Combined tDCS and Cognitive Training to Reduce Impulsivity in Patients With Traumatic Brain Injury

  • STATUS
    Recruiting
  • days left to enroll
    6
  • participants needed
    30
  • sponsor
    Minneapolis Veterans Affairs Medical Center
Updated on 9 September 2021
transcranial direct current stimulation
cognitive training
traumatic brain injury
attention deficit hyperactivity disorder

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.

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.

Details
Condition Impulsive Behavior, Impulsivity, Brain Injury, impulsive, traumatic brain injury (tbi), Brain Injuries, Traumatic, Traumatic Brain Injury
Treatment sham transcranial direct current stimulation (tDCS), Active transcranial Direct Current Stimulation (tDCS)
Clinical Study IdentifierNCT03844607
SponsorMinneapolis Veterans Affairs Medical Center
Last Modified on9 September 2021

Eligibility

Yes No Not Sure

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
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