Behavioral changes following a traumatic brain injury (TBI) are one of the biggest challenges for patients, as well as their family members and others involved in their recovery. One of the most common behavioral changes following TBI is the emergence of impulsive behavior, which has been associated with destructive, suicidal, and aggressive behavior, and is related to poor rehabilitation program adherence. The primary objective of this study is to investigate the effect of a novel neuroplasticity based intervention that combines cognitive training and transcranial direct current stimulation (tDCS) to reduce impulsivity and to improve outcomes and quality of life for those who have suffered a TBI.
Behavioral changes following a traumatic brain injury (TBI) are one of the biggest challenges for patients, as well as their family members and others involved in their recovery. One of the most common behavioral changes following TBI is the emergence of impulsive behavior, which has been associated with destructive, suicidal, and aggressive behavior, and is related to poor rehabilitation program adherence. The primary objective of this study is to investigate the effect of a novel neuroplasticity based intervention approach utilizing transcranial direct current stimulation (tDCS) to alter brain neuroplasticity combined with cognitive training tasks selected to functionally target cognition and brain circuits that are impaired in those TBI patients with impulsive behavior. This double-blind, randomized, placebo (sham) controlled study will recruit 30 Veterans with a history of mild, moderate or severe TBI, who exhibit a variety of impulsive behaviors. Participants will be randomly assigned to receive either active or sham tDCS, both paired with cognitive training tasks, once a day for five days. Additionally, participants will attend three follow up visits at 1, 2, and 3 months after the course of intervention visits is completed. Functional magnetic resonance imaging (fMRI) will be collected before and after intervention, to measure brain activity changes across time depending on intervention type.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
33
Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the left frontal cortex for 20 minutes.
Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning of session).
Minneapolis VA Medical Center
Minneapolis, Minnesota, United States
Change in Barratt Impulsiveness Scale (BIS)
Differences in magnitude of change in BIS scores between active tDCS and sham groups from baseline to follow-up sessions. Higher total score on the BIS indicates higher levels of impulsivity.
Time frame: Change between baseline and 1 week follow-up; 1, 2, and 3 months following intervention
Change in choice of higher risk option in the Risk Task
Differences in magnitude of change in choice of higher risk option during the Risk Task between active tDCS and sham groups from baseline to follow-up sessions. Greater choice of higher risk options in the Risk Task indicates higher levels of risk-taking and impulsivity.
Time frame: Change between baseline and 1 week follow-up; 1, 2, and 3 months following intervention
Change in Brain Functional Connectivity as measured by functional magnetic resonance imaging (fMRI)
Compare magnitude of change in frontal-striatal functional connectivity between active tDCS and sham groups from baseline to following the 5 sessions of intervention.
Time frame: Change between baseline and 1 week follow-up
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