This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Neural Bases of Cognitive Rehabilitation for Brain Injury

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of California, Berkeley
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01120756
First received: May 7, 2010
Last updated: August 22, 2017
Last verified: August 2017
  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-oriented attentional self-regulation Behavioral: Pathfinder Attention Process Training Behavioral: Brain Health Education Behavioral: Tonic and Phasic Alertness Training (TAPAT)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (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 VA Office of Research and Development:

Primary Outcome Measures:
  • Neuropsychological Tests [ Time Frame: Baseline, Week 5, Week 10, and 6 months ]
    Measures of attention, working memory, speed of processing, and long-term memory.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 210
Actual Study Start Date: October 1, 2011
Estimated Study Completion Date: September 30, 2017
Estimated Primary Completion Date: September 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Locations
United States, California
Martinez Outpatient Clinic and Community Living Center, Martinez, CA
Martinez, California, United States, 94553
Sponsors and Collaborators
VA Office of Research and Development
University of California, Berkeley
Investigators
Principal Investigator: Anthony Chen, MD MA Martinez Outpatient Clinic and Community Living Center, Martinez, CA
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01120756     History of Changes
Other Study ID Numbers: B7467-I
Study First Received: May 7, 2010
Last Updated: August 22, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
executive dysfunction
brain injury
attention
rehabilitation
fMRI

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

ClinicalTrials.gov processed this record on September 21, 2017