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| Name | Class |
|---|---|
| Applied Research Associates, Inc | UNKNOWN |
| United States Department of Defense | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Expedition | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Virtual Multiple Errands Test | executive function measure carried out in computer simulation of shopping market | change is evaluated from the beginning of the intervention to after completion (1 month in between) |
| Measure | Description | Time Frame |
|---|---|---|
| Resting-State functional Magnetic Resonance Imaging (fMRI) | functional connectivity assessment | change is evaluated from the beginning of the intervention to after completion (1 month in between) |
| Task-based functional Magnetic Resonance Imaging (fMRI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcia Clover | Applied Research Associates | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas at Dallas Center for BrainHealth | Dallas | Texas | 75235 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31307502 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 8, 2018 | Oct 9, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 8, 2018 | Oct 9, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C539497 | CHE protein, Arabidopsis |
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Two groups run in parallel (active and control)
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Double-blinded
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functional brain imaging attention task |
| 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 | 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 | change is evaluated from the beginning of the intervention to after completion (1 month in between) |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |