BRAVE Trial: Broad-spectrum Cognitive Remediation Available to Veterans: Effects of a Brain Plasticity-based Program in Mild Traumatic Brain Injury (mTBI)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Posit Science Corporation
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Change in Functional Performance
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Experimental Treatment
Computerized plasticity-based adaptive cognitive training, up to 65 hours
Intervention: Computerized Plasticity-based Adaptive Cognitive Training (Other)
Active Comparator
Commercially available computerized training, up to 65 hours
Intervention: Commercially available computerized training (Other)
Outcomes
Primary Outcomes
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.
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).
Secondary Outcomes
- Change in Short-Term Visual Memory Span(After three months of training and 3 months after training completion)
- Change in Cognitive Symptoms(After three months of training and 3 months after training completion)
- Change in Physical Health-Related Quality of Life(After three months of training and 3 months after training completion)
- Change in Neurobehavioral Symptoms(After three months of training and 3 months after training completion)
- Change in PTSD Symptoms(After three months of training and 3 months after training completion)
- Change in Executive Function Symptoms(After three months of training and 3 months after training completion)
- Change in Immediate Verbal Memory(After three months of training and 3 months after training completion)
- Change in Depressive Symptoms(After three months of training and 3 months after training completion)
- Change in TBI Functional Status(After three months of training and 3 months after training completion)
- Change in Delayed Verbal Memory(After three months of training and 3 months after training completion)
- Change in Immediate Visual Memory(After three months of training and 3 months after training completion)
- Change in Short-Term Verbal Memory Span(After three months of training and 3 months after training completion)
- Change in Response Inhibition(After three months of training and 3 months after training completion)
- Change in Mental Health-Related Quality of Life(After three months of training and 3 months after training completion)
- Change in Delayed Visual Memory(After three months of training and 3 months after training completion)
- Change in Cognitive Flexibility(After three months of training and 3 months after training completion)
- Change in Functional Performance(3 months after training completion)
- Change in Inhibition of Reflexive Saccade(After three months of training and 3 months after training completion)