Enhancing Cognitive and Neurobehavioral Functions After Repetitive Traumatic Brain Injuries (rTBI) in Retired NFL Players and Military Veterans.
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 26, 2016
CompletedFirst Posted
Study publicly available on registry
March 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMarch 4, 2016
March 1, 2016
1.6 years
February 26, 2016
March 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Composite performance score based on battery of neuropsychological tests of working memory, learning, memory, and executive function.
Composite performance score on neuropsychological battery based on four primary domains : learning, memory, working memory, and executive function.
within one week following treatment completion
Participant reported outcomes
Measure of impact of program use on the patient's own view of their impairment and function.
within one week following treatment completion.
Working/school status
Measure of participants' employment status, and the number of hours worked/volunteered/in-school per week.
within one week following treatment completion.
Exercise-base assessments
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.
within one week following treatment completion.
Functional assessments
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.
within one week following treatment completion.
Study Arms (3)
Individual + Computer A
ACTIVE COMPARATORDaily 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.
Individual + Computer B
EXPERIMENTALDaily 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 + Computer B
ACTIVE COMPARATORDaily activities involve group and individual cognitive therapy discussions on health, nutrition, and other topics and computer cognitive training B (CCB).
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brain & Body Health Institute, P.A.
Lakeway, Texas, 78734, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert W Van Boven, M.D., D.D.S.
Brain & Body Health Foundation
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
February 26, 2016
First Posted
March 4, 2016
Study Start
February 1, 2016
Primary Completion
September 1, 2017
Study Completion
December 1, 2017
Last Updated
March 4, 2016
Record last verified: 2016-03
Data Sharing
- IPD Sharing
- Will not share