NCT03704116

Executive Function Training Intervention for Chronic Traumatic Brain Injury

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: The University of Texas at Dallas · Academic / Other
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-07-16
• Primary completion: 2021-02-01
• Completion: 2021-02-01
• First posted: 2018-10-12
• Last updated: 2024-06-11

Locations

1 site across 1 country: United States