Clinical trial NCT02699476: Enhancing Cognitive and Neurobehavioral Functions After Repetitive Traumatic Brain Injuries (rTBI) in Retired NFL Players and Military Veterans.
Official title: Enhancing Cognitive and Neurobehavioral Functions After Repetitive Traumatic Brain Injuries (rTBI) in Retired NFL Players and Military Veterans.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Traumatic Brain Injury
Concussion
Mild Cognitive Disorder
Keywords: NFL
veterans
cognitive training
TBI
concussion
Lead sponsor: Brain & Body Health Foundation
Sponsor class: OTHER
First posted: 2016-03-04
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Composite performance score based on battery of neuropsychological tests of working memory, learning, memory, and executive function.
timeFrame: within one week following treatment completion
measure: Participant reported outcomes
timeFrame: within one week following treatment completion.
measure: Working/school status
timeFrame: within one week following treatment completion.
measure: Exercise-base assessments
timeFrame: within one week following treatment completion.
measure: Functional assessments
timeFrame: within one week following treatment completion.
Secondary outcomes:
Other outcomes:
Locations:
city: Lakeway
country: United States
facility: Brain & Body Health Institute, P.A.
state: Texas
Study officials:
affiliation: Brain & Body Health Foundation
name: Robert W Van Boven, M.D., D.D.S.
role: PRINCIPAL_INVESTIGATOR
References: