Traumatic Brain InjuryNCT02699476
Enhancing Cognitive and Neurobehavioral Functions After Repetitive Traumatic Brain Injuries (rTBI) in Retired NFL Players and Military Veterans.
A study testing Psycho-Social Therapy, Cognitive Behavioral Computer Training and Interactive Trainer-Subject Sessions in people with Traumatic Brain Injury and Concussion, run by Brain & Body Health Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Concussion, Mild Cognitive Disorder
- What is being tested?
- Psycho-Social Therapy, Cognitive Behavioral Computer Training and Interactive Trainer-Subject Sessions
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Brain & Body Health Institute, P.A.
Lakeway, Texas, 78734
About this study
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
- Being tested
- Psycho-Social Therapy, Cognitive Behavioral Computer Training, Interactive Trainer-Subject Sessions, Active Control Games
- Keywords
- NFL, veterans, cognitive training, TBI, concussion
- Medical subject headings
- Brain Injuries, Traumatic, Brain Concussion, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psycho-Social TherapyBehavioural
Cognitive Behavioral Computer TrainingDevice
Also called BrainHQ
Interactive Trainer-Subject SessionsBehavioural
Also called LearningRx
Active Control GamesDevice
| Study group | Role | What they receive |
|---|---|---|
| Individual + Computer A | Active comparator | 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. Receives: Behavioral: Interactive Trainer-Subject Sessions; Device: Active Control Games |
| Individual + Computer B | Experimental | 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. Receives: Device: Cognitive Behavioral Computer Training; Behavioral: Interactive Trainer-Subject Sessions |
| Group + Computer B | Active comparator | Daily activities involve group and individual cognitive therapy discussions on health, nutrition, and other topics and computer cognitive training B (CCB). Receives: Behavioral: Psycho-Social Therapy; Device: Cognitive Behavioral Computer Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: within one week following treatment completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionSep 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brain & Body Health Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert W. Van Boven, M.D., D.D.S., Brain & Body Health Foundation
- Investigators
- Robert W Van Boven, M.D., D.D.S., Principal investigator, Brain & Body Health Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02699476
- Sponsor's protocol ID
- BBHF-001
- Status last verified
- Mar 2016
- First submitted
- 26 Feb 2016
- Last updated
- 4 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Cognitive and Neurobehavioral Functions After Repetitive Traumatic Brain Injuries (rTBI) in Retired NFL Players and Military Veterans.
- ClinicalTrials.gov ID
- NCT02699476
- Acronym / sponsor ID
- BBHF-001
- Conditions
- Traumatic Brain Injury, Concussion, Mild Cognitive Disorder
- Keywords
- NFL, veterans, cognitive training, TBI, concussion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Brain & Body Health FoundationUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 4 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Individual + Computer A | Active comparator | Behavioral: Interactive Trainer-Subject Sessions, Device: Active Control GamesDaily 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 | Experimental | Device: Cognitive Behavioral Computer Training, Behavioral: Interactive Trainer-Subject SessionsDaily 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 comparator | Behavioral: Psycho-Social Therapy, Device: Cognitive Behavioral Computer TrainingDaily activities involve group and individual cognitive therapy discussions on health, nutrition, and other topics and computer cognitive training B (CCB). |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psycho-Social Therapy | Behavioural | Group + Computer B |
| Cognitive Behavioral Computer TrainingAlso: BrainHQ | Device | Group + Computer B, Individual + Computer B |
| Interactive Trainer-Subject SessionsAlso: LearningRx | Behavioural | Individual + Computer A, Individual + Computer B |
| Active Control Games | Device | Individual + Computer A |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert W Van Boven, M.D., D.D.S. principal investigator
Brain & Body Health Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psycho-Social Therapy, Cognitive Behavioral Computer Training and Interactive Trainer-Subject Sessions in people with Traumatic Brain Injury and Concussion, run by Brain & Body Health Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert W Van Boven, M.D., D.D.S. (512-981-5801, brainbodyhealthfoundation@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2016.