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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 : Terminated (NeuroCatch Platform became commercially available (Health Canada License approved) and can now be incorporated into the ABI Wellness Program)
First Posted : February 20, 2018
Last Update Posted : March 18, 2021
Sponsor:
Information provided by (Responsible Party):
NeuroCatch Inc.

Study Description
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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).


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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
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
Official Title: 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.
Actual Study Start Date : March 7, 2018
Actual Primary Completion Date : April 21, 2020
Actual Study Completion Date : April 21, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
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Arm Intervention/treatment
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).
 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.
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).
 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. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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): NCT03438851


Locations
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Canada, British Columbia
HealthTech Connex Inc. Centre for Neurology Studies
Surrey, British Columbia, Canada, V3V 0C6
Sponsors and Collaborators
NeuroCatch Inc.
Investigators
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Principal Investigator: Jan Venter, MBChB MFamMed CCFP IFMCP HealthTech Connex Inc. Centre for Neurology Studies
More Information
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Responsible Party: NeuroCatch Inc.
ClinicalTrials.gov Identifier: NCT03438851    
Other Study ID Numbers: NCI_CogRehab_001
First Posted: February 20, 2018    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
Additional relevant MeSH terms:
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Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries