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

Status unconfirmed · Not applicable

Conditions studied: Traumatic Brain Injury, Concussion, Mild Cognitive Disorder

In brief

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.

Key facts

Study ID

NCT02699476

Run by

Brain & Body Health Foundation

People needed

60

Starts

2016-02-01

Expected to finish

2017-12-01

Last updated by the study team

2016-03-04

Who can join

Age: 25 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Brain & Body Health Institute, P.A. — Lakeway, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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