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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Plasticity in Brain Network to Enhance Cognitive Rehabilitation

Conditions
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Brain Injury

Intervention / Treatment
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* Behavioral: training in goal-directed attention regulation
* Behavioral: brain health education
* Behavioral: computer-assisted training in goal-directed attention regulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Goal-oriented Attention Regulation Training<br>training in goal-directed attention regulation | Behavioral: training in goal-directed attention regulation<br>* training in goal-directed attention regulation<br>|
| Active Comparator: Education<br>brain health education | Behavioral: brain health education<br>* brain health education workshops<br>|
| Experimental: Technology-assisted Goal-directed Self-Regulation Training<br>computer-assisted training in goal-directed attention regulation | Behavioral: computer-assisted training in goal-directed attention regulation<br>* computer-assisted training in goal-directed attention regulation, with trainer guidance and cognitive games to practice skills<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Post-training for Task Errors on a Functional Performance Measure | 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). | 5 weeks (After completion of Arm 1 and Arm 2) | 
| Change to Attention and Executive Functioning Composite Scores | 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. | 5 weeks (After completion of Arm 1 and Arm 2) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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attention, rehabilitation, training, functional MRI, executive function, brain injury