Enhancing Cognitive and Neurobehavioral Functions After Repetitive Traumatic Brain Injuries (rTBI) in Retired NFL Players and Military Veterans.

Study Overview
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Brief Summary
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The purpose of this study is to compare different combinations of cognitive training in retired professional football players and military veterans with a history of repeated concussions and persistent symptoms of impaired memory, concentration, attention, focus, or thinking.

Official Title
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Enhancing Cognitive and Neurobehavioral Functions After Repetitive Traumatic Brain Injuries (rTBI) in Retired NFL Players and Military Veterans.

Conditions
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Traumatic Brain Injury, Concussion, Mild Cognitive Disorder

Intervention / Treatment
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* Behavioral: Psycho-Social Therapy
* Device: Cognitive Behavioral Computer Training
* Behavioral: Interactive Trainer-Subject Sessions
* Device: Active Control Games


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of >1 Mild TBI: post traumatic amnesia/confusion ≤ 24 hour immediately after injury; or loss of consciousness <30 min confirmed by the Ohio State University TBI Identification Method-Short Form (OSU TBI-ID-SF). Age 25-55 years Minimum of 4 months post-injury Adequate visual, auditory, sensory-motor function for training program. Fluent in English Persistent cognitive dysfunction confirmed by Ruff Neurobehavioral Inventory score of greater than 70 on any of the four cognitive scales (Attention, Memory, Language, Executive). Exclusion Criteria: History of hypoxic event Pre-existing significant neurological (e.g. MS) or psychiatric (e.g. schizophrenia, bi-polar) disorders. Current illicit drug use or alcohol abuse Unwilling or unable (e.g. language barrier) to participate Hospitalization during study Current Litigation Positive on malingering test Use of medications to enhance cognitive function (e.g. Ritalin) Initial Glasgow Coma Score < 13 or penetrating head injury Subjects must not show suicidal ideation as measured by the Columbia-Suicide Severity Rating Scale. Subjects with a score of 4 or 5 (as recommended by the FDA for treatment trials) will be excluded and referred for appropriate treatment. Subjects should not be enrolled in a concurrent TBI clinical trial.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Individual + Computer A<br>Daily activities involve playing one hour of computer games (e.g., hangman, boggle, word scramble, chess; computer cognitive training A (CCA)), and two (2) 90 minute individual training sessions interacting one-on-one with a trainer in a variety of cognitive tasks including attention, memory, and comprehension of information. | Behavioral: Interactive Trainer-Subject Sessions<br> <br> * Other names: LearningRx;Device: Active Control Games<br> <br> |
| Experimental: Individual + Computer B<br>Daily activities involve playing an alternative set of computer games (computer cognitive training B (CCB)), and two (2) 90 minute individual training sessions interacting one-on-one with a trainer in a variety of cognitive tasks including attention, memory, and comprehension of information. | Device: Cognitive Behavioral Computer Training<br> <br> * Other names: BrainHQ;Behavioral: Interactive Trainer-Subject Sessions<br> <br> * Other names: LearningRx;|
| Active Comparator: Group + Computer B<br>Daily activities involve group and individual cognitive therapy discussions on health, nutrition, and other topics and computer cognitive training B (CCB). | Behavioral: Psycho-Social Therapy<br> <br> Device: Cognitive Behavioral Computer Training<br> <br> * Other names: BrainHQ;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite performance score based on battery of neuropsychological tests of working memory, learning, memory, and executive function. | Composite performance score on neuropsychological battery based on four primary domains : learning, memory, working memory, and executive function. | within one week following treatment completion | 
| Participant reported outcomes | Measure of impact of program use on the patient's own view of their impairment and function. | within one week following treatment completion. | 
| Working/school status | Measure of participants' employment status, and the number of hours worked/volunteered/in-school per week. | within one week following treatment completion. | 
| Exercise-base assessments | Four sets of assessments that are closely modeled on study-related exercises in the auditory, visual, cognitive, and social-cognitive modules. These include auditory speed of processing, visual speed of processing, cognitive control speed of processing and face recognition, recall of unique faces, and emotional cue recognition. | within one week following treatment completion. | 
| Functional assessments | Timed instrumental activities of daily living (TIADL) and the Mayo-Portland Adaptability Inventory (MPAI-4) for sensitive directly observed performance and well-accepted clinical impression measures. | within one week following treatment completion. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NFL, veterans, cognitive training, TBI, concussion