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

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
Author Information
  1. Daniel C Krawczyk: Center for BrainHealth, The University of Texas at Dallas, 2200 Mockingbird Lane, Dallas, TX, 75235, USA. daniel.krawczyk@utdallas.edu. ORCID
  2. Kihwan Han: Center for BrainHealth, The University of Texas at Dallas, 2200 Mockingbird Lane, Dallas, TX, 75235, USA.
  3. David Martinez: Center for BrainHealth, The University of Texas at Dallas, 2200 Mockingbird Lane, Dallas, TX, 75235, USA.
  4. Jelena Rakic: Center for BrainHealth, The University of Texas at Dallas, 2200 Mockingbird Lane, Dallas, TX, 75235, USA.
  5. Matthew J Kmiecik: Center for BrainHealth, The University of Texas at Dallas, 2200 Mockingbird Lane, Dallas, TX, 75235, USA.
  6. Zhengsi Chang: Center for BrainHealth, The University of Texas at Dallas, 2200 Mockingbird Lane, Dallas, TX, 75235, USA.
  7. Linda Nguyen: Center for BrainHealth, The University of Texas at Dallas, 2200 Mockingbird Lane, Dallas, TX, 75235, USA.
  8. Michael Lundie: Center for BrainHealth, The University of Texas at Dallas, 2200 Mockingbird Lane, Dallas, TX, 75235, USA.
  9. Richard C Cole: Center for BrainHealth, The University of Texas at Dallas, 2200 Mockingbird Lane, Dallas, TX, 75235, USA.
  10. Marielle Nagele: Center for BrainHealth, The University of Texas at Dallas, 2200 Mockingbird Lane, Dallas, TX, 75235, USA.
  11. Nyaz Didehbani: Department of Psychiatry, University of Texas Southwestern Medical Center at Dallas, NE 210, 5323 Harry Hines Blvd., Dallas, TX, 75390, USA.

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.

Keywords

Associated Data

ClinicalTrials.gov | NCT03704116

References

  1. Nurs Times. 1975 Jun 12;71(24):914-7 [PMID: 1134975]
  2. Clin Neuropsychol. 2001 Dec;15(4):498-507 [PMID: 11935451]
  3. J Head Trauma Rehabil. 2005 Jan-Feb;20(1):76-94 [PMID: 15668572]
  4. J Cogn Neurosci. 2005 Mar;17(3):507-17 [PMID: 15814009]
  5. J Head Trauma Rehabil. 2003 Jul-Aug;18(4):307-16 [PMID: 16222127]
  6. J Int Neuropsychol Soc. 2006 Mar;12(2):194-209 [PMID: 16573854]
  7. J Head Trauma Rehabil. 2007 Nov-Dec;22(6):318-29 [PMID: 18025964]
  8. N Engl J Med. 2008 Jan 31;358(5):453-63 [PMID: 18234750]
  9. Addiction. 2008 Jun;103(6):1039-47 [PMID: 18373724]
  10. N Engl J Med. 2009 Apr 16;360(16):1588-91 [PMID: 19369664]
  11. Neuroimage. 2010 Sep;52(3):1059-69 [PMID: 19819337]
  12. Dev Sci. 2009 Nov;12(6):978-90 [PMID: 19840052]
  13. Brain. 1991 Apr;114 ( Pt 2):727-41 [PMID: 2043945]
  14. Arch Phys Med Rehabil. 1991 Jun;72(7):460-4 [PMID: 2059116]
  15. Trials. 2013 Jan 30;14:29 [PMID: 23363480]
  16. Front Behav Neurosci. 2014 Dec 05;8:405 [PMID: 25538578]
  17. Neuropsychol Rehabil. 2016 Aug;26(4):502-31 [PMID: 26018041]
  18. J Int Neuropsychol Soc. 2016 Feb;22(2):263-79 [PMID: 26888622]
  19. Clin Neuropsychol. 2016 May;30(4):547-57 [PMID: 27187762]
  20. J Trauma. 1988 Dec;28(12):1637-43 [PMID: 3199464]
  21. J Neurol Neurosurg Psychiatry. 1981 Apr;44(4):285-93 [PMID: 6453957]
  22. Behav Res Ther. 1996 Aug;34(8):669-73 [PMID: 8870294]
  23. Brain Inj. 1998 Jan;12(1):63-8 [PMID: 9483338]
  24. Arch Intern Med. 1998 Sep 14;158(16):1789-95 [PMID: 9738608]

Grants

  1. W81XWH-16-1-0053/Congressionally Directed Medical Research Programs

MeSH Term

Activities of Daily Living
Adolescent
Adult
Attention
Brain
Brain Injuries, Traumatic
Cognition
Cognitive Behavioral Therapy
Double-Blind Method
Executive Function
Female
Humans
Male
Memory
Middle Aged
Randomized Controlled Trials as Topic
Texas
Time Factors
Treatment Outcome
Veterans Health
Video Games
Young Adult

Word Cloud

Created with Highcharts 10.0.0cognitivelifedailywillindividualsfunctionsbraininjuryfunctionimpairmentspostexecutivestudyrehabilitationchronicTBImemorycontrolparticipantslevelskillstraumaticmonthstestsDailyattentiontwoactiveprogramExpedition:AdvantageimprovingworkingplanninginhibitorysimulationsinterventionevaluateinterventionsoutcomesimprovementmeasuredalsoimprovementstestfunctionalrecoverytrainingExecutiveBACKGROUND:sustaininjuriesTBIscontinueexperiencesignificantchronicallyyearsManyinsensitivemayappearcomplexconditionsoftenrequiresusdividefocusabstractgoalscurrentcompareeffects1-monthelectronicprogramsStrategicfocusesgoal-directedincludinglong-termchallengingaccomplishlife-likechallengeincreasesaccordanceparticipantachievementInformationalidenticalhoweverdemandcappedpreventingadvancingbeyondsetmilitaryveteranpopulationMETHODS/DESIGN:Onehundredenrolleddouble-blindedclinicaltrialtestersblindedconditionindividualrandomlyassignedoneprimaryanticipatedperformancetasksurveyevaluatesSecondarypredictedincludeneuropsychologicalbatteryLastlyneuroimagingmeasuresusedchangesnetworkssupportingcognitionpreDISCUSSION:whetherelectronicallydeliveredaimedprovidephasegreater3aimbetterunderstandprocessesinvolvedcharacteristicslikelybenefitaddresspotentialobservegeneralizabilitytransfersoftware-basedtooltowardTRIALREGISTRATION:ClinicalTrialsgovNCT03704116Retrospectivelyregistered12Oct2018patients:protocolAttentionCognitiveMemoryPlanningTraumatic

Similar Articles

Cited By