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

Not Applicable

• Conditions: Traumatic Brain Injury; Concussion; Mild Cognitive Disorder
• Interventions: Behavioral: Interactive Trainer-Subject Sessions; Behavioral: Psycho-Social Therapy; Device: Active Control Games; Device: Cognitive Behavioral Computer Training

• Registration Number: NCT02699476
• Lead Sponsor: Brain & Body Health Foundation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-26
• Status Verified: 2016-03
• Study First Submitted QC: 2016-03-03
• Last Update Submitted: 2016-03-03
• Study First Posted: 2016-03-04
• Last Update Posted: 2016-03-04
• Primary Completion: 2017-09
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individual + Computer A	Active Control Games	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.
Group + Computer B	Cognitive Behavioral Computer Training	Daily activities involve group and individual cognitive therapy discussions on health, nutrition, and other topics and computer cognitive training B (CCB).
Individual + Computer A	Interactive Trainer-Subject Sessions	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.
Individual + Computer B	Cognitive Behavioral Computer Training	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.
Individual + Computer B	Interactive Trainer-Subject Sessions	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.
Group + Computer B	Psycho-Social Therapy	Daily activities involve group and individual cognitive therapy discussions on health, nutrition, and other topics and computer cognitive training B (CCB).

Primary Outcome Measures

Name	Time	Method
Participant reported outcomes	within one week following treatment completion.	Measure of impact of program use on the patient's own view of their impairment and function.
Composite performance score based on battery of neuropsychological tests of working memory, learning, memory, and executive function.	within one week following treatment completion	Composite performance score on neuropsychological battery based on four primary domains : learning, memory, working memory, and executive function.
Working/school status	within one week following treatment completion.	Measure of participants' employment status, and the number of hours worked/volunteered/in-school per week.
Exercise-base assessments	within one week following treatment completion.	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.
Functional assessments	within one week following treatment completion.	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.

Trial Locations

Locations (1)

Brain & Body Health Institute, P.A.; 🇺🇸 Lakeway, Texas, United States