TY - JOUR
T1 - Executive function training in chronic traumatic brain injury patients
T2 - Study protocol
AU - Krawczyk, Daniel C.
AU - Han, Kihwan
AU - Martinez, David
AU - Rakic, Jelena
AU - Kmiecik, Matthew J.
AU - Chang, Zhengsi
AU - Nguyen, Linda
AU - Lundie, Michael
AU - Cole, Richard C.
AU - Nagele, Marielle
AU - Didehbani, Nyaz
N1 - Funding Information:
This study is funded by the United States Department of Defense (DOD) through the Joint Warfighter Medical Research Program (Award W81XWH-16-1-0053 to DCK). The funding agency has not had a direct role in the design, data collection, analysis, or interpretation of the data for this study, nor have they had a direct role in the preparation of this manuscript or the decision to submit it.
Publisher Copyright:
© 2019 The Author(s).
PY - 2019/7/15
Y1 - 2019/7/15
N2 - 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.
AB - 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.
KW - Attention
KW - Cognitive rehabilitation
KW - Daily life functions
KW - Executive functions
KW - Memory
KW - Planning
KW - Traumatic brain injury
UR - http://www.scopus.com/inward/record.url?scp=85069228749&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85069228749&partnerID=8YFLogxK
U2 - 10.1186/s13063-019-3526-x
DO - 10.1186/s13063-019-3526-x
M3 - Article
C2 - 31307502
AN - SCOPUS:85069228749
SN - 1745-6215
VL - 20
JO - Trials
JF - Trials
IS - 1
M1 - 435
ER -