Traumatic Brain InjuryNCT03704116
Executive Function Training Intervention for Chronic Traumatic Brain Injury
A study testing Expedition in people with Traumatic Brain Injury, run by The University of Texas at Dallas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 55 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Expedition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2018to 1 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas at Dallas Center for BrainHealth
Dallas, Texas, 75235
About this study
Official title: Project Expedition: Executive Function Training Intervention for Chronic Traumatic Brain Injury
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.
Read the 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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Expedition
- Keywords
- chronic traumatic brain injury, cognition, executive function
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExpeditionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Expedition: Strategic Advantage | Active comparator | 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. Receives: Behavioral: Expedition |
| Expedition: Informational Advantage | Placebo comparator | 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. Receives: Behavioral: Expedition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virtual Multiple Errands Test
executive function measure carried out in computer simulation of shopping market
Measured: change is evaluated from the beginning of the intervention to after completion (1 month in between)
Secondary outcomes (4)
Resting-State functional Magnetic Resonance Imaging (fMRI)
functional connectivity assessment
Measured: change is evaluated from the beginning of the intervention to after completion (1 month in between)
Task-based functional Magnetic Resonance Imaging (fMRI)
functional brain imaging attention task
Measured: change is evaluated from the beginning of the intervention to after completion (1 month in between)
Automated Neuropsychological Assessement Metrics (ANAM)
code substitution, go/no go, logical relations, manikin, match-to-sample, Mathematical processing
Measured: change is evaluated from the beginning of the intervention to after completion (1 month in between)
Traumatic Brain Injury (TBI) Awareness Questionnaire
Survey measure asking for estimate of current symptoms compared to before brain injury
Measured: change is evaluated from the beginning of the intervention to after completion (1 month in between)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start16 Jul 2018
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups run in parallel (active and control)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Dallas
- Sponsor type
- University, hospital or other
- Collaborators
- Applied Research Associates, Inc, United States Department of Defense
- Responsible party
- Principal investigator, Dan Krawczyk, The University of Texas at Dallas
- Investigators
- Marcia Clover, Study director, Applied Research Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03704116
- Sponsor's protocol ID
- UTDallas
- Status last verified
- Jun 2024
- First submitted
- 3 Jul 2018
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31307502
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Expedition: Executive Function Training Intervention for Chronic Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT03704116
- Acronym / sponsor ID
- UTDallas
- Conditions
- Traumatic Brain Injury
- Keywords
- chronic traumatic brain injury, cognition, executive function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- The University of Texas at DallasUniversity, hospital or other
- Collaborators
- Applied Research Associates, Inc, United States Department of Defense
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 12 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups run in parallel (active and control)
| Arm | Type | Receives |
|---|---|---|
| Expedition: Strategic Advantage | Active comparator | Behavioral: ExpeditionSoftware-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. |
| Expedition: Informational Advantage | Placebo comparator | Behavioral: ExpeditionSoftware-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. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExpeditionOn 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. | Behavioural | Expedition: Informational Advantage, Expedition: Strategic Advantage |
Primary outcome
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
4 secondary outcomes
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)
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)
Automated Neuropsychological Assessement Metrics (ANAM)
Time frame: change is evaluated from the beginning of the intervention to after completion (1 month in between)
Traumatic Brain Injury (TBI) Awareness Questionnaire
Time frame: change is evaluated from the beginning of the intervention to after completion (1 month in between)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Derived from this study: PubMed 31307502Krawczyk 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcia Clover study director
Applied Research Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expedition in people with Traumatic Brain Injury, run by The University of Texas at Dallas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Virtual Multiple Errands Test (time frame: change is evaluated from the beginning of the intervention to after completion (1 month in between)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03704116, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.