Assessing Brain Changes Throughout the ABI Wellness Program

Study Overview
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Brief Summary
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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 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).

Official Title
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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.

Conditions
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Brain Injuries

Intervention / Treatment
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* Device: NeuroCatch Platform™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrolled in but not initiated the ABI Wellness program Male or female, 19-65 years old inclusively Normal hearing capabilities Able to understand the informed consent form, study procedures and willing to participate in study Able to keep eyes still for 6 minutes Exclusion Criteria: Clinically documented hearing issues (e.g. in-ear hearing problems, punctured ear drum, etc.) Score of 7 or lower on the Mini Mental State Exam (MMSE) - Orientation subscale Implanted pacemaker Metal or plastic implants in skull In-ear hearing aid or cochlear implant, hearing device Recent (within last 6 months) acquired brain injury History of other neurological disorder (e.g. brain cancer, dementia, multiple sclerosis, stroke, etc.) 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 Not fluent in English language Unable to provide informed consent Previous participation in studies using the NeuroCatch Platform™ If female and of child-bearing potential: pregnant, suspected or planning to become pregnant or breast-feeding History of seizures Allergy to rubbing alcohol or EEG gel

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Full-time Cognitive Rehabilitation Program<br>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™<br>* 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.<br>|
| Experimental: Part-time Cognitive Rehabilitation Program<br>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™<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection and evaluation of adverse events and adverse device effects | Evaluate the tolerability and performance of the NeuroCatch Platform™ with individuals who have chronic cognitive deficits due to traumatic brain injury. | 3 months |