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Completed

NCT Number: NCT01035606

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

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Northern California Health Care System, Mather, CA

Sacramento, California, 95655, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

training in goal-directed attention regulation

Behavioral

training in goal-directed attention regulation

Brain Health Education

Behavioral

brain health education workshops

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

Primary outcomes

  1. Self-report

    Time frame: 5 Weeks (After completion of active trainings in Arm 1 and Arm 3)

    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.

Secondary outcomes

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

    Time frame: 5 weeks (After completion of Arm 1 and Arm 2)

    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).

  2. Change to Attention and Executive Functioning Composite Scores

    Time frame: 5 weeks (After completion of Arm 1 and Arm 2)

    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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • University of California, San Francisco

Registry information

Official study title

Plasticity in Brain Network to Enhance Cognitive Rehabilitation

Important dates

Study start
2009
Primary completion
2015
Study completion
2017
First posted
Dec 18, 2009
Registry last updated
Oct 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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