Enhancing Cognitive and Neurobehavioral Functions After Repetitive Traumatic Brain Injuries (rTBI) in Retired NFL Players and Military Veterans.
NCT ID: NCT02699476
Last Updated: 2016-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2016-02-29
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Individual + Computer A
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.
Interactive Trainer-Subject Sessions
Active Control Games
Individual + Computer B
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.
Cognitive Behavioral Computer Training
Interactive Trainer-Subject Sessions
Group + Computer B
Daily activities involve group and individual cognitive therapy discussions on health, nutrition, and other topics and computer cognitive training B (CCB).
Psycho-Social Therapy
Cognitive Behavioral Computer Training
Interventions
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Psycho-Social Therapy
Cognitive Behavioral Computer Training
Interactive Trainer-Subject Sessions
Active Control Games
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
25 Years
55 Years
ALL
Yes
Sponsors
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Brain & Body Health Foundation
OTHER
Responsible Party
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Robert W. Van Boven, M.D., D.D.S.
Director
Principal Investigators
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Robert W Van Boven, M.D., D.D.S.
Role: PRINCIPAL_INVESTIGATOR
Brain & Body Health Foundation
Locations
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Brain & Body Health Institute, P.A.
Lakeway, Texas, United States
Countries
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Central Contacts
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Other Identifiers
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BBHF-001
Identifier Type: -
Identifier Source: org_study_id
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