PC-Based Cognitive Rehabilitation for Traumatic Brain Injury (TBI)
The investigators will evaluate whether it is possible to improve memory and attention in patients who have suffered traumatic brain injury through the use of at-home computer training. Patients will be issued a computer and will train for three months on tasks that become more challenging as the subjects performance improves. The investigators will evaluate whether the training strengthened mental abilities in general, but evaluating mental abilities in the laboratory before and after testing.
Traumatic Brain Injury
Behavioral: Memory training
Behavioral: Executive function training
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||PC-Based Cognitive Rehabilitation for TBI|
- Change in performance on standardized neuropsychological tests [ Time Frame: Tested immediately before and after training, with retention assessed at 6 mo ] [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Behavioral: Memory training
Training of visuospatial and verbal memoryBehavioral: Executive function training
Training of executive control functions
Here we propose two randomized clinical trials to determine if at-home PC-based adaptive training can improve cognitive function in chronic TBI patients. Both trials will use protocols designed to drive beneficial neuroplastic changes using paradigms similar to those that have shown promising results in smaller scale studies. The first experiment will investigate the effects of training of short-term verbal and spatial memory. 36 patients with chronic mild, moderate and severe TBI will be evaluated with an extensive battery of neuropsychological tests (NPTs) and subjective rating scale measures at study entry. NPT and rating scale data will be compared to those obtained from 100 matched control subjects to characterize the cognitive deficits following mild, moderate and severe TBI. Patients will then be randomly assigned to immediate training (IT) or delayed training (DT) groups in a longitudinal crossover design. IT patients will begin training for 20 min/day on each of three different memory tasks for a period of three months. Training data will be automatically uploaded to monitor daily compliance and learning rate. NPT and rating scale assessments will be obtained midway through the study. Comparisons of changes in trained (IT) and untrained (DT) groups will be used to evaluate training efficacy. Then, during the second phase of the study, the DT group will undergo identical training. Repeat testing at the end of the study will quantify the effects of training on the DT group, and evaluate retention of training benefit in the IT group.
The second experiment will evaluate the effects of training on attention and executive function using a similar randomized trial with a separate group of 36 chronic TBI patents. A comparison of the magnitude of training-related improvements in the two experiments will be used to evaluate specific- and non-specific factors that contribute to training benefit and identify the patient characteristics that are most critical for successful cognitive rehabilitation.
|United States, California|
|VA Northern California HCS|
|Martinez, California, United States, 94553|
|Principal Investigator:||David L. Woods, PhD||VA Northern California HCS|