Clinical trial NCT03844607: Combined tDCS and Cognitive Training to Reduce Impulsivity in Patients With Traumatic Brain Injury
Official title: Combined tDCS and Cognitive Training to Reduce Impulsivity in Patients With Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Impulsivity
Lead sponsor: Minneapolis Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: Minnesota Office of Higher Education
name: Center for Veterans Research and Education
name: The Defense and Veterans Brain Injury Center
First posted: 2019-02-18
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Barratt Impulsiveness Scale (BIS)
timeFrame: Change between baseline and 1 week follow-up; 1, 2, and 3 months following intervention
Secondary outcomes:
measure: Change in choice of higher risk option in the Risk Task
timeFrame: Change between baseline and 1 week follow-up; 1, 2, and 3 months following intervention
measure: Change in Brain Functional Connectivity as measured by functional magnetic resonance imaging (fMRI)
timeFrame: Change between baseline and 1 week follow-up
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis VA Medical Center
state: Minnesota
Study officials:
References: