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Executive Function Training Intervention for Chronic Traumatic Brain Injury

Primary Purpose

Traumatic Brain Injury

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Expedition

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring chronic traumatic brain injury, cognition, executive function

Eligibility Criteria

19 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The University of Texas at Dallas Center for BrainHealth

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Expedition: Strategic Advantage

Expedition: Informational Advantage

Arm Description

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.

Outcomes

Primary Outcome Measures

Virtual Multiple Errands Test

executive function measure carried out in computer simulation of shopping market

Secondary Outcome Measures

Resting-State functional Magnetic Resonance Imaging (fMRI)

functional connectivity assessment

Task-based functional Magnetic Resonance Imaging (fMRI)

functional brain imaging attention task

Automated Neuropsychological Assessement Metrics (ANAM)

code substitution, go/no go, logical relations, manikin, match-to-sample, Mathematical processing

Traumatic Brain Injury (TBI) Awareness Questionnaire

Survey measure asking for estimate of current symptoms compared to before brain injury

Full Information

NCT ID

NCT03704116

First Posted

July 3, 2018

Last Updated

March 29, 2021

Sponsor

The University of Texas at Dallas

Collaborators

Applied Research Associates, Inc

1. Study Identification

Unique Protocol Identification Number

NCT03704116

Brief Title

Executive Function Training Intervention for Chronic Traumatic Brain Injury

Official Title

Project Expedition: Executive Function Training Intervention for Chronic Traumatic Brain Injury

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

July 16, 2018 (Actual)

Primary Completion Date

February 1, 2021 (Actual)

Study Completion Date

February 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas at Dallas

Collaborators

Applied Research Associates, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Traumatic Brain Injury

Keywords

chronic traumatic brain injury, cognition, executive function

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Two groups run in parallel (active and control)

Masking

ParticipantOutcomes Assessor

Masking Description

Double-blinded

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Expedition: Strategic Advantage

Arm Type

Active Comparator

Arm Description

Arm Title

Expedition: Informational Advantage

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Expedition

Intervention Description

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.

Primary Outcome Measure Information:

Title

Virtual Multiple Errands Test

Description

executive function measure carried out in computer simulation of shopping market

Time Frame

change is evaluated from the beginning of the intervention to after completion (1 month in between)

Secondary Outcome Measure Information:

Title

Resting-State functional Magnetic Resonance Imaging (fMRI)

Description

functional connectivity assessment

Time Frame

change is evaluated from the beginning of the intervention to after completion (1 month in between)

Title

Task-based functional Magnetic Resonance Imaging (fMRI)

Description

functional brain imaging attention task

Time Frame

change is evaluated from the beginning of the intervention to after completion (1 month in between)

Title

Automated Neuropsychological Assessement Metrics (ANAM)

Description

code substitution, go/no go, logical relations, manikin, match-to-sample, Mathematical processing

Time Frame

change is evaluated from the beginning of the intervention to after completion (1 month in between)

Title

Traumatic Brain Injury (TBI) Awareness Questionnaire

Description

Survey measure asking for estimate of current symptoms compared to before brain injury

Time Frame

change is evaluated from the beginning of the intervention to after completion (1 month in between)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

The University of Texas at Dallas Center for BrainHealth

City

Dallas

State/Province

Texas

ZIP/Postal Code

75235

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31307502

Citation

Krawczyk DC, Han K, Martinez D, Rakic J, Kmiecik MJ, Chang Z, Nguyen L, Lundie M, Cole RC, Nagele M, Didehbani N. Executive function training in chronic traumatic brain injury patients: study protocol. Trials. 2019 Jul 15;20(1):435. doi: 10.1186/s13063-019-3526-x.

Results Reference

derived

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Executive Function Training Intervention for Chronic Traumatic Brain Injury

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