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Published in: Trials 1/2019

Open Access 01-12-2019 | Central Nervous System Trauma | Study protocol

Executive function training in chronic traumatic brain injury patients: study protocol

Authors: Daniel C. Krawczyk, Kihwan Han, David Martinez, Jelena Rakic, Matthew J. Kmiecik, Zhengsi Chang, Linda Nguyen, Michael Lundie, Richard C. Cole, Marielle Nagele, Nyaz Didehbani

Published in: Trials | Issue 1/2019

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Abstract

Background

Some individuals who sustain traumatic brain injuries (TBIs) continue to experience significant cognitive impairments chronically (months to years post injury). Many tests of executive function are insensitive to these executive function impairments, as such impairments may only appear during complex daily life conditions. Daily life often requires us to divide our attention and focus on abstract goals. In the current study, we compare the effects of two 1-month electronic cognitive rehabilitation programs for individuals with chronic TBI. The active program (Expedition: Strategic Advantage) focuses on improving goal-directed executive functions including working memory, planning, long-term memory, and inhibitory control by challenging participants to accomplish life-like cognitive simulations. The challenge level of the simulations increases in accordance with participant achievement. The control intervention (Expedition: Informational Advantage) is identical to the active program; however, the cognitive demand level is capped, preventing participants from advancing beyond a set level. We will evaluate these interventions with a military veteran TBI population.

Methods/design

One hundred individuals will be enrolled in this double-blinded clinical trial (all participants and testers are blinded to condition). Each individual will be randomly assigned to one of two interventions. The primary anticipated outcomes are improvement of daily life cognitive function skills and daily life functions. These are measured by a daily life performance task, which tests cognitive skills, and a survey that evaluates daily life functions. Secondary outcomes are also predicted to include improvements in working memory, attention, planning, and inhibitory control as measured by a neuropsychological test battery. Lastly, neuroimaging measures will be used to evaluate changes in brain networks supporting cognition pre and post intervention.

Discussion

We will test whether electronically delivered cognitive rehabilitation aimed at improving daily life functional skills will provide cognitive and daily life functional improvements for individuals in the chronic phase of TBI recovery (greater than 3 months post injury). We aim to better understand the cognitive processes involved in recovery and the characteristics of individuals most likely to benefit. This study will also address the potential to observe generalizability or to transfer from a software-based cognitive training tool toward daily life improvement.

Trial registration

ClinicalTrials.gov, NCT03704116. Retrospectively registered on 12 Oct 2018.
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Metadata
Title
Executive function training in chronic traumatic brain injury patients: study protocol
Authors
Daniel C. Krawczyk
Kihwan Han
David Martinez
Jelena Rakic
Matthew J. Kmiecik
Zhengsi Chang
Linda Nguyen
Michael Lundie
Richard C. Cole
Marielle Nagele
Nyaz Didehbani
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3526-x

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