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Trial record 1 of 1 for:    NCT03438851
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Assessing Brain Changes Throughout the ABI Wellness Program

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ClinicalTrials.gov Identifier: NCT03438851
Recruitment Status : Recruiting
First Posted : February 20, 2018
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
NeuroCatch Inc.

Tracking Information
First Submitted Date  ICMJE January 23, 2018
First Posted Date  ICMJE February 20, 2018
Last Update Posted Date August 22, 2019
Actual Study Start Date  ICMJE March 7, 2018
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2019)
  • Tracking and comparison of neurophysiological changes (response size) to functional changes as participants complete 3 months of the ABIW program. [ Time Frame: 3 months ]
    Response size will be measured as amplitude in microvolts. Functional changes will be measured using a proprietary BrainEx Assessment that provides a category score from four cognitive programs of BrainEx.
  • Tracking and comparison of neurophysiological changes (response timing) to functional changes as participants complete 3 months of the ABIW program. [ Time Frame: 3 months ]
    Response timing will be measured as latency in milliseconds. Functional changes will be measured using a proprietary BrainEx Assessment that provides a category score from four cognitive programs of BrainEx.
Original Primary Outcome Measures  ICMJE
 (submitted: February 16, 2018)
  • Tracking and comparison of neurophysiological changes (response size) to functional changes as participants complete 3 months of the WCBH program. [ Time Frame: 3 months ]
    Response size will be measured as amplitude in microvolts. Functional changes will be measured using a proprietary BrainEx Assessment that provides a category score from four cognitive programs of BrainEx.
  • Tracking and comparison of neurophysiological changes (response timing) to functional changes as participants complete 3 months of the WCBH program. [ Time Frame: 3 months ]
    Response timing will be measured as latency in milliseconds. Functional changes will be measured using a proprietary BrainEx Assessment that provides a category score from four cognitive programs of BrainEx.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2018)
Collection and evaluation of adverse events and adverse device effects [ Time Frame: 3 months ]
Evaluate the tolerability and performance of the NeuroCatch Platform™ with individuals who have chronic cognitive deficits due to traumatic brain injury.
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 Brain Changes Throughout the ABI Wellness Program
Official Title  ICMJE Assessing Neurophysiological Changes in Individuals With Chronic Traumatic Brain Injury Symptoms Throughout a Full-time or Part-time Holistic Cognitive Rehabilitation Program: An Initial Assessment.
Brief Summary

Symptoms resulting from mild/moderate trauma to the brain are as varied as the individuals who sustain them. The currently held belief is that the majority of healing and functional recovery occurs within the first two years post injury. A large proportion of individuals who sustain mild/moderate brain injuries (mTBIs) do not fully recover, and continue to experience symptoms well beyond two years post injury. Cognitive rehabilitation programs have been shown to be somewhat effective in helping mTBI patients regain some functionality in these executive domains.

The purpose of the current study is to use an objective assessment of brain function to track changes during either a full-time or part-time holistic cognitive rehabilitation program, specifically the ABI Wellness (ABIW) program. The NeuroCatch Platform™ test will be used to assess brain functioning before, during and after 3 months in the ABIW program. The NeuroCatch Platform™ test uses electroencephalography (EEG) to measure event-related potential (ERP) signals produced by the brain, in response to an auditory stimulus. Three brain processes are examined with this test: Auditory sensation (ERP marker is the N100), Basic attention (ERP marker is the P300), and Cognitive processing (ERP marker is the N400).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants will self-select into one of two treatment conditions: a full-time intensive program or a part-time program. Participants in the full-time program will be asked to complete 4 experimental sessions with the NeuroCatch PlatformTM over the course of 3 months (i.e. one session/ month); whereas, participants in the part-time program will be asked to complete 3 scans over 3 months (i.e. one session/1.5 months).
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Brain Injuries
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: Full-time Cognitive Rehabilitation Program
    Participants in full-time program will be asked to complete 4 experimental sessions with the NeuroCatch Platform™ over the course of 3 months (i.e. one session/ month).
    Intervention: Device: NeuroCatch Platform™
  • Experimental: Part-time Cognitive Rehabilitation Program
    Participants in the part-time program will be asked to complete 3 experimental sessions with the NeuroCatch Platform™ over 3 months (i.e. one session/1.5 months).
    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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 16, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Enrolled in but not initiated the ABI Wellness program
  2. Male or female, 19-65 years old inclusively
  3. Normal hearing capabilities
  4. Able to understand the informed consent form, study procedures and willing to participate in study
  5. Able to keep eyes still for 6 minutes

Exclusion Criteria:

  1. Clinically documented hearing issues (e.g. in-ear hearing problems, punctured ear drum, etc.)
  2. Score of 7 or lower on the Mini Mental State Exam (MMSE) - Orientation subscale
  3. Implanted pacemaker
  4. Metal or plastic implants in skull
  5. In-ear hearing aid or cochlear implant, hearing device
  6. Recent (within last 6 months) acquired brain injury
  7. History of other neurological disorder (e.g. brain cancer, dementia, multiple sclerosis, stroke, etc.)
  8. 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
  9. Not fluent in English language
  10. Unable to provide informed consent
  11. Previous participation in studies using the NeuroCatch Platform™
  12. If female and of child-bearing potential: pregnant, suspected or planning to become pregnant or breast-feeding
  13. History of seizures
  14. 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 No
Contacts  ICMJE
Contact: Christopher Smith 250-715-8344 christophersmith@healthtechconnex.com
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03438851
Other Study ID Numbers  ICMJE NCI_CogRehab_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 August 2019

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