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History of Changes for Study: NCT03704116
Executive Function Training Intervention for Chronic Traumatic Brain Injury
Latest version (submitted March 29, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 9, 2018 None (earliest Version on record)
2 October 11, 2018 Outcome Measures and Study Status
3 March 29, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT03704116
Submitted Date:  October 9, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: UTDallas
Brief Title: Executive Function Training Intervention for Chronic Traumatic Brain Injury
Official Title: Project Expedition: Executive Function Training Intervention for Chronic Traumatic Brain Injury
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2018
Overall Status: Recruiting
Study Start: July 16, 2018
Primary Completion: May 31, 2020 [Anticipated]
Study Completion: June 30, 2020 [Anticipated]
First Submitted: July 3, 2018
First Submitted that
Met QC Criteria:
October 9, 2018
First Posted: October 12, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
October 9, 2018
Last Update Posted: October 12, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: The University of Texas at Dallas
Responsible Party: Principal Investigator
Investigator: Dan Krawczyk
Official Title: Professor, Debbie and Jim Francis Chair
Affiliation: The University of Texas at Dallas
Collaborators: Applied Research Associates, Inc
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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.

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.

Open or close this module Conditions
Conditions: Traumatic Brain Injury
Keywords: chronic traumatic brain injury
cognition
executive function
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Two groups run in parallel (active and control)
Number of Arms: 2
Masking: Double (Participant, Outcomes Assessor)
Allocation: Randomized
Enrollment: 100 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Open or close this module Outcome Measures
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 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 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. ANAM Automated Neuropsychological Assessement Metrics
[ 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. 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
Open or close this module Eligibility
Minimum Age: 19 Years
Maximum Age: 55 Years
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Central Contact Person: Daniel Krawczyk, PhD
Telephone: 9728833234
Email: daniel.krawczyk@utdallas.edu
Locations: United States, Texas
The University of Texas at Dallas Center for BrainHealth
[Recruiting]
Dallas, Texas, United States, 75235
Contact:Contact: Daniel Krawczyk, PhD 972-883-3234 daniel.krawczyk@utdallas.edu
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Links:
Available IPD/Information:
Open or close this module Document Section
Study Protocol
Document Date: October 8, 2018
Uploaded: 10/09/2018 12:35
File Name: Prot_000.pdf
Statistical Analysis Plan
Document Date: October 8, 2018
Uploaded: 10/09/2018 12:36
File Name: SAP_001.pdf

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