In this randomized, controlled clinical trial, we will evaluate the effects of (1) a brain-training program that uses real-time neurofeedback in functional magnetic resonance imaging (fMRI) to allow people to learn how to gain voluntary control over activity in targeted brain regions and/or (2) 8 weeks of computer-based cognitive training using a software program (Cognitive Remediation for Brain Injury (CRBI)) versus control training tasks on cognitive learning and symptoms. In addition, the investigators will measure brain function (active and resting functional magnetic resonance imaging) and structure (high resolution magnetic resonance imaging) before and after treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
150
Real-time fMRI with neurofeedback.
Computer based attention training.
Control condition for real-time fMRI.
Computer-based games used as a control for the computer based cognitive training intervention.
Carl R Darnall Army Medical Center (CRDAMC)
Fort Hood, Texas, United States
RECRUITINGNeuropsychological assessments
A composite score based on four primary domains (learning, memory, working memory and executive function).
Time frame: 8 weeks
Participant-reported outcomes
A measure of the impact of program use on the participants' own view of their impairment and function
Time frame: 8 weeks
Working/School Status
A measure of participants' employment status, schooling status, and the number of hours worked/volunteered/in school per week
Time frame: 8 weeks
Exercise Based Assessments
Three sets of assessments that are closely modeled on study-related exercises in the auditory, visual, and cognitive control modules, and include auditory speed of processing, visual speed of processing, and cognitive control speed of processing.
Time frame: 4 and 8 weeks
Functional Assessments
Two types of functional measures: a sensitive directly observed performance measure designed originally for normal cognitive aging (timed instrumental activities of daily living, TIADL), and a well-accepted clinical impression measure (the Mayo-Portland Adaptability Inventory, MPAI-4).
Time frame: 8 weeks
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