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Training in Goal-directed Attention Regulation for Individuals With Brain Injury

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01035606
First Posted: December 18, 2009
Last Update Posted: October 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
Brain injuries affect the lives of numerous Veterans. This study examines how the brain is affected by injury and how rehabilitation training for attention dysfunction may change brain functioning.

Condition Intervention
Brain Injury Behavioral: training in goal-directed attention regulation Behavioral: brain health education Behavioral: computer-assisted training in goal-directed attention regulation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The design for Arms 1 and 2 was a cross-over design. Half the participants completed Arm 1 first and then crossed-over to Arm 2; the remaining half completed Arm 2 first and then crossed-over to Arm 1. Thus, all participants completed both Arm 1 and 2.

Arm 3 represented a parallel study. Participants enrolled in this arm did not cross-over to any other condition.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Plasticity in Brain Network to Enhance Cognitive Rehabilitation

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Self-report [ Time Frame: 5 Weeks (After completion of active trainings in Arm 1 and Arm 3) ]
    Responses to goal processing questionnaire relating to areas of personal goal-based functioning. This scale measured participants self-perceived changes to their cognitive and emotional functioning. Participants indicated the degree to which they perceived changes to 11 questions after receiving trainings in Arm 1 and Arm 3 on a 10-point scale (1=domain became worse, 5 = no change, 10 = domain improved). Participants did not complete this measure after Arm 2.


Secondary Outcome Measures:
  • Change From Baseline to Post-training for Task Errors on a Functional Performance Measure [ Time Frame: 5 weeks (After completion of Arm 1 and Arm 2) ]
    Participants completed a functional assessment task, the modified Multiple Errands Task (MET). The MET is an unstructured functional task that permits assessment of participants' abilities to follow outlined rules and complete multiple 'real-world' tasks in a limited time period. Participants were provided written instructions and a map of the hospital where the assessment took place, and were instructed to complete 12 subtasks in 40 minutes while following 9 specified rules. Participants completed this at task at baseline and following Training (Arms 1 & 2, but not 3). Outcome measure was computed as post-training - baseline (negative value reflects less errors made post-training).

  • Change to Attention and Executive Functioning Composite Scores [ Time Frame: 5 weeks (After completion of Arm 1 and Arm 2) ]

    Participants completed the following neuropsychological measures of attention and executive functions before and after Arms 1 and 2, but not Arm 3.

    Letter Number Sequencing from WIAT-III; Auditory Consonant Trigram: 9,18, 36 seconds; Digit Vigilance Test (Time and Errors); DKEFS subtests: Design Fluency, Verbal Fluency Switching, Inhibition (Time and Errors); and Inhibition/Switching (Time and Errors); and Trails B. Performance on these measures were scored based upon age, and when available, educational and repeated administration norms. Resultant scores were transformed into z-scores and aggregated to form a composite measure. Higher z-scores reflect better functioning.

    The unit of analysis for this outcome was the change score from baseline to post-training. Positive change scores reflect improved performance over time[post-training - baseline], whereas negative change scores reflect worsening performance over time.



Enrollment: 49
Study Start Date: September 2009
Study Completion Date: April 2017
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Goal-oriented Attention Regulation Training
training in goal-directed attention regulation
Behavioral: training in goal-directed attention regulation
training in goal-directed attention regulation
Active Comparator: Education
brain health education
Behavioral: brain health education
brain health education workshops
Experimental: Technology-assisted Goal-directed Self-Regulation Training
computer-assisted training in goal-directed attention regulation
Behavioral: computer-assisted training in goal-directed attention regulation
computer-assisted training in goal-directed attention regulation, with trainer guidance and cognitive games to practice skills

Detailed Description:
Traumatic brain injuries (TBI) are a leading cause of long-term disability among combat Veterans. The most common and persistent sequelae after TBI are cognitive-behavioral deficits in 'executive control' and 'attention' functions. Such abnormalities may directly contribute to poor long-term outcomes as well as impede rehabilitation of dysfunction in other cognitive and motor domains. Effective treatments would potentially make a major impact in improving functional outcomes, but consistently effective treatments are not available. The overall goal of this research is to improve the investigators' understanding of plasticity in brain function after TBI and to develop improved cognitive neurorehabilitation treatments. The intervention involves individual and group-based training in cognitive skills.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • history of traumatic brain injury
  • greater than 1 week from injury
  • residual dysfunction related to attention and executive control

Exclusion Criteria:

  • aphasia
  • active illicit drug use
  • severe depression
  • contraindications to MRI scanning
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01035606


Locations
United States, California
VA Northern California Health Care System, Mather, CA
Sacramento, California, United States, 95655
Sponsors and Collaborators
VA Office of Research and Development
University of California, San Francisco
Investigators
Principal Investigator: Mark D'Esposito, MD VA Northern California Health Care System, Mather, CA
  More Information

Additional Information:
Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01035606     History of Changes
Other Study ID Numbers: B4605-I
First Submitted: December 16, 2009
First Posted: December 18, 2009
Results First Submitted: February 27, 2017
Results First Posted: October 20, 2017
Last Update Posted: October 20, 2017
Last Verified: October 2017

Keywords provided by VA Office of Research and Development:
attention
rehabilitation
training
functional MRI
executive function
brain injury

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