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

NCT01035606 | Completed Results

• 1 other identifier: B4605-I
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injury

Keywords

attention; rehabilitation; training; functional MRI; executive function; brain injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change From Baseline to Post-training for Task Errors on a Functional Performance Measure

  5 weeks (After completion of Arm 1 and Arm 2)

• Change to Attention and Executive Functioning Composite Scores

  5 weeks (After completion of Arm 1 and Arm 2)

Study Arms (3)

Goal-oriented Attention Regulation Training

EXPERIMENTAL

training in goal-directed attention regulation

Behavioral: training in goal-directed attention regulation

Education

ACTIVE COMPARATOR

brain health education

Behavioral: brain health education

Technology-assisted Goal-directed Self-Regulation Training

EXPERIMENTAL

computer-assisted training in goal-directed attention regulation

Behavioral: computer-assisted training in goal-directed attention regulation

Interventions

training in goal-directed attention regulation BEHAVIORAL

training in goal-directed attention regulation

Goal-oriented Attention Regulation Training

brain health education BEHAVIORAL

brain health education workshops

Education

computer-assisted training in goal-directed attention regulation BEHAVIORAL

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

Technology-assisted Goal-directed Self-Regulation Training

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• history of traumatic brain injury
• greater than 1 week from injury
• residual dysfunction related to attention and executive control

You may not qualify if:

• aphasia
• active illicit drug use
• severe depression
• contraindications to MRI scanning

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of California, San Francisco: collaborator

Study Sites (1)

VA Northern California Health Care System, Mather, CA

Sacramento, California, 95655, United States

Location

Related Publications (2)

• 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.

  PMID: 21169860 BACKGROUND

• 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.

  PMID: 21515904 RESULT

Related Links

• Northern California Institute for Research and Education

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Overall, recruitment challenges resulted in small numbers.

Results Point of Contact

• Title: Anthony Chen, MD
• Organization: VA Northern California

anthony.chen@ucsf.edu

925-372-2000

Study Officials

• Mark D'Esposito, MD

  VA Northern California Health Care System, Mather, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 16, 2009
• First Posted: December 18, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2015
• Study Completion: April 1, 2017
• Last Updated: October 20, 2017
• Results First Posted: October 20, 2017

Record last verified: 2017-10

Locations

US (1)