Concussion, Mild Cognitive Disorder, Traumatic Brain Injury
Conditions
Keywords
NFL, veterans, cognitive training, TBI, concussion
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.
Interventions
BEHAVIORALPsycho-Social Therapy
DEVICECognitive Behavioral Computer Training
BEHAVIORALInteractive Trainer-Subject Sessions
DEVICEActive Control Games
Sponsors
Brain & Body Health Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
United States
Contacts
Primary ContactRobert W Van Boven, M.D., D.D.S.
Backup ContactMark R Taylor, Ph.D.
Outcome results
None listed