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

Brain & Body Health Foundation

Status: Unknown

Conditions: Traumatic Brain Injury; Concussion; Mild Cognitive Disorder

Treatments: Device: Cognitive Behavioral Computer Training; Behavioral: Psycho-Social Therapy; Behavioral: Interactive Trainer-Subject Sessions; Device: Active Control Games

Study type: Interventional

Funder types: Other

Identifiers

NCT02699476

BBHF-001

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 25 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

Individual + Computer A

Active Comparator group

Description:

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.

Treatment:

Behavioral: Interactive Trainer-Subject Sessions

Device: Active Control Games

Individual + Computer B

Experimental group

Description:

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.

Treatment:

Behavioral: Interactive Trainer-Subject Sessions

Device: Cognitive Behavioral Computer Training

Group + Computer B

Active Comparator group

Description:

Daily activities involve group and individual cognitive therapy discussions on health, nutrition, and other topics and computer cognitive training B (CCB).

Treatment:

Behavioral: Psycho-Social Therapy

Device: Cognitive Behavioral Computer Training