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Executive Function Training Intervention for Chronic Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT03704116
Recruitment Status : Completed
First Posted : October 12, 2018
Last Update Posted : April 1, 2021
Sponsor:
Collaborator:
Applied Research Associates, Inc
Information provided by (Responsible Party):
Dan Krawczyk, The University of Texas at Dallas

Study Description
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Brief Summary:

Traumatic Brain Injury (TBI) is a prevalent disorder developed by military personnel. While some individuals recover function within months after injury, others continue to suffer from cognitive problems months to years later and may not become evident immediately, particularly for the recently transitioned veteran. Chronic TBI cases may include persistent difficulties in cognition that negatively impact employment and personal relationships.

The investigators will test and evaluate software-based interventions aimed at improving cognition in veterans experiencing everyday life cognitive deficits due to TBI. The interventions will be administered on a computer using a tele-health approach. Two conditions will be compared, an active condition challenging memory, inhibitory control and planning, and a context-matched control condition that is lower on these challenge levels.


Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Behavioral: Expedition Not Applicable

Detailed Description:

The investigators will evaluate the improvement of chronic TBI symptoms after interventions. The investigators will evaluate the improvement of chronic mTBI symptoms using Magnetic Resonance Imaging (MRI)-based injury markers, cognitive functions, and real-world functioning questionnaires.

The investigators will recruit military veterans with mild-to-moderate chronic TBI (at least 3 months post injury). The investigators will gather neuropsychological, cognitive, and neuroimaging (functional MRI, resting-state functional MRI) measures. The efficacy of the active compared to control intervention will be evaluated in 100 chronic TBI veterans. All participants will be randomized to a group to complete four weeks of intervention over 20 performance sessions. Over the course of training participants will face escalating challenges in each of these domains, thereby improving their overall skills. The software captures response times and accuracy of performance throughout each task. Evaluations of cognition (neuropsychological testing), brain (MRI), real life functional ability (survey data), and real life performance data (multiple errands tasks) will be gathered pre- and post-intervention to evaluate cognitive, brain-based, and real life functional improvements.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two groups run in parallel (active and control)
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Double-blinded
Primary Purpose: Treatment
Official Title: Project Expedition: Executive Function Training Intervention for Chronic Traumatic Brain Injury
Actual Study Start Date : July 16, 2018
Actual Primary Completion Date : February 1, 2021
Actual Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Expedition: Strategic Advantage
Software-based intervention simulating daily life cognitive challenges. Delivered 1 hour per day, 5 days per week for 4 weeks. Includes 8 check-in phone calls with an experimenter. Includes escalating challenge levels.
 Behavioral: Expedition
On a laptop computer participants work on simulated daily life activities including packing for a trip, navigating a transit system, and learning at museum attractions. The intervention increases difficulty as participants accomplish goals. We are testing the effects of this performance challenge on executive function measures.
Placebo Comparator: Expedition: Informational Advantage
Software-based intervention simulating daily life cognitive challenges. Delivered 1 hour per day, 5 days per week for 4 weeks. Includes 8 check-in phone calls with an experimenter. Includes capped challenge levels.
 Behavioral: Expedition
On a laptop computer participants work on simulated daily life activities including packing for a trip, navigating a transit system, and learning at museum attractions. The intervention increases difficulty as participants accomplish goals. We are testing the effects of this performance challenge on executive function measures.


Outcome Measures
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Primary Outcome Measures :
  1. Virtual Multiple Errands Test [ Time Frame: change is evaluated from the beginning of the intervention to after completion (1 month in between) ]
    executive function measure carried out in computer simulation of shopping market


Secondary Outcome Measures :
  1. Resting-State functional Magnetic Resonance Imaging (fMRI) [ Time Frame: change is evaluated from the beginning of the intervention to after completion (1 month in between) ]
    functional connectivity assessment

  2. Task-based functional Magnetic Resonance Imaging (fMRI) [ Time Frame: change is evaluated from the beginning of the intervention to after completion (1 month in between) ]
    functional brain imaging attention task

  3. Automated Neuropsychological Assessement Metrics (ANAM) [ Time Frame: change is evaluated from the beginning of the intervention to after completion (1 month in between) ]
    code substitution, go/no go, logical relations, manikin, match-to-sample, Mathematical processing

  4. Traumatic Brain Injury (TBI) Awareness Questionnaire [ Time Frame: change is evaluated from the beginning of the intervention to after completion (1 month in between) ]
    Survey measure asking for estimate of current symptoms compared to before brain injury


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male and female military veteran adults between the ages of 19 to 55 years (served in the military (any branch))
  • who have sustained a traumatic brain injury at least 3 months previously
  • who can comprehend simple instructions, perform the tests, and take part in the intervention training
  • Selection criteria will also include participants who can safely have an MRI, who can tolerate at least 2 hours of intervention sessions at a time, and who can participate in tasks involving motor abilities such as use of at least one arm and hand
  • No racial/ethnic groups will be excluded, although the patients must be able to speak, read, and comprehend English well enough to participate in the testing and treatment sessions, since the assessments are not normed or translated in other languages at this time.
  • Also, we will screen for possible Post Traumatic Stress Disorder (PTSD) using the Mississippi PTSD Questionnaire, but it will not be an exclusionary criteria.

Exclusion Criteria:

  • someone who is not proficient in reading, comprehending, and speaking English,
  • has pre-existing cerebral palsy, mental retardation, autism, epilepsy, schizophrenia, or pervasive developmental disorder.
  • Individuals with psychosis, active behavioral disorder, or uncontrolled epilepsy will be excluded.
  • Pregnant women will be excluded, since the effects of the treatment or the procedures on a fetus are unknown.
Contacts and Locations
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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): NCT03704116


Locations
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United States, Texas
The University of Texas at Dallas Center for BrainHealth
Dallas, Texas, United States, 75235
Sponsors and Collaborators
The University of Texas at Dallas
Applied Research Associates, Inc
  Study Documents (Full-Text)

Documents provided by Dan Krawczyk, The University of Texas at Dallas:
Study Protocol  [PDF] October 8, 2018
Statistical Analysis Plan  [PDF] October 8, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dan Krawczyk, Professor, Debbie and Jim Francis Chair, The University of Texas at Dallas
ClinicalTrials.gov Identifier: NCT03704116    
Other Study ID Numbers: UTDallas
First Posted: October 12, 2018    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dan Krawczyk, The University of Texas at Dallas:
chronic traumatic brain injury
cognition
executive function
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System