Clinical trial NCT01035606: Training in Goal-directed Attention Regulation for Individuals With Brain Injury
Official title: Plasticity in Brain Network to Enhance Cognitive Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injury
Keywords: attention
rehabilitation
training
functional MRI
executive function
brain injury
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: University of California, San Francisco
First posted: 2009-12-18
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Self-report
timeFrame: 5 Weeks (After completion of active trainings in Arm 1 and Arm 3)
Secondary outcomes:
measure: Change From Baseline to Post-training for Task Errors on a Functional Performance Measure
timeFrame: 5 weeks (After completion of Arm 1 and Arm 2)
measure: Change to Attention and Executive Functioning Composite Scores
timeFrame: 5 weeks (After completion of Arm 1 and Arm 2)
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: VA Northern California Health Care System, Mather, CA
state: California
Study officials:
affiliation: VA Northern California Health Care System, Mather, CA
name: Mark D'Esposito, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.