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

This study is currently recruiting participants.
Verified January 2013 by Department of Veterans Affairs
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01035606
First received: December 16, 2009
Last updated: January 24, 2013
Last verified: January 2013
History of Changes
  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 Phase
Brain Injury
 Behavioral: training in goal-directed attention regulation
Behavioral: brain health education
Behavioral: computer-assisted training in goal-directed attention regulation
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Plasticity in Brain Network to Enhance Cognitive Rehabilitation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • functional MRI [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • functional performance in real world setting [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
  • performance on neuropsychological testing [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: September 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
training in goal-directed attention regulation
 Behavioral: training in goal-directed attention regulation
training in goal-directed attention regulation
Active Comparator: Arm 2
brain health education
 Behavioral: brain health education
brain health education workshops
Experimental: Arm 3
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 our understanding of plasticity in brain function after TBI and to develop improved cognitive neurorehabilitation treatments.

What specific neural changes support improvements in executive and attention control processes? Advanced functional MRI methods will be used to assay the effects of training interventions designed to improve attention and executive control functioning. The intervention involves individual and group-based training in cognitive skills.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01035606

Contacts
Contact: Anthony Chen, MD MA (415) 750-2011 Anthony.Chen@va.gov
Contact: Deborah C Binder, MA MS BA (510) 527-6034 Deborah.Binder@va.gov

Locations
United States, California
VA Northern California HCS Recruiting
Sacramento, California, United States, 95655
Contact: Deborah C Binder, MA MS BA     510-527-6034     Deborah.Binder@va.gov    
Contact: Anthony Chen, MD MA     (415) 750-2011     Anthony.Chen@va.gov    
Principal Investigator: Mark D'Esposito, MD            
Sponsors and Collaborators
Department of Veterans Affairs
University of California, San Francisco
Investigators
Principal Investigator: Mark D'Esposito, MD VA Northern California HCS
  More Information

Additional Information:
Northern California Institute for Research and Education  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01035606     History of Changes
Other Study ID Numbers: B4605-I
Study First Received: December 16, 2009
Last Updated: January 24, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
attention
rehabilitation
training
 functional MRI
executive function
brain injury

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

ClinicalTrials.gov processed this record on June 18, 2013