Recruiting

Cognitive Enhancement

Sponsor:

Brain & Body Health Foundation

Code:

NCT02699476

Conditions

Traumatic Brain Injury

Concussion

Mild Cognitive Disorder

Eligibility Criteria

Sex: All

Age: 25 - 55

Healthy Volunteers: Accepted

Interventions

Psycho-Social Therapy

Cognitive Behavioral Computer Training

Interactive Trainer-Subject Sessions

Active Control Games

Study Details

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.

Conditions

Traumatic Brain Injury

Concussion

Mild Cognitive Disorder

Study ID

NCT02699476

Start date

Feb, 2016

Status verified date

Mar, 2016

Completion date

Dec, 2017

Anticipated

Primary completion date

Sep, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 55

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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).

Interventions

Psycho-Social Therapy

Cognitive Behavioral Computer Training

Interactive Trainer-Subject Sessions

Active Control Games

Primary outcome measure

  • 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 ]
  • Participant reported outcomes [ Time Frame: within one week following treatment completion. ]
  • Working/school status [ Time Frame: within one week following treatment completion. ]
  • Exercise-base assessments [ Time Frame: within one week following treatment completion. ]
  • Functional assessments [ Time Frame: within one week following treatment completion. ]

Central Contacts and Locations

Central contacts

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

512-981-5801brainbodyhealthfoundation@gmail.com

Mark R Taylor, Ph.D.

586-945-6618mtaylormich@gmail.com

Locations

Brain & Body Health Institute, P.A.

Recruiting

Lakeway, Texas, United States, 78734

More Information

Sponsor

Brain & Body Health Foundation

Last update posted

Mar 4, 2016

Last verified

Mar, 2016

Keywords

  • NFL
  • veterans
  • cognitive training
  • TBI
  • concussion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Brain & Body Health Foundation on 2016-03-04.