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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Traumatic Brain Injury Concussion Mild Cognitive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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.

Group Type ACTIVE_COMPARATOR

Interactive Trainer-Subject Sessions

Intervention Type BEHAVIORAL

Active Control Games

Intervention Type DEVICE

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.

Group Type EXPERIMENTAL

Cognitive Behavioral Computer Training

Intervention Type DEVICE

Interactive Trainer-Subject Sessions

Intervention Type BEHAVIORAL

Group + Computer B

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

Group Type ACTIVE_COMPARATOR

Psycho-Social Therapy

Intervention Type BEHAVIORAL

Cognitive Behavioral Computer Training

Intervention Type DEVICE

Interventions

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Psycho-Social Therapy

Intervention Type BEHAVIORAL

Cognitive Behavioral Computer Training

Intervention Type DEVICE

Interactive Trainer-Subject Sessions

Intervention Type BEHAVIORAL

Active Control Games

Intervention Type DEVICE

Other Intervention Names

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BrainHQ LearningRx

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brain & Body Health Foundation

OTHER

Sponsor Role lead

Responsible Party

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Robert W. Van Boven, M.D., D.D.S.

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Robert W Van Boven, M.D., D.D.S.

Role: CONTACT

512-981-5801

Mark R Taylor, Ph.D.

Role: CONTACT

586-945-6618

Other Identifiers

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BBHF-001

Identifier Type: -

Identifier Source: org_study_id

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