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

Primary Purpose

Traumatic Brain Injury, Impulsivity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Transcranial Direct Current Stimulation (tDCS)
Sham Transcranial Direct Current Stimulation (tDCS)
Sponsored by
Minneapolis Veterans Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Minneapolis VA Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active tDCS

Sham tDCS

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 13, 2019
Last Updated
March 13, 2023
Sponsor
Minneapolis Veterans Affairs Medical Center
Collaborators
Minnesota Office of Higher Education, Center for Veterans Research and Education, The Defense and Veterans Brain Injury Center
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1. Study Identification

Unique Protocol Identification Number
NCT03844607
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 8, 2019 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minneapolis Veterans Affairs Medical Center
Collaborators
Minnesota Office of Higher Education, Center for Veterans Research and Education, The Defense and Veterans Brain Injury Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Impulsivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS
Arm Type
Experimental
Arm Description
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).
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Active Transcranial Direct Current Stimulation (tDCS)
Intervention Description
Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the left frontal cortex for 20 minutes.
Intervention Type
Device
Intervention Name(s)
Sham Transcranial Direct Current Stimulation (tDCS)
Intervention Description
Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning of session).
Primary Outcome Measure Information:
Title
Change in Barratt Impulsiveness Scale (BIS)
Description
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
Secondary Outcome Measure Information:
Title
Change in choice of higher risk option in the Risk Task
Description
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
Title
Change in Brain Functional Connectivity as measured by functional magnetic resonance imaging (fMRI)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Casey S Gilmore, PhD
Phone
612-467-2261
Email
casey.gilmore2@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Kelvin O Lim, MD
Phone
612-725-2000
Ext
3323
Email
kelvin.lim@va.gov
Facility Information:
Facility Name
Minneapolis VA Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Casey S Gilmore, PhD
First Name & Middle Initial & Last Name & Degree
Kelvin O Lim, MD

12. IPD Sharing Statement

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

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