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NeuroCatch Platform became commercially available (Health Canada License approved) and can now be incorporated into the ABI Wellness Program
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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 Platformâ„¢ test will be used to assess brain functioning before, during and after 3 months in the ABIW program. The NeuroCatch Platformâ„¢ 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full-time Cognitive Rehabilitation Program | Experimental | Participants in full-time program will be asked to complete 4 experimental sessions with the NeuroCatch Platformâ„¢ over the course of 3 months (i.e. one session/ month). |
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| Part-time Cognitive Rehabilitation Program | Experimental | Participants in the part-time program will be asked to complete 3 experimental sessions with the NeuroCatch Platformâ„¢ over 3 months (i.e. one session/1.5 months). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeuroCatch Platformâ„¢ | Device | NeuroCatch Platformâ„¢ 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Tracking and comparison of neurophysiological changes (response size) to functional changes as participants complete 3 months of the ABIW program. | 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. | 3 months |
| Tracking and comparison of neurophysiological changes (response timing) to functional changes as participants complete 3 months of the ABIW program. | 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Collection and evaluation of adverse events and adverse device effects | Evaluate the tolerability and performance of the NeuroCatch Platformâ„¢ with individuals who have chronic cognitive deficits due to traumatic brain injury. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Venter, MBChB MFamMed CCFP IFMCP | HealthTech Connex Inc. Centre for Neurology Studies | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HealthTech Connex Inc. Centre for Neurology Studies | Surrey | British Columbia | V3V 0C6 | Canada |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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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).
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| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |