Neural Bases of Cognitive Rehabilitation for Brain Injury

Not Applicable

Completed

Conditions: Brain Injury

Interventions: Behavioral: Goal-oriented attentional self-regulation
Behavioral: Brain Health Education

Registration Number: NCT01120756

Lead Sponsor: VA Office of Research and Development

Brief Summary: Some of the most common and disabling consequences of brain injury are deficits in cognition, such as difficulty with sustained attention, memory, organization, and goal management. The long-term goal of this research program is to develop and test novel neuroscience-based cognitive interventions for improving attentional regulation and related "executive function" brain processes involved in goal-directed behavior.

Detailed Description: Brain injury often results in a disruption of attention regulation processes, which reduces the efficiency and effectiveness of cognitive functions including learning, memory, problem-solving and goal management, leading to significant functional disability. More intervention options are needed.

We set out to test different possible interventions. Individuals with traumatic brain injury (TBI) and chronic executive control dysfunction participate in interventions, with pre- and post-intervention measurements of cognitive functioning. Training in Goal-oriented attentional self-regulation (GOALS) was administered in comparison to Brain Health Education (EDU).

GOALS is designed to train attention regulation skills along with meta-cognitive strategies for goal management, with a emphasis on application to participant-selected projects. This is a group-based intervention.

Brain Health Education is designed to increase knowledge and understanding of key factors that affect brain functioning. This is a group-based intervention matched to the GOALS intervention.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 35

Inclusion Criteria

Patients with a history of TBI (reported plausible mechanism of head injury, loss of consciousness with some period of post-traumatic alteration in cognition) who are > 6 months post-injury will be screened for evidence of mild-moderate residual dysfunction in executive control functions based on corroborated reports of real-world difficulties (Mayo-Portland Adaptability Inventory).

Exclusion Criteria

Severely apathetic/abulic
aphasic
or other reasons for patients being unable or unwilling to participate with the training tasks
severe cognitive dysfunction
history of neurodevelopmental abnormalities
ongoing illicit drug or alcohol abuse (AUDIT>8)
severe depression as measured by Beck Depression Inventory (>29)
severe PTSD precluding participation in research activities (such as group training or MRI scanning)
There will be no restriction in regard to gender, race and socioeconomic status.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Goal-oriented attentional self-regulation training	Goal-oriented attentional self-regulation	Goal-oriented attentional self-regulation training (GOALS).
Brain Health Education	Brain Health Education	Brain Health Education (EDU)

Primary Outcome Measures

Name	Time	Method
Change From Baseline on a Composite Measure (Z-score) of Attention, Working Memory, and Executive Functions	Baseline, Within 2-3 weeks Post-intervention	We computed a composite measure based upon the average of individuals' scores on commonly used neuropsychological tests of attention, working memory, and executive functions. To compute this composite score, we first scored individual performances on each neuropsychological measure utilizing published norms, adjusted for, when available, age, gender, ethnicity, and education levels. We then converted all resultant scores (e.g., T-scores, Standard Scores) to a common metric, z-scores. (Z-scores are a standardized unit of measurement, scaled in terms of standard deviation (SD) units. Thus, a z-score of 0 represents the mean; a z-score of 1 represents+1 SD above the mean; and a z-score of -1 represents -1 SD below the mean.) Finally, for each participant, z-scores derived from each separate neuropsychological test were averaged together to yield a final composite score. The composite score was the unit of analysis.

Secondary Outcome Measures

Name	Time	Method
Functional Evaluations: Change From Baseline on the Goal Processing Scale	Baseline, 2-3 Weeks Post-intervention	Observed measures of functional performance on complex tasks were assessed for the GOALS and Brain Health Education study. The overall composite score comprises scores for planning, initiation, self-monitoring, maintenance of attention, sequencing and switching, divergent thinking, execution, learning and memory. Scores range from 1-10. Changes were calculated from pre-to post-training, and higher scores indicate improvement in functioning.