Neural Bases of Cognitive Rehabilitation for Brain Injury
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 35
- Locations
- 2
- Primary Endpoint
- Change From Baseline on a Composite Measure (Z-score) of Attention, Working Memory, and Executive Functions
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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.
Arms & Interventions
Goal-oriented attentional self-regulation training
Goal-oriented attentional self-regulation training (GOALS).
Intervention: Goal-oriented attentional self-regulation (Behavioral)
Brain Health Education
Brain Health Education (EDU)
Intervention: Brain Health Education (Behavioral)
Outcomes
Primary Outcomes
Change From Baseline on a Composite Measure (Z-score) of Attention, Working Memory, and Executive Functions
Time Frame: 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 Outcomes
- Functional Evaluations: Change From Baseline on the Goal Processing Scale(Baseline, 2-3 Weeks Post-intervention)