Back to resultsBroad-spectrum Cognitive Remediation: Effects of a Brain Plasticity-based Program in Mild Traumatic Brain Injury (BRAVE)
Primary Purpose
Traumatic Brain Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized Plasticity-based Adaptive Cognitive Training
Commercially available computerized training
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring mild Traumatic Brain Injury, Cognitive remediation, computer
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Posit Science Corporation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental Treatment
Active Comparator
Arm Description
Computerized plasticity-based adaptive cognitive training, up to 65 hours
Commercially available computerized training, up to 65 hours
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT01640158
First Posted
July 10, 2012
Last Updated
April 11, 2019
Sponsor
Posit Science Corporation
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
1. Study Identification
Unique Protocol Identification Number
NCT01640158
Brief Title
Broad-spectrum Cognitive Remediation: Effects of a Brain Plasticity-based Program in Mild Traumatic Brain Injury
Acronym
BRAVE
Official Title
BRAVE Trial: Broad-spectrum Cognitive Remediation Available to Veterans: Effects of a Brain Plasticity-based Program in Mild Traumatic Brain Injury (mTBI)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
March 2, 2017 (Actual)
Study Completion Date
March 2, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Posit Science Corporation
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
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
mild Traumatic Brain Injury, Cognitive remediation, computer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Treatment
Arm Type
Experimental
Arm Description
Computerized plasticity-based adaptive cognitive training, up to 65 hours
Arm Title
Active Comparator
Arm Type
Active Comparator
Arm Description
Commercially available computerized training, up to 65 hours
Intervention Type
Other
Intervention Name(s)
Computerized Plasticity-based Adaptive Cognitive Training
Intervention Description
Computerized plasticity-based adaptive cognitive training, up to 65 hours
Intervention Type
Other
Intervention Name(s)
Commercially available computerized training
Intervention Description
Commercially available computerized training, up to 65 hours
Primary Outcome Measure Information:
Title
Change in Cognitive Function
Description
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).
Time Frame
After three months of training
Title
Change in Functional Performance
Description
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.
Time Frame
After three months of training
Secondary Outcome Measure Information:
Title
Change in Mental Health-Related Quality of Life
Description
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.
Time Frame
After three months of training and 3 months after training completion
Title
Change in Physical Health-Related Quality of Life
Description
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.
Time Frame
After three months of training and 3 months after training completion
Title
Change in Depressive Symptoms
Description
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.
Time Frame
After three months of training and 3 months after training completion
Title
Change in PTSD Symptoms
Description
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.
Time Frame
After three months of training and 3 months after training completion
Title
Change in Executive Function Symptoms
Description
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.
Time Frame
After three months of training and 3 months after training completion
Title
Change in Cognitive Symptoms
Description
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.
Time Frame
After three months of training and 3 months after training completion
Title
Change in Neurobehavioral Symptoms
Description
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.
Time Frame
After three months of training and 3 months after training completion
Title
Change in TBI Functional Status
Description
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.
Time Frame
After three months of training and 3 months after training completion
Title
Change in Immediate Verbal Memory
Description
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.
Time Frame
After three months of training and 3 months after training completion
Title
Change in Delayed Verbal Memory
Description
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.
Time Frame
After three months of training and 3 months after training completion
Title
Change in Immediate Visual Memory
Description
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.
Time Frame
After three months of training and 3 months after training completion
Title
Change in Delayed Visual Memory
Description
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.
Time Frame
After three months of training and 3 months after training completion
Title
Change in Short-Term Verbal Memory Span
Description
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.
Time Frame
After three months of training and 3 months after training completion
Title
Change in Short-Term Visual Memory Span
Description
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.
Time Frame
After three months of training and 3 months after training completion
Title
Change in Inhibition of Reflexive Saccade
Description
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.
Time Frame
After three months of training and 3 months after training completion
Title
Change in Response Inhibition
Description
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.
Time Frame
After three months of training and 3 months after training completion
Title
Change in Cognitive Flexibility
Description
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.
Time Frame
After three months of training and 3 months after training completion
Title
Change in Functional Performance
Description
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.
Time Frame
3 months after training completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry W Mahncke, PhD
Organizational Affiliation
Posit Science Corporation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cate N Stasio, BA
Organizational Affiliation
Posit Science Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Posit Science Corporation
City
San Francisco
State/Province
California
ZIP/Postal Code
94108
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
10485684
Citation
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.
Results Reference
background
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Broad-spectrum Cognitive Remediation: Effects of a Brain Plasticity-based Program in Mild Traumatic Brain Injury
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