Cognitive Rehabilitation for Traumatic Brain Injury
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VA Office of Research and Development
Must not be taking: Psychotropics
Disqualifiers: Severe cognitive dysfunction, Schizophrenia, Bipolar, Neurological disorders, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
For many Veterans, success in achieving goals at work, school and in other aspects of life are top priorities. The abilities to regulate attention, remember key information, and stay calm and on track are fundamental to this success. Unfortunately, Veterans who have experienced a traumatic brain injury (TBI) often struggle with these very abilities, and a number of barriers can make it difficult for them to access the help Veterans need. Tele-rehabilitation has the potential to overcome some of these barriers and increase access to care, enabling providers to better reach Veterans 'where they are' in their communities. This project will assess two different approaches to brain injury rehabilitation that seek to help Veterans build personal strengths to better accomplish their goals. Both approaches will be delivered remotely via tele-rehabilitation and augmented by digital apps to best support Veterans' learning in community settings outside the VA.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it mentions that participants should not have active changes in psychotropic medications (drugs affecting mood, perception, or behavior). It's best to discuss your specific medications with the trial coordinators.
What data supports the effectiveness of the treatment BrainStrong-GSR, BrainStrong-OPT for cognitive rehabilitation in traumatic brain injury?
Research shows that computerized brain training programs can help improve cognitive function in people with traumatic brain injury. Studies found that these programs can lead to small to moderate improvements in thinking skills and daily functioning, suggesting they could be a useful part of rehabilitation.12345
Is cognitive rehabilitation for traumatic brain injury safe for humans?
The studies suggest that cognitive rehabilitation tools, including computer-based programs and virtual reality simulations, are generally safe for humans. Participants reported mild fatigue that improved over time, and there were few technical difficulties, indicating that these interventions can be safely used at home with remote support.12678
How does the BrainStrong treatment for traumatic brain injury differ from other treatments?
The BrainStrong treatment for traumatic brain injury is unique because it likely incorporates elements of cognitive rehabilitation that may include exercise, virtual reality, and computer-based brain training, which are designed to improve cognitive function and can be administered at home. This approach is different from traditional therapies that often require in-person sessions and may not be as adaptable to mild traumatic brain injuries.12346
Eligibility Criteria
This trial is for post-9/11 Veterans aged 21-60 who have had a mild to moderate traumatic brain injury and are at least six months into recovery. They should experience cognitive symptoms like memory issues and be interested in goal-setting and training. It's not suitable for those with severe mental health conditions, other neurological disorders, or ongoing medical issues that could affect participation.Inclusion Criteria
I have had a mild to moderate traumatic brain injury.
I am between 21 and 60 years old and have had a mild to moderate traumatic brain injury.
I am over 6 months post-injury, have memory issues, and am open to intensive training.
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Exclusion Criteria
Severe cognitive dysfunction (below 2 standard deviations on two composite cognitive domains)
Current medical illnesses that may alter mental status or disrupt participation in the study
Symptom magnification or malingering
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either Goal-directed State Regulation Training (GSR) or Optimization of Brain Functioning (OPT) via tele-rehabilitation, augmented by digital apps
5 weeks
Remote sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at 3 months post-intervention
3 months
In-person assessments
Treatment Details
Interventions
- BrainStrong-GSR (Behavioural Intervention)
- BrainStrong-OPT (Behavioural Intervention)
Trial OverviewThe study tests two remote rehabilitation methods delivered via tele-rehabilitation supported by digital apps: BrainStrong-OPT and BrainStrong-GSR. These interventions aim to help Veterans improve attention regulation, memory retention, and emotional control to achieve their life goals.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: BrainStrong-GSRExperimental Treatment1 Intervention
Goal-directed State Regulation Training (GSR)
Group II: BrainStrong-OPTActive Control1 Intervention
Optimization of Brain Functioning (OPT)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
VA Northern California Health Care System, Mather, CASacramento, CA
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Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
References
Feasibility of computerized brain plasticity-based cognitive training after traumatic brain injury. [2019]The present study investigates the feasibility and utility of using a computerized brain plasticity-based cognitive training (BPCT) program as an intervention for community-dwelling individuals with traumatic brain injury (TBI). In a pre-post pilot study, 10 individuals with mild to severe TBI who were 6 mo to 22 yr postinjury were asked to use a computerized BPCT intervention-designed to improve cognitive functioning through a graduated series of structured exercises-at their homes in an urban community. Outcome measures included objective neuropsychological and self-report measures of cognitive functioning. All participants were able to use the software in their homes. Some mild fatigue was reported, which tended to dissipate over time. Few technical difficulties were reported. Remote support was sufficient for what technical assistance was needed. Participants reported subjective improvement in cognitive functioning, and small to large effect sizes on self-report and neuropsychological measures are reported. We conclude that BPCT may be a viable intervention for TBI outpatients as an adjunct to comprehensive neurorehabilitation. The intervention can be delivered in patients' homes with support provided remotely. Results of this study demonstrate the potential for treatment-related improvements many years after injury. Further study in controlled trials is warranted.
Outcomes from a pilot study using computer-based rehabilitative tools in a military population. [2018]Novel therapeutic approaches and outcome data are needed for cognitive rehabilitation for patients with a traumatic brain injury; computer-based programs may play a critical role in filling existing knowledge gaps. Brain-fitness computer programs can complement existing therapies, maximize neuroplasticity, provide treatment beyond the clinic, and deliver objective efficacy data. However, these approaches have not been extensively studied in the military and traumatic brain injury population. Walter Reed National Military Medical Center established its Brain Fitness Center (BFC) in 2008 as an adjunct to traditional cognitive therapies for wounded warriors. The BFC offers commercially available "brain-training" products for military Service Members to use in a supportive, structured environment. Over 250 Service Members have utilized this therapeutic intervention. Each patient receives subjective assessments pre and post BFC participation including the Mayo-Portland Adaptability Inventory-4 (MPAI-4), the Neurobehavioral Symptom Inventory (NBSI), and the Satisfaction with Life Scale (SWLS). A review of the first 29 BFC participants, who finished initial and repeat measures, was completed to determine the effectiveness of the BFC program. Two of the three questionnaires of self-reported symptom change completed before and after participation in the BFC revealed a statistically significant reduction in symptom severity based on MPAI and NBSI total scores (p < .05). There were no significant differences in the SWLS score. Despite the typical limitations of a retrospective chart review, such as variation in treatment procedures, preliminary results reveal a trend towards improved self-reported cognitive and functional symptoms.
Improving cognitive function after brain injury: the use of exercise and virtual reality. [2022]To assess the impact of exercise and virtual reality (VR) on the cognitive rehabilitation of persons with traumatic brain injury (TBI).
Use of a randomized clinical trial design to study cognitive rehabilitation approaches to enhance warfighter performance. [2020]Within the military, cognitive readiness is essential to ensure the warfighter can return to highly demanding combat training and deployment operations. The warfighter must be able to make split second decisions and adapt to new tools and environments. After a traumatic brain injury, clinicians helping the warfighter must have techniques that address warfighter cognitive readiness. Current rehabilitation for cognitive complaints used in military medicine are modeled after civilian therapies which focus on remediating moderate to severe impairment through building compensatory strategies. This traditional approach to cognitive rehabilitation does not translate well to mild traumatic brain injury (mTBI) where impairments are subtle, nor does it meet the needs of our warfighters in deployed and combat training environments. Challenging our current methods is critical in adapting to the needs of this highly valued population to ensure that our warfighters are able to carry out mission critical decision making. Here we present a review of our best current practices for cognitive rehabilitation, describe the limitations our traditional approaches impose for mTBI in military personnel, and present an alternative treatment called Strategic Memory Advanced Reasoning Training (SMART) that can be adopted through a randomized clinical trial design. We propose directly comparing traditional treatment approaches with a novel cognitive rehabilitation strategy which has been well validated outside of the military setting. Procedures were developed to execute this clinical trial in a way that is most relevant to the study population by establishing ecologically valid outcome metrics.
Cognitive Training for Post-Acute Traumatic Brain Injury: A Systematic Review and Meta-Analysis. [2020]Objective: To quantitatively aggregate effects of cognitive training (CT) on cognitive and functional outcome measures in patients with traumatic brain injury (TBI) more than 12-months post-injury. Design: We systematically searched six databases for non-randomized and randomized controlled trials of CT in TBI patients at least 12-months post-injury reporting cognitive and/or functional outcomes. Main Measures: Efficacy was measured as standardized mean difference (Hedges' g) of post-training change. We investigated heterogeneity across studies using subgroup analyses and meta-regressions. Results: Fourteen studies encompassing 575 patients were included. The effect of CT on overall cognition was small and statistically significant (g = 0.22, 95%CI 0.05 to 0.38; p = 0.01), with low heterogeneity (I2 = 11.71%) and no evidence of publication bias. A moderate effect size was found for overall functional outcomes (g = 0.32, 95%CI 0.08 to 0.57, p = 0.01) with low heterogeneity (I2 = 14.27%) and possible publication bias. Statistically significant effects were also found only for executive function (g = 0.20, 95%CI 0.02 to 0.39, p = 0.03) and verbal memory (g = 0.32, 95%CI 0.14 to 0.50, p < 0.01). Conclusion: Despite limited studies in this field, this meta-analysis indicates that CT is modestly effective in improving cognitive and functional outcomes in patients with post-acute TBI and should therefore play a more significant role in TBI rehabilitation.
A Protocol for Remote Cognitive Training Developed for Use in Clinical Populations During the COVID-19 Pandemic. [2023]Many traumatic brain injury (TBI) survivors face scheduling and transportation challenges when seeking therapeutic interventions. The COVID-19 pandemic created a shift in the use of at-home spaces for work, play, and research, inspiring the development of online therapeutic options. In the current study, we determined the feasibility of an at-home cognitive training tool (NeuroTrackerX) that uses anaglyph three-dimensional (3D) glasses and three-dimensional multiple object tracking (3D-MOT) software. We recruited 20 adults (10 female; mean age = 68.3 years, standard deviation [SD] = 6.75) as the at-home training group. We assessed cognitive health status for participants using a self-report questionnaire and the Mini-Mental State Examination (MMSE), and all participants were deemed cognitively healthy (MMSE >26). At-home participants loaned the necessary equipment (e.g., 3D glasses, computer equipment) from the research facilities and engaged in 10 training sessions over 5 weeks (two times per week). Participant recruitment, retention, adherence, and experience were used as markers of feasibility. For program validation, 20 participants (10 female; mean age = 63.39 years, SD = 12.22), who had previously completed at least eight sessions of the in-lab 3D-MOT program, were randomly selected as the control group. We assessed individual session scores, overall improvement, and learning rates between groups. Program feasibility is supported by high recruitment and retention, 90% participant adherence, and participants' ease of use of the program. Validation of the program is supported. Groups showed no differences in session scores (p > 0.05) and percentage improvement (p > 0.05) despite the differences in screen size and 3D technology. Participants in both groups showed significant improvements in task performance across the training sessions (p < 0.001). NeuroTrackerX provides a promising at-home option for cognitive training in cognitively healthy adults and may be a promising avenue as an at-home therapeutic for TBI survivors. This abstract was previously published on clinicaltrials.gov and can be found at: https://www.clinicaltrials.gov/ct2/show/NCT05278273.
Returning service members to duty following mild traumatic brain injury: exploring the use of dual-task and multitask assessment methods. [2022]Within the last decade, more than 220,000 service members have sustained traumatic brain injury (TBI) in support of military operations in Iraq and Afghanistan. Mild TBI may result in subtle cognitive and sensorimotor deficits that adversely affect warfighter performance, creating significant challenges for service members, commanders, and clinicians. In recent conflicts, physical therapists and occupational therapists have played an important role in evaluating service member readiness to return to duty (RTD), incorporating research and best practices from the sports concussion literature. Because premorbid (baseline) performance metrics are not typically available for deployed service members as for athletes, clinicians commonly determine duty readiness based upon the absence of postconcussive symptoms and return to "normal" performance on clinical assessments not yet validated in the military population. Although practices described in the sports concussion literature guide "return-to-play" determinations, resolution of symptoms or improvement of isolated impairments may be inadequate to predict readiness in a military operational environment. Existing clinical metrics informing RTD decision making are limited because they fail to emphasize functional, warrior task demands and they lack versatility to assess the effects of comorbid deficits. Recently, a number of complex task-oriented RTD approaches have emerged from Department of Defense laboratory and clinical settings to address this gap. Immersive virtual reality environments, field-based scenario-driven assessment programs, and militarized dual-task and multitask-based approaches have all been proposed for the evaluation of sensorimotor and cognitive function following TBI. There remains a need for clinically feasible assessment methods that can be used to verify functional performance and operational competence in a variety of practice settings. Complex and ecologically valid assessment techniques incorporating dual-task and multitask methods may prove useful in validating return-to-activity requirements in civilian and military populations.
Driving rehabilitation for military personnel recovering from traumatic brain injury using virtual reality driving simulation: a feasibility study. [2021]To investigate the feasibility of virtual reality driving simulation rehabilitation training (VRDSRT) with military personnel recovering from traumatic brain injury (TBI).