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

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ClinicalTrials.gov Identifier: NCT02699476
Recruitment Status : Unknown
Verified March 2016 by Robert W. Van Boven, M.D., D.D.S., Brain & Body Health Foundation.
Recruitment status was:  Recruiting
First Posted : March 4, 2016
Last Update Posted : March 4, 2016
Sponsor:
Information provided by (Responsible Party):
Robert W. Van Boven, M.D., D.D.S., Brain & Body Health Foundation

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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Concussion Mild Cognitive Disorder Behavioral: Psycho-Social Therapy Device: Cognitive Behavioral Computer Training Behavioral: Interactive Trainer-Subject Sessions Device: Active Control Games Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhancing Cognitive and Neurobehavioral Functions After Repetitive Traumatic Brain Injuries (rTBI) in Retired NFL Players and Military Veterans.
Study Start Date : February 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Behavioral: Interactive Trainer-Subject Sessions
Other Name: LearningRx

Device: Active Control Games
Experimental: 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.
Device: Cognitive Behavioral Computer Training
Other Name: BrainHQ

Behavioral: Interactive Trainer-Subject Sessions
Other Name: LearningRx

Active Comparator: Group + Computer B
Daily activities involve group and individual cognitive therapy discussions on health, nutrition, and other topics and computer cognitive training B (CCB).
Behavioral: Psycho-Social Therapy
Device: Cognitive Behavioral Computer Training
Other Name: BrainHQ




Primary Outcome Measures :
  1. Composite performance score based on battery of neuropsychological tests of working memory, learning, memory, and executive function. [ Time Frame: within one week following treatment completion ]
    Composite performance score on neuropsychological battery based on four primary domains : learning, memory, working memory, and executive function.

  2. Participant reported outcomes [ Time Frame: within one week following treatment completion. ]
    Measure of impact of program use on the patient's own view of their impairment and function.

  3. Working/school status [ Time Frame: within one week following treatment completion. ]
    Measure of participants' employment status, and the number of hours worked/volunteered/in-school per week.

  4. Exercise-base assessments [ Time Frame: within one week following treatment completion. ]
    Four sets of assessments that are closely modeled on study-related exercises in the auditory, visual, cognitive, and social-cognitive modules. These include auditory speed of processing, visual speed of processing, cognitive control speed of processing and face recognition, recall of unique faces, and emotional cue recognition.

  5. Functional assessments [ Time Frame: within one week following treatment completion. ]
    Timed instrumental activities of daily living (TIADL) and the Mayo-Portland Adaptability Inventory (MPAI-4) for sensitive directly observed performance and well-accepted clinical impression measures.



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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699476


Contacts
Contact: Robert W Van Boven, M.D., D.D.S. 512-981-5801 brainbodyhealthfoundation@gmail.com
Contact: Mark R Taylor, Ph.D. 586-945-6618 mtaylormich@gmail.com

Locations
United States, Texas
Brain & Body Health Institute, P.A. Recruiting
Lakeway, Texas, United States, 78734
Sponsors and Collaborators
Brain & Body Health Foundation
Investigators
Principal Investigator: Robert W Van Boven, M.D., D.D.S. Brain & Body Health Foundation

Responsible Party: Robert W. Van Boven, M.D., D.D.S., Director, Brain & Body Health Foundation
ClinicalTrials.gov Identifier: NCT02699476     History of Changes
Other Study ID Numbers: BBHF-001
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: March 4, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Robert W. Van Boven, M.D., D.D.S., Brain & Body Health Foundation:
NFL
veterans
cognitive training
TBI
concussion

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Cognition Disorders
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Neurocognitive Disorders
Mental Disorders