Neural Bases of Cognitive Rehabilitation for Brain Injury
|ClinicalTrials.gov Identifier: NCT01120756|
Recruitment Status : Active, not recruiting
First Posted : May 11, 2010
Last Update Posted : March 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Brain Injury||Behavioral: Goal-oriented attentional self-regulation Behavioral: Pathfinder Attention Process Training Behavioral: Brain Health Education Behavioral: Tonic and Phasic Alertness Training (TAPAT)||Not Applicable|
Brain injury often results in a disruption of attentional regulation processes, which reduces the efficiency and effectiveness of cognitive functions including learning, memory, problem-solving and goal management, leading to significant functional disability. Despite the importance of these problems, few effective interventions are available. Current projects involve developing novel theory-driven neural biomarkers and behavioral measurement tools and training interventions that target attentional control processes. The collection of results will help delineate neural mechanisms that support improved attention regulation that may serve as neurobiological targets for the development of novel interventions that enhance the benefits of rehabilitation.
In a controlled intervention study design, individuals with traumatic brain injury (TBI) and chronic executive control dysfunction will participate in comparison interventions, with pre- and post-intervention measurements of performance on neurocognitive 'challenge' tests assessing targeted and non-targeted domains, functional performance in low structure 'real-world' settings, and functional MRI measurements assessing goal-directed information processing. The interventions are: Goal-oriented attentional self-regulation (GOALS) training, Brain Health Education (EDU), Pathfinder Attention Regulation Training (PATH), and Tonic and Phasic Alertness Training (TAPAT).
GOALS is designed to train attention regulation skills with meta-cognitive strategies for goal management, with application to participant-selected projects.
Brain Health Education is designed to increase knowledge and understanding of key factors that affect brain functioning.
Pathfinder training is designed to intensively train goal-directed self-regulation skills using a combination of digital game scenarios and application to personal life.
TAPAT is designed to improve alertness at two levels: tonic attention of sustained attention and phasic alertness, or the capacity to rapidly and effectively interrupt an ongoing response pattern.
Participants undergo fMRI, neuropsychological and functional assessments at baseline,, after the interventions, and at follow-up.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||210 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Neural Bases of Cognitive Rehabilitation for Brain Injury|
|Actual Study Start Date :||October 1, 2011|
|Actual Primary Completion Date :||September 30, 2017|
|Estimated Study Completion Date :||June 29, 2018|
Experimental: Goal-oriented attentional self-regulation training
Goal-oriented attentional self-regulation training (GOALS).
Behavioral: Goal-oriented attentional self-regulation
This will involve 5-7 weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of home practice). In brief, the GBSM training protocol is designed to maximize the potential for improving attention regulation skills and the goal-directed functions they support, applying mindfulness-based attention regulation training to practice in redirecting attention to goal-relevant processes especially in the context of distractions is emphasized throughout training. Participants are asked to identify realistic functional goals as feasible individual and group projects, and are then trained in goal management strategies on the functional task(s) of their choice.
Experimental: Pathfinder Attention Regulation Training
Pathfinder Attention Regulation Training.
Behavioral: Pathfinder Attention Process Training
Training tools that target goal-directed attention regulation through intensive application and practice with monitored computer-assisted 'real world' simulated scenarios extended into real life situations. Training will last a total of 6-8 weeks, approximately 36 hours of training (12 with in-person trainer interactions, and 24 at home).
Active Comparator: Brain Health Education
Brain Health Education (EDU)
Behavioral: Brain Health Education
Brain Health Education (EDU) will involve 5-7 weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of homework). The EDU intervention involves education in health and brain injury in a classroom format, with study materials for homework.
Experimental: Tonic and Phasic Alertness Training
Tonic and Phasic Alertness Training (TAPAT)
Behavioral: Tonic and Phasic Alertness Training (TAPAT)
The Tonic and Phasic Alertness Training (TAPAT) is designed to improve alertness at two levels: tonic attention of sustained attention and phasic alertness, or the capacity to rapidly and effectively interrupt an ongoing response pattern. Subjects will be presented objects on a computer screen and make speeded responses via button press to non-targeted objects and withhold button press to targeted objects.
- Neuropsychological Tests [ Time Frame: Baseline, Week 5, Week 10, and 6 months ]Measures of attention, working memory, speed of processing, and long-term memory.
- Functional evaluations: Goal Processing Scale and Multiple Errands Test [ Time Frame: Baseline, Week 5, Week 10, and 6 months ]Observed measures of functional performance on complex tasks.
- fMRI [ Time Frame: Baseline, Week 5, Week 10, and 6 months ]Measures of functional brain network parameters and information processing.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01120756
|United States, California|
|Martinez Outpatient Clinic and Community Living Center, Martinez, CA|
|Martinez, California, United States, 94553|
|Principal Investigator:||Anthony J. W. Chen, MD MA||Martinez Outpatient Clinic and Community Living Center, Martinez, CA|