Traumatic Brain InjuryBRAVENCT01640158
Broad-spectrum Cognitive Remediation: Effects of a Brain Plasticity-based Program in Mild Traumatic Brain Injury
A study testing Computerized Plasticity-based Adaptive Cognitive Training and Commercially available computerized training in people with Traumatic Brain Injury, run by Posit Science Corporation at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the effects of plasticity-based, adaptive cognitive remediation on the cognitive abilities, functional status and quality of life of soldiers and veterans diagnosed with persistent post-concussive symptoms (PPCS) following a mild traumatic brain injury (mTBI, also… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Computerized Plasticity-based Adaptive Cognitive Training and Commercially available computerized training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to 2 Mar 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects must be 18 - 50 years of age at the time of consent
- Subjects must have a diagnosis of mTBI
- Subjects must have persistent cognitive dysfunction confirmed by an objective measure (as recommended by the ICD-10 definition for post-concussion syndrome) or a subjective measure (as recommended by the DSV-IV definition of post-concussional disorder).
- Subjects must be at least three months out from their most recent TBI, concussion, and/or blast exposure to minimize the effects of spontaneous recovery, as verified through participant interview.
- Subjects must be fluent English speakers.
- Subjects must have adequate sensorimotor capacity to perform the program in the judgment of the consenting clinician.
Who cannot join
- Subjects must not have a history of penetrating head wounds or a diagnosis of moderate or severe TBI.
- Subjects must not be in-patients.
- Subjects must not have a diagnosis of an illness or condition with known cognitive consequences (e.g., schizophrenia, bipolar disorder, cancer, multiple sclerosis).
- Subjects must not show suicidal ideation as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS).
- Subjects must now show signs of intoxication due to current substance abuse (including alcohol and/or illegal drugs) during any in person visit.
- Subjects must not have clinically significant visual field deficits noted by the consenting staff member by direct observation or by medical history.
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- Subjects must not be judged to be lacking effort.
- Subjects must not have problems performing assessments or comprehending or following spoken instructions.
- Subjects must not be enrolled in a concurrent clinical trial involving an investigational pharmaceutical, nutraceutical, medical device, or behavioral treatment for TBI that could affect the outcome of this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Posit Science Corporation
San Francisco, California, 94108
About this study
Official title: BRAVE Trial: Broad-spectrum Cognitive Remediation Available to Veterans: Effects of a Brain Plasticity-based Program in Mild Traumatic Brain Injury (mTBI)
The primary objective of this study is to evaluate the effects of plasticity-based, adaptive cognitive remediation on the cognitive abilities, functional status and quality of life of soldiers and veterans diagnosed with persistent post-concussive symptoms (PPCS) following a mild traumatic brain injury (mTBI, also referred to as a concussion, or blast exposure), as compared to a computer-based control.
Read the detailed description
This study is a multi-site, prospective, parallel arm, double-blind, randomized, controlled clinical trial to assess the safety and efficacy of plasticity-based, adaptive, computerized cognitive remediation treatment versus a computer-based control. Both the study and the cognitive remediation treatments meet the criteria of Non-Significant Risk.
- Conditions
- Traumatic Brain Injury
- Being tested
- Computerized Plasticity-based Adaptive Cognitive Training, Commercially available computerized training
- Keywords
- mild Traumatic Brain Injury, Cognitive remediation, computer
- Medical subject headings
- Brain Injuries, Traumatic, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Plasticity-based Adaptive Cognitive TrainingOther
Computerized plasticity-based adaptive cognitive training, up to 65 hours
Commercially available computerized trainingOther
Commercially available computerized training, up to 65 hours
| Study group | Role | What they receive |
|---|---|---|
| Experimental Treatment | Experimental | Computerized plasticity-based adaptive cognitive training, up to 65 hours Receives: Other: Computerized Plasticity-based Adaptive Cognitive Training |
| Active Comparator | Active comparator | Commercially available computerized training, up to 65 hours Receives: Other: Commercially available computerized training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cognitive Function
Between-group magnitude of change in composite score with the measure constructed from Rey Auditory Verbal Learning Test (RAVLT) sum of trials 1-5 (immediate verbal memory), RAVLT delayed verbal recall, the Ruff Light Trails Test (RULIT) sum of trials 2-10 (immediate visual memory), RULIT delayed recall scores, digit span (WAIS, sum of forwards, backwards, sequencing), symbol span (WMS), anti-saccades, flanker, and set-shifting (each from the EXAMINER battery).
Measured: After three months of training
Change in Functional Performance
Between-group magnitude of change in sum time of all tasks in the Timed Instrumental Activities of Daily Living (TIADL). Higher scores indicate greater impairment in functional performance.
Measured: After three months of training
Secondary outcomes (18)
Change in Mental Health-Related Quality of Life
Between-group magnitude of change in the Mental Component Score (MCS) as measured by the SF-12v2 Health Survey. The component score is a normed-based score with a mean of 50. Scores less than 50 indicate worse mental health than the mean.
Measured: After three months of training and 3 months after training completion
Change in Physical Health-Related Quality of Life
Between-group magnitude of change in the Physical Component Score (PCS) as measured by the SF-12v2 Health Survey. The component score is a normed-based score with a mean of 50. Scores less than 50 indicate worse physical health than the mean.
Measured: After three months of training and 3 months after training completion
Change in Depressive Symptoms
Between-group magnitude of change in sum score using the self-report measure, Beck Depression Inventory (BDI-II). The scoring range is 0-63. Higher scores indicate more severe depressive symptoms.
Measured: After three months of training and 3 months after training completion
Change in PTSD Symptoms
Between-group magnitude of change in sum score using the self-report measure, PTSD Checklist - Civilian Version (PCL-C). The scoring range is 17-85. Higher scores indicate more severe PTSD symptoms.
Measured: After three months of training and 3 months after training completion
Change in Executive Function Symptoms
Between-group magnitude of change in After total T-score using the self-report measure, Frontal Systems Behavior Scale (FrSBe). Raw scores are converted to age- and education-corrected T-scores. The mean T-score is 50, scores greater than 65 are considered clinically significant.
Measured: After three months of training and 3 months after training completion
Change in Cognitive Symptoms
Between-group magnitude of change in sum score using the self-report measure, Cognitive Failures Questionnaire (CFQ). The scoring range is 0-100. Higher scores indicate more severe cognitive symptoms.
Measured: After three months of training and 3 months after training completion
Change in Neurobehavioral Symptoms
Between-group magnitude of change in sum score using the self-report measure, Neurobehavioral Symptoms Index (NSI). The scoring range is 0-88. Higher scores indicate more severe neurobehavioral symptoms.
Measured: After three months of training and 3 months after training completion
Change in TBI Functional Status
Between-group magnitude of change in overall T-score using the self-report measure, Mayo-Portland Adaptability Inventory (MPAI-4). The overall T-score range is -38 to 106. Higher scores indicate more severe TBI functional status.
Measured: After three months of training and 3 months after training completion
Change in Immediate Verbal Memory
Between-group magnitude of change in sum of Trials 1-5 of the Rey Auditory Verbal Learning Test (RAVLT). The scoring range is 0-75. Lower scores indicate greater impairment in immediate verbal memory.
Measured: After three months of training and 3 months after training completion
Change in Delayed Verbal Memory
Between-group magnitude of change in total score of delayed verbal recall on the Rey Auditory Verbal Learning Test (RAVLT). The scoring range is 0-15. Lower scores indicate greater impairment in delayed verbal memory.
Measured: After three months of training and 3 months after training completion
Change in Immediate Visual Memory
Between-group magnitude of change in sum of Trials 2-10 of the Ruff Light Trails Test (RULIT). The scoring range is 0-135. Lower scores indicate greater impairment in immediate visual memory.
Measured: After three months of training and 3 months after training completion
Change in Delayed Visual Memory
Between-group magnitude of change in total score of delayed visual recall on the Ruff Light Trails Test (RULIT). The scoring range is 0-15. Lower scores indicate greater impairment in delayed visual memory.
Measured: After three months of training and 3 months after training completion
Change in Short-Term Verbal Memory Span
Between-group magnitude of change in sum of forwards, backwards, and sequencing tasks of the Wechsler Adult Intelligence Scale (WAIS) 4th Edition - Digit Span. The scoring range is 0-48. Lower scores indicate greater impairment in short-term verbal memory.
Measured: After three months of training and 3 months after training completion
Change in Short-Term Visual Memory Span
Between-group magnitude of change in total score of the Wechsler Memory Scale (WMS) 4th Edition - Symbol Span. The scoring range is 0-50. Lower scores indicate greater impairment in short-term visual memory.
Measured: After three months of training and 3 months after training completion
Change in Inhibition of Reflexive Saccade
Between-group magnitude of change in total score of the Anti-Saccade task of the Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (EXAMINER). The scoring range is 0-40. Lower scores indicate greater impairment in reflexive saccade inhibition.
Measured: After three months of training and 3 months after training completion
Change in Response Inhibition
Between-group magnitude of change in total score of the Flanker task of the Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (EXAMINER). The scoring range is 0-10. Lower scores indicate greater impairment in response inhibition.
Measured: After three months of training and 3 months after training completion
Change in Cognitive Flexibility
Between-group magnitude of change in total score of the Set-Shifting task of the Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (EXAMINER). The scoring range is 0-10. Lower scores indicate greater impairment in mental flexibility.
Measured: After three months of training and 3 months after training completion
Change in Functional Performance
Between-group magnitude of change in sum score of all tasks in the Timed Instrumental Activities of Daily Living (TIADL). Higher scores indicate greater impairment in functional performance.
Measured: 3 months after training completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2012 (estimated)
- Study startSep 2013
- Primary completion2 Mar 2017
- Study completion2 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Posit Science Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Congressionally Directed Medical Research Programs, Walter Reed National Military Medical Center, Tripler Army Medical Center, VA Connecticut Healthcare System, VA Boston Healthcare System, Michael E. DeBakey VA Medical Center
- Responsible party
- Sponsor
- Investigators
- Henry W Mahncke, PhD, Principal investigator, Posit Science CorporationCate N Stasio, BA, Study director, Posit Science Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640158
- Sponsor's protocol ID
- BPI-1002-11
- Acronym
- BRAVE
- Status last verified
- Apr 2019
- First submitted
- 10 Jul 2012
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Consensus conference. Rehabilitation of persons with traumatic brain injury. NIH Consensus Development Panel on Rehabilitation of Persons With Traumatic Brain Injury. JAMA. 1999 Sep 8;282(10):974-83.
PubMed 10485684
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRAVE Trial: Broad-spectrum Cognitive Remediation Available to Veterans: Effects of a Brain Plasticity-based Program in Mild Traumatic Brain Injury (mTBI)
- ClinicalTrials.gov ID
- NCT01640158
- Acronym / sponsor ID
- BRAVE / BPI-1002-11
- Conditions
- Traumatic Brain Injury
- Keywords
- mild Traumatic Brain Injury, Cognitive remediation, computer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Posit Science CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Congressionally Directed Medical Research Programs, Walter Reed National Military Medical Center, Tripler Army Medical Center, VA Connecticut Healthcare System, VA Boston Healthcare System, Michael E. DeBakey VA Medical Center
- Study start
- Sep 2013
- Primary completion
- 2 Mar 2017 (actual)
- Study completion
- 2 Mar 2017 (actual)
- First posted
- 13 Jul 2012 (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 primary objective of this study is to evaluate the effects of plasticity-based, adaptive cognitive remediation on the cognitive abilities, functional status and quality of life of soldiers and veterans diagnosed with persistent post-concussive symptoms (PPCS) following a mild traumatic brain injury (mTBI, also referred to as a concussion, or blast exposure), as compared to a computer-based control.
Detailed description
This study is a multi-site, prospective, parallel arm, double-blind, randomized, controlled clinical trial to assess the safety and efficacy of plasticity-based, adaptive, computerized cognitive remediation treatment versus a computer-based control. Both the study and the cognitive remediation treatments meet the criteria of Non-Significant Risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Treatment | Experimental | Other: Computerized Plasticity-based Adaptive Cognitive TrainingComputerized plasticity-based adaptive cognitive training, up to 65 hours |
| Active Comparator | Active comparator | Other: Commercially available computerized trainingCommercially available computerized training, up to 65 hours |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects must be 18 - 50 years of age at the time of consent
- Subjects must have a diagnosis of mTBI
- Subjects must have persistent cognitive dysfunction confirmed by an objective measure (as recommended by the ICD-10 definition for post-concussion syndrome) or a subjective measure (as recommended by the DSV-IV definition of post-concussional disorder).
- Subjects must be at least three months out from their most recent TBI, concussion, and/or blast exposure to minimize the effects of spontaneous recovery, as verified through participant interview.
- Subjects must be fluent English speakers.
Key exclusion criteria (9 listed)
- Subjects must not have a history of penetrating head wounds or a diagnosis of moderate or severe TBI.
- Subjects must not be in-patients.
- Subjects must not have a diagnosis of an illness or condition with known cognitive consequences (e.g., schizophrenia, bipolar disorder, cancer, multiple sclerosis).
- Subjects must not show suicidal ideation as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS).
- Subjects must now show signs of intoxication due to current substance abuse (including alcohol and/or illegal drugs) during any in person visit.
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 |
|---|---|---|
| Computerized Plasticity-based Adaptive Cognitive TrainingComputerized plasticity-based adaptive cognitive training, up to 65 hours | Other | Experimental Treatment |
| Commercially available computerized trainingCommercially available computerized training, up to 65 hours | Other | Active Comparator |
Primary outcome
Change in Cognitive Function
Time frame: After three months of training
Between-group magnitude of change in composite score with the measure constructed from Rey Auditory Verbal Learning Test (RAVLT) sum of trials 1-5 (immediate verbal memory), RAVLT delayed verbal recall, the Ruff Light Trails Test (RULIT) sum of trials 2-10 (immediate visual memory), RULIT delayed recall scores, digit span (WAIS, sum of forwards, backwards, sequencing), symbol span (WMS), anti-saccades, flanker, and set-shifting (each from the EXAMINER battery).
Change in Functional Performance
Time frame: After three months of training
Between-group magnitude of change in sum time of all tasks in the Timed Instrumental Activities of Daily Living (TIADL). Higher scores indicate greater impairment in functional performance.
18 secondary outcomes
Change in Mental Health-Related Quality of Life
Time frame: After three months of training and 3 months after training completion
Change in Physical Health-Related Quality of Life
Time frame: After three months of training and 3 months after training completion
Change in Depressive Symptoms
Time frame: After three months of training and 3 months after training completion
Change in PTSD Symptoms
Time frame: After three months of training and 3 months after training completion
Change in Executive Function Symptoms
Time frame: After three months of training and 3 months after training completion
Change in Cognitive Symptoms
Time frame: After three months of training and 3 months after training completion
Change in Neurobehavioral Symptoms
Time frame: After three months of training and 3 months after training completion
Change in TBI Functional Status
Time frame: After three months of training and 3 months after training completion
Change in Immediate Verbal Memory
Time frame: After three months of training and 3 months after training completion
Change in Delayed Verbal Memory
Time frame: After three months of training and 3 months after training completion
Change in Immediate Visual Memory
Time frame: After three months of training and 3 months after training completion
Change in Delayed Visual Memory
Time frame: After three months of training and 3 months after training completion
Change in Short-Term Verbal Memory Span
Time frame: After three months of training and 3 months after training completion
Change in Short-Term Visual Memory Span
Time frame: After three months of training and 3 months after training completion
Change in Inhibition of Reflexive Saccade
Time frame: After three months of training and 3 months after training completion
Change in Response Inhibition
Time frame: After three months of training and 3 months after training completion
Change in Cognitive Flexibility
Time frame: After three months of training and 3 months after training completion
Change in Functional Performance
Time frame: 3 months after training completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Background: PubMed 10485684Consensus conference. Rehabilitation of persons with traumatic brain injury. NIH Consensus Development Panel on Rehabilitation of Persons With Traumatic Brain Injury. JAMA. 1999 Sep 8;282(10):974-83.
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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.
Henry W Mahncke, PhD principal investigator
Posit Science Corporation
Cate N Stasio, BA study director
Posit Science Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Plasticity-based Adaptive Cognitive Training and Commercially available computerized training in people with Traumatic Brain Injury, run by Posit Science Corporation 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 9 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: finished, as of the sponsor's last update on 16 Apr 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cognitive Function (time frame: After three months of training). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01640158, which also lists 1 linked publication.
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 16 Apr 2019.