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

NCT ID: NCT01035606

Last Updated: 2017-10-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2017-04-30

Brief Summary

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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

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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.

Conditions

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Brain Injury

Keywords

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attention rehabilitation training functional MRI executive function brain injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Goal-oriented Attention Regulation Training

training in goal-directed attention regulation

Group Type EXPERIMENTAL

training in goal-directed attention regulation

Intervention Type BEHAVIORAL

training in goal-directed attention regulation

Education

brain health education

Group Type ACTIVE_COMPARATOR

brain health education

Intervention Type BEHAVIORAL

brain health education workshops

Technology-assisted Goal-directed Self-Regulation Training

computer-assisted training in goal-directed attention regulation

Group Type EXPERIMENTAL

computer-assisted training in goal-directed attention regulation

Intervention Type BEHAVIORAL

computer-assisted training in goal-directed attention regulation, with trainer guidance and cognitive games to practice skills

Interventions

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training in goal-directed attention regulation

training in goal-directed attention regulation

Intervention Type BEHAVIORAL

brain health education

brain health education workshops

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role collaborator

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark D'Esposito, MD

Role: PRINCIPAL_INVESTIGATOR

VA Northern California Health Care System, Mather, CA

Locations

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VA Northern California Health Care System, Mather, CA

Sacramento, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 21169860 (View on PubMed)

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.

Reference Type RESULT
PMID: 21515904 (View on PubMed)

Related Links

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http://www.ncire.org

Northern California Institute for Research and Education

Other Identifiers

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B4605-I

Identifier Type: -

Identifier Source: org_study_id