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

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ClinicalTrials.gov Identifier: NCT03844607
Recruitment Status : Recruiting
First Posted : February 18, 2019
Last Update Posted : February 18, 2019
Sponsor:
Collaborators:
Minnesota Office of Higher Education
Center for Veterans Research and Education
The Defense and Veterans Brain Injury Center
Information provided by (Responsible Party):
Casey Gilmore, Minneapolis Veterans Affairs Medical Center

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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Impulsivity Device: Active Transcranial Direct Current Stimulation (tDCS) Device: Sham Transcranial Direct Current Stimulation (tDCS) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combined tDCS and Cognitive Training to Reduce Impulsivity in Patients With Traumatic Brain Injury
Actual Study Start Date : January 8, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active tDCS
Participants will receive 5 sessions of cognitive training concurrent with transcranial direct current stimulation (anode over left frontal cortex, cathode over right frontal cortex; 2 mAmps for 20 minutes).
Device: Active Transcranial Direct Current Stimulation (tDCS)
Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the left frontal cortex for 20 minutes.

Sham Comparator: Sham tDCS
Participants will receive 5 sessions of cognitive training concurrent with sham tDCS. For sham tDCS, electrodes are placed at the same locations as for active tDCS, but current is ramped up for the initial 30 secs, then immediately ramped back down. This method mimics the initial physical sensation of stimulation, but there is no active current for the remainder of the session.
Device: Sham Transcranial Direct Current Stimulation (tDCS)
Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning of session).




Primary Outcome Measures :
  1. Change in Barratt Impulsiveness Scale (BIS) [ Time Frame: 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 Outcome Measures :
  1. Change in choice of higher risk option in the Risk Task [ Time Frame: 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.

  2. Change in Brain Functional Connectivity as measured by functional magnetic resonance imaging (fMRI) [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03844607


Contacts
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Contact: Casey S Gilmore, PhD 612-467-2261 casey.gilmore2@va.gov
Contact: Kelvin O Lim, MD 612-725-2000 ext 3323 kelvin.lim@va.gov

Locations
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United States, Minnesota
Minneapolis VA Medical Center Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Casey S Gilmore, PhD         
Sub-Investigator: Kelvin O Lim, MD         
Sponsors and Collaborators
Minneapolis Veterans Affairs Medical Center
Minnesota Office of Higher Education
Center for Veterans Research and Education
The Defense and Veterans Brain Injury Center

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Responsible Party: Casey Gilmore, Research Scientist, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT03844607     History of Changes
Other Study ID Numbers: VAM-18-00308
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
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Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Impulsive Behavior
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System