Neural Bases of Cognitive Rehabilitation for Brain Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Department of Veterans Affairs
Sponsor:
Collaborator:
University of California, Berkeley
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01120756
First received: May 7, 2010
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

Some of the most common and disabling consequences of brain injury are deficits in cognition, such as difficulty with sustained attention, memory, organization, and goal management. The long-term goal of this research program is to develop and test novel neuroscience-based cognitive assessment tools and interventions for improving attentional regulation and related "executive function" brain processes involved in goal-directed behavior.


Condition Intervention
Brain Injury
Behavioral: Goal-based Self Management
Behavioral: Brain Health Education
Behavioral: Pathfinder Attention Process Training
Behavioral: Brain Health Education with Motor Skills Training (EDU/MOTOR)
Behavioral: Tonic and Phasic Alertness Training (TAPAT)
Behavioral: Object Discrimination Training (ODT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neural Bases of Cognitive Rehabilitation for Brain Injury

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Neuropsychological Tests [ Time Frame: Baseline, Week 5, Week 10, and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional evaluations: Goal Processing Scale and Multiple Errands Test [ Time Frame: Baseline, Week 5, Week 10, and 6 months ] [ Designated as safety issue: No ]
  • fMRI [ Time Frame: Baseline, Week 5, Week 10, and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 210
Study Start Date: October 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Goal-based Self Management training (GBSM) will involve 5-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). Some subjects will only receive the GBSM intervention.
Behavioral: Goal-based Self Management
Goal-based Self Management (GBSM) will involve 5-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.
Active Comparator: Arm 2
Brain Health Education (EDU) will involve 5-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. Some subjects will start with EDU and then cross-over to the GBSM.
Behavioral: Goal-based Self Management
Goal-based Self Management (GBSM) will involve 5-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.
Behavioral: Brain Health Education
Brain Health Education (EDU) will involve 5-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: Arm 3
Pathfinder Attention Process Training will last between 6-8 weeks, approximately 36 hours of training (12 with in-person trainer interactions, and 24 at home). Some subject will receive the Pathfinder intervention only.
Behavioral: Pathfinder Attention Process Training
We are developing a series of engaging game-based computerized 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 occur in 3 phases, lasting a total of 6-8 weeks, approximately 36 hours of training (12 with in-person trainer interactions, and 24 at home). Patients will start with an on-site training program for 1 week. This phase will focus on goal-directed attention regulation training, including mindfulness-based attentional focus and re-direction. The second phase of training will involve 4-6 weeks of computerized training at home. Participants will complete training 5 days/week. Patients will then return to the study site for therapist-guided training for 1 week.
Active Comparator: Arm 4
Some subjects will start with Brain Health Education (described above) combined with motor speed computer games as homework (EDU/MOTOR). They will then cross over to the Pathfinder intervention.
Behavioral: Pathfinder Attention Process Training
We are developing a series of engaging game-based computerized 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 occur in 3 phases, lasting a total of 6-8 weeks, approximately 36 hours of training (12 with in-person trainer interactions, and 24 at home). Patients will start with an on-site training program for 1 week. This phase will focus on goal-directed attention regulation training, including mindfulness-based attentional focus and re-direction. The second phase of training will involve 4-6 weeks of computerized training at home. Participants will complete training 5 days/week. Patients will then return to the study site for therapist-guided training for 1 week.
Behavioral: Brain Health Education with Motor Skills Training (EDU/MOTOR)
The Brain Health Education classroom training will be the same as described above. The homework will consist of educational DVDs and off-the-shelf computer games that are fun and engaging, requiring simple motor responses but do not engage higher level cognitive processing.
Experimental: Arm 5
Tonic and Phasic Alertness Training (TAPAT) will involve three 12-minute blocks of attention training for a total of 1080 trials over a six-week period.
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.
Active Comparator: Arm 6
Object Discrimination Training (ODT) will involve three 12-minute blocks of object discrimination training for a total of 1080 trials over a six-week period.
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.
Behavioral: Object Discrimination Training (ODT)
Object Discrimination Training (ODT) will use the same stimuli and stimulus delivery parameters as TAPAT but consist of a stimulus discrimination task in which subjects will only be required to discriminate object categories, using a unspeeded, forced-choice format.

Detailed Description:

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 randomized, controlled intervention study design, individuals with traumatic brain injury (TBI) and chronic executive control dysfunction will participate in experimental or comparison interventions matched for time, 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-Based Self Management (GBSM) training, paired with the comparison intervention Brain Health Education (EDU); Pathfinder Attention Process Training (PATH), paired with the comparison intervention Brain Health Education and Motor Skills Training (EDU/MOTOR), and Tonic and Phasic Alertness Training (TAPAT) paired with the comparison intervention Object Discrimination Training (ODT).

Participants assigned to GBSM will start with EDU or GBSM. Assignment will be performed on a pseudo-randomized basis with pairing of individuals in the assignment process to ensure groups are closely matched on age, sex, education level and baseline cognitive status. Post-training assessments occur at week 5. Those who enter with EDU will cross-over to GBSM, while those enter with GBSM will have 5 weeks of only self-driven practice. There is no cross-over from GBSM to EDU in order to better assess potential maintenance effects after GBSM participation as well as reduce overall time commitment for patients and trainers given the time-intensive nature of the EDU intervention. Both groups participate in longitudinal assessments at week 10. Long-term follow-up will be at 6 months.

Subjects assigned to the PATH or EDU/MOTOR interventions will be randomized into one of these two groups. The EDU/MOTOR group will participate in brain health education and motor speed computer games; the PATH group will enter the integrated protocol involving goal-directed attention regulation training with computer-assisted practice. Both groups will participate in Assessment 2 after the first study period. All subjects in the EDU/MOTOR group will be offered entrance to PATH at the completion of the first study period, and this will provide for an additional within-subjects comparison of effects. Subjects will undergo fMRI, neuropsychological and functional assessments at baseline, week 6, week 12 and at 6 months.

Finally, to examine the effectiveness of the TAPAT intervention, subjects will be assigned to either TAPAT or ODT. 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. ODT will use the same stimuli and stimulus delivery parameters as TAPAT but consist of a stimulus discrimination task in which subjects will only be required to discriminate object categories, using a unspeeded, forced-choice format. TAPAT and ODT subjects will undergo fMRI, neuropsychological and functional assessments at baseline, week 6, and week 12.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Patients with a history of TBI (reported plausible mechanism of head injury, loss of consciousness with some period of post-traumatic alteration in cognition) who are > 6 months post-injury will be screened for evidence of mild-moderate residual dysfunction in executive control functions based on corroborated reports of real-world difficulties (Mayo-Portland Adaptability Inventory).

Exclusion Criteria:

  • Severely apathetic/abulic
  • aphasic
  • or other reasons for patients being unable or unwilling to participate with the training tasks
  • severe cognitive dysfunction
  • history of neurodevelopmental abnormalities
  • ongoing illicit drug or alcohol abuse (AUDIT>8)
  • severe depression as measured by Beck Depression Inventory (>29)
  • severe PTSD precluding participation in research activities (such as group training or MRI scanning)
  • There will be no restriction in regard to gender, race and socioeconomic status.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01120756

Contacts
Contact: Deborah C Binder, MA MS BA (510) 527-6034 Deborah.Binder@va.gov
Contact: Anthony Chen, MD MA (415) 750-2011 Anthony.Chen@va.gov

Locations
United States, California
VA Northern California HCS Recruiting
Martinez, California, United States, 94553
Contact: Anthony Chen, MD MA    415-750-2011    Anthony.Chen@va.gov   
Sponsors and Collaborators
University of California, Berkeley
Investigators
Principal Investigator: Mark D'Esposito, MD VA Northern California HCS
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01120756     History of Changes
Other Study ID Numbers: B7467-I
Study First Received: May 7, 2010
Last Updated: April 2, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
executive dysfunction
brain injury
attention
rehabilitation
fMRI

Additional relevant MeSH terms:
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on August 18, 2014