Impulsivity, Traumatic Brain Injury
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEActive Transcranial Direct Current Stimulation (tDCS)
Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the left frontal cortex for 20 minutes.
DEVICESham Transcranial Direct Current Stimulation (tDCS)
Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning of session).
Sponsors
Minnesota Office of Higher Education
Center for Veterans Research and Education
The Defense and Veterans Brain Injury Center
Minneapolis Veterans Affairs Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Participants will be included in the study if they: * have a clinical history of impulsive behavior, including substance abuse, gambling problems, legal issues such as DUI, violent acts, aggression, history of suicidality, or ADHD as assessed by the patient's clinical provider and/or screen of medical records * are age 18 or older * are receiving services from the Minneapolis VA Health Care System * are stable on any medications for at least 1 week at the baseline visit * have a diagnosis of mild, moderate, or severe TBI (as defined by VA/DoD Clinical Practice Guidelines criteria)
Exclusion criteria
Persons will be excluded from this study if they: * have a significant neurological disorder based on the Principal Investigators judgment that would impact risk * diagnosed with current active psychosis or mania * have metallic cranial plates/screws or implanted devices * have eczema on scalp or other scalp lesions or skin disorders that may become irritated by stimulation * are pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Barratt Impulsiveness Scale (BIS) | Change between baseline and 1 week follow-up; 1, 2, and 3 months following intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in choice of higher risk option in the Risk Task | Change between baseline and 1 week follow-up; 1, 2, and 3 months following intervention | 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. |
| Change in Brain Functional Connectivity as measured by functional magnetic resonance imaging (fMRI) | Change between baseline and 1 week follow-up | Compare magnitude of change in frontal-striatal functional connectivity between active tDCS and sham groups from baseline to following the 5 sessions of intervention. |
Countries
United States
Outcome results
None listed