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

• ClinicalTrials.gov Identifier: NCT01035606
• Recruitment Status: Completed
• First Posted: December 18, 2009
• Results First Posted: October 20, 2017
• Last Update Posted: October 20, 2017
• Sponsor: VA Office of Research and Development
• Collaborator: University of California, San Francisco
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Brain Injury	Behavioral: training in goal-directed attention regulation; Behavioral: brain health education; Behavioral: computer-assisted training in goal-directed attention regulation	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 49 participants
• 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
• Study Start Date: September 2009
• Actual Primary Completion Date: December 2015
• Actual Study Completion Date: April 2017

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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).
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• 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

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:

Northern California Institute for Research and Education 

Publications of Results:

Chen AJ, Novakovic-Agopian T, Nycum TJ, Song S, Turner GR, Hills NK, Rome S, Abrams GM, D'Esposito M. Training of goal-directed attention regulation enhances control over neural processing for individuals with brain injury. Brain. 2011 May;134(Pt 5):1541-54. doi: 10.1093/brain/awr067. Epub 2011 Apr 22.

Other Publications:

Novakovic-Agopian T, Chen AJ, Rome S, Abrams G, Castelli H, Rossi A, McKim R, Hills N, D'Esposito M. Rehabilitation of executive functioning with training in attention regulation applied to individually defined goals: a pilot study bridging theory, assessment, and treatment. J Head Trauma Rehabil. 2011 Sep-Oct;26(5):325-38. doi: 10.1097/HTR.0b013e3181f1ead2.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01035606
• Other Study ID Numbers: B4605-I
• First Posted: December 18, 2009
• 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:

Brain Injuries; Wounds and Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System