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
All participants will be asked to attend 4 separate experimental sessions over the course of approximately 4 weeks (i.e. one session/week). During each session, participants will listen to three different auditory stimulus sequences including sounds and words while EEG activity is recorded. There will be 5-minute break between each audio sequence. Each experimental session will take approximately 30-45 minutes to complete.
Masking: None (Open Label)
Primary Purpose: Device Feasibility
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 4 separate experimental sessions over the course of approximately 4 weeks (i.e. one session/week). During each session, participants will listen to three different auditory stimulus sequences 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: January 29, 2018)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 1, 2018
Actual Primary Completion Date February 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female, 19-65 years old inclusively
  2. Normal hearing capabilities
  3. Able to understand the informed consent form, study procedures and willing to participate in study
  4. Able to keep eyes still for min 6 minutes

Exclusion Criteria:

  1. Clinically documented hearing issues (e.g. tinnitus, in-ear hearing problems, punctured ear drum, etc.)
  2. Implanted pacemaker
  3. Metal or plastic implants in skull
  4. In-ear hearing aid or chocclear implant, hearing device
  5. Chronic neurological disorder (e.g. Stroke, MS, etc.)
  6. Recent (within last 6 months) acquired brain injury
  7. History of brain cancer
  8. History of dementia
  9. Exposed to investigational drug or device 30 days prior to start in this study, or concurrent use of investigational drug or device while enrolled in this study
  10. Planning to use investigational drugs or devices while enrolled in this study
  11. Not fluent in English language
  12. Unable to provide informed consent
  13. Previous participation in studies using the NeuroCatch Platform™
  14. If female and of child-bearing potential: pregnant, suspected or planning to become pregnant or breast-feeding
  15. History of seizures
  16. Allergy to rubbing alcohol or EEG gel
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 65 Years   (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 NCT03421405
Other Study ID Numbers  ICMJE NCI_NCClin_001
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
Principal Investigator: Jan Venter, MBChB MFamMed CCFP IFMCP HealthTech Connex Inc. Centre for Neurology Studies
PRS Account NeuroCatch Inc.
Verification Date May 2018

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