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

Plasticity in Brain Network to Enhance Cognitive Rehabilitation

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.

Study Overview

• Status: Completed
• Conditions: Brain Injury
• Intervention / Treatment: Behavioral: training in goal-directed attention regulation; Behavioral: brain health education; Behavioral: computer-assisted training in goal-directed attention regulation

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 Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95655
      • VA Northern California Health Care System, Mather, CA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-report	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.	5 Weeks (After completion of active trainings in Arm 1 and Arm 3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to Post-training for Task Errors on a Functional Performance Measure	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).	5 weeks (After completion of Arm 1 and Arm 2)
Change to Attention and Executive Functioning Composite Scores	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.	5 weeks (After completion of Arm 1 and Arm 2)

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: University of California, San Francisco
• Investigators: Principal Investigator: Mark D'Esposito, MD, VA Northern California Health Care System, Mather, CA

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Northern California Institute for Research and Education

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: December 16, 2009
• First Submitted That Met QC Criteria: December 16, 2009
• First Posted (Estimate): December 18, 2009

Study Record Updates

• Last Update Posted (Actual): October 20, 2017
• Last Update Submitted That Met QC Criteria: October 18, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: rehabilitation; functional MRI; brain injury; training; executive function; attention
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries
• Other Study ID Numbers: B4605-I