Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2013

Open Access 01-12-2013 | Study protocol

Evaluating the effectiveness of reasoning training in military and civilian chronic traumatic brain injury patients: study protocol

Authors: Daniel C Krawczyk, Carlos Marquez de la Plata, Guido F Schauer, Asha K Vas, Molly Keebler, Stephanie Tuthill, Claire Gardner, Tiffani Jantz, Weikei Yu, Sandra B Chapman

Published in: Trials | Issue 1/2013

Login to get access

Abstract

Background

Individuals who sustain traumatic brain injuries (TBIs) often continue to experience significant impairment of cognitive functions mediated by the prefrontal cortex well into chronic stages of recovery. Traditional brain training programs that focus on improving specific skills fall short of addressing integrative functions that draw upon multiple higher-order processes critical for social and vocational integration. In the current study, we compare the effects of two short-term, intensive, group-based cognitive rehabilitation programs for individuals with chronic TBI. One program emphasizes learning about brain functions and influences on cognition, while the other program adopts a top-down approach to improve abstract reasoning abilities that are largely reliant on the prefrontal cortex. These treatment programs are evaluated in civilian and military veteran TBI populations.

Methods/design

One hundred individuals are being enrolled in this double-blinded clinical trial (all measures and data analyses will be conducted by blinded raters and analysts). Each individual is randomly assigned to one of two treatment conditions, with each condition run in groups of five to seven individuals. The primary anticipated outcomes are improvement in abstract reasoning and everyday life functioning, measured through behavioral tasks and questionnaires, and attention modulation, as measured by functional neuroimaging. Secondary expected outcomes include improvements in the cognitive processes of working memory, attention, and inhibitory control.

Discussion

Results of this trial will determine whether cognitive rehabilitation aimed at teaching TBI-relevant information about the brain and cognition versus training in TBI-affected thinking abilities (e.g., memory, attention, and executive functioning) can improve outcomes in chronic military and civilian TBI patient populations. It should shed light on the nature of improvements and the characteristics of patients most likely to benefit. This trial will also provide information about the sustainability of treatment-related improvements 3 months post-training.

Trial registration

ClinicalTrials.gov Identifier: NCT01552473
Appendix
Available only for authorised users
Literature
1.
Faul M, Xu L, Wald MM, Coronado VG: Traumatic Brain Injury in the United States: Emergency Department Visits, Hospitalizations and Deaths 2002–2006. 2010, Atlanta, GA: Centers for Disease Control and Prevention, National Center for Injury Prevention and Control
2.
Kraus JF, Nourjah P: The epidemiology of mild, uncomplicated brain injury. J Trauma. 1988, 28: 1637-1643. 10.1097/00005373-198812000-00004.CrossRefPubMed
3.
Hoge CW, McGurk D, Thomas JL, Cox AL, Engel CC, Castro CA: Mild traumatic brain injury in U.S. Soldiers returning from Iraq. N Engl J Med. 2008, 358: 453-463. 10.1056/NEJMoa072972.CrossRefPubMed
4.
Hoge CW, Goldberg HM, Castro CA: Care of war veterans with mild traumatic brain injury–flawed perspectives. N Engl J Med. 2009, 360: 1588-1591. 10.1056/NEJMp0810606.CrossRefPubMed
5.
Arciniegas DB, Frey KL, Newman J, Wortzel HS: Evaluation and Management of Posttraumatic Cognitive Impairments. Psychiatr Ann. 2010, 40: 540-552. 10.3928/00485713-20101022-05.CrossRefPubMedPubMedCentral
6.
Dikmen SS, Machamer JE, Powell JM, Temkin NR: Outcome 3 to 5 years after moderate to severe traumatic brain injury. Arch Phys Med Rehabil. 2003, 84: 1449-1457. 10.1016/S0003-9993(03)00287-9.CrossRefPubMed
7.
Chen AJ, Abrams GM, D’Esposito M: Functional reintegration of prefrontal neural networks for enhancing recovery after brain injury. J Head Trauma Rehabil. 2006, 21: 107-118. 10.1097/00001199-200603000-00004.CrossRefPubMed
8.
Novakovic-Agopian T, Chen AJ, Rome S, Abrams G, Castelli H, Rossi A: Rehabilitation of executive functioning with training in attention regulation applied to individually defined goals: a pilot study bridging theory, assessment, and treatment. J Head Trauma Rehabil. 2011, 26: 325-338. 10.1097/HTR.0b013e3181f1ead2.CrossRefPubMed
9.
Chen AJ, Novakovic-Agopian T, Nycum TJ, Song S, Turner GR, Hills NK: Training of goal-directed attention regulation enhances control over neural processing for individuals with brain injury. Brain. 2011, 134: 1541-1554. 10.1093/brain/awr067.CrossRefPubMed
10.
Vas AK, Chapman SB, Cook LG, Elliott AC, Keebler M: Higher-order reasoning training years after traumatic brain injury in adults. J Head Trauma Rehabil. 2011, 26: 224-239. 10.1097/HTR.0b013e318218dd3d.CrossRefPubMed
11.
Alderman N, Burgess PW, Knight C, Henman C: Ecological validity of a simplified version of the multiple errands shopping task. J Int Neuropsychol Soc. 2003, 12: 194-209.
12.
Spikman JM, Boelen DHE, Lamberts KF, Brouwer WH, Luciano F: Effects of a multifaceted treatment program for executive dysfunction after acquired brain injury on indications of executive functioning in daily life. J Int Neuropsychol Soc. 2011, 12: 118-129.
13.
Wilson JT, Pettigrew LE, Teasdale GM: Structured interviews for the Glasgow Outcome Scale and the extended Glasgow Outcome Scale: guidelines for their use. J Neurotrauma. 1998, 15: 573-585. 10.1089/neu.1998.15.573.CrossRefPubMed
14.
Chard KM, Schumm JA, McIlvain SM, Bailey GW, Parkinson BR: Exploring the efficacy of a residential treatment program incorporating cognitive processing therapy-cognitive for veterans with PTSD and traumatic brain injury. J Trauma Stress. 2011, 24: 347-351. 10.1002/jts.20644.CrossRefPubMed
15.
Weathers FLB, Herman D, Huska J, Keane T: The PTSD Checklist (PCL): reliability, validity, and diagnostic utility. 1993, San Antonio: In Annual Meeting of the Internation Society of Traumatic Stress Studies
16.
Wechsler D: Wechsler test of adult reading. 2001, San Antonio, TX: The Psychological Corporation
17.
Bush K, Kivlahan DR, McDonell MB, Fihn SD, Bradley KA: The AUDIT alcohol consumption questions (AUDIT-C): an effective brief screening test for problem drinking. Ambulatory Care Quality Improvement Project (ACQUIP). Alcohol Use Disorders Identification Test. Arch Intern Med. 1998, 158: 1789-1795. 10.1001/archinte.158.16.1789.CrossRefPubMed
18.
Humeniuk VD, Dennington V, Ali R: A technical report of Phase III findings of the WHO ASSIST Randomized Controlled Trial. 2008, Geneva Switzerland: World Health Organization
19.
Dikmen S, Machamer J, Miller B, Doctor J, Temkin N: Functional status examination: a new instrument for assessing outcome in traumatic brain injury. J Neurotrauma. 2001, 18: 127-140. 10.1089/08977150150502578.CrossRefPubMed
20.
Wechsler D: Wechsler Abbreviated Scale of Intelligence (WASI). 1999, San Antonio, TX: Pearson Education, Inc
21.
Wechsler D: Wechsler Adult Intelligence Scale – Third Edition (WAIS–III). 1997, San Antonio, TX: Pearson Education, Inc
22.
Wechsler D: Wechsler Memory Scale – Fourth Edition (WMS-IV). 2008, San Antonio, TX: Pearson Education, Inc
23.
Delis DC, Kaplan E, Kramer JH: D-KEFS Executive Function System: examiners manual. 2001, San Antonio, TX: Pearson Education, Inc
24.
Willer BRM, Kreutzer JS, Gordon WA, Rempel R: Assessment of community integration following rehabilitation for traumatic brain injury. J Head Trauma Rehabil. 1993, 8: 75-87. 10.1097/00001199-199308020-00009.CrossRef
25.
Daneman MC, Carpenter PA: Individual differences in working memory and reading. J Verb Learn Verb Behav. 1980, 19: 450-466. 10.1016/S0022-5371(80)90312-6.CrossRef
26.
Burgess PS, Shallice T: The Hayling and Brixton Tests: Test manual. 1997, UK: Bury St Edmunds
27.
Beck AT, Steer RA, Ball R, Ranieri W: Comparison of Beck Depression Inventories -IA and -II in psychiatric outpatients. J Pers Assess. 1996, 67: 588-597. 10.1207/s15327752jpa6703_13.CrossRefPubMed
28.
Diener E, Emmons RA, Larsen RJ, Griffin S: The Satisfaction With Life Scale. J Pers Assess. 1985, 49: 71-75. 10.1207/s15327752jpa4901_13.CrossRefPubMed
29.
30.
Hanten G, Chapman SB, Gamino JF, Zhang L, Benton SB, Stallings-Roberson G: Verbal selective learning after traumatic brain injury in children. Ann Neurol. 2004, 56: 847-853. 10.1002/ana.20298.CrossRefPubMed
31.
Krawczyk DC, Morrison RG, Viskontas I, Holyoak KJ, Chow TW, Mendez MF: Distraction during relational reasoning: the role of prefrontal cortex in interference control. Neuropsychologia. 2008, 46: 2020-2032. 10.1016/j.neuropsychologia.2008.02.001.CrossRefPubMed
32.
Anand R, Chapman SB, Rackley A, Keebler M, Zientz J, Hart J: Gist reasoning training in cognitively normal seniors. Int J Geriatr Psychiatry. 2011, 26: 961-968. 10.1002/gps.2633.CrossRefPubMed
33.
Gamino JF, Chapman SB, Hull EL, Lyon GR: Effects of higher-order cognitive strategy training on gist-reasoning and fact-learning in adolescents. Front Psychol. 2010, 1: 188-CrossRefPubMedPubMedCentral
34.
Binder DTG, O’Connor C, Levine B: Brain HealthWorkshop: Rotman Research Institute, Baycrest, Toronto, ON, Canada; University of California. 2008, Berkeley: CA
35.
Kanwisher N, McDermott J, Chun MM: The fusiform face area: a module in human extrastriate cortex specialized for face perception. J Neurosci. 1997, 17: 4302-4311.PubMed
36.
Epstein R, Kanwisher N: A cortical representation of the local visual environment. Nature. 1998, 392: 598-601. 10.1038/33402.CrossRefPubMed
37.
Aguirre GK, Zarahn E, D’Esposito M: An area within human ventral cortex sensitive to “building” stimuli: evidence and implications. Neuron. 1998, 21: 373-383. 10.1016/S0896-6273(00)80546-2.CrossRefPubMed
38.
Krawczyk DC, Gazzaley A, D’Esposito M: Reward modulation of prefrontal and visual association cortex during an incentive working memory task. Brain Res. 2007, 1141: 168-177.CrossRefPubMed
39.
Zafonte RD, Mann NR, Millis SR, Wood DL, Lee CY, Black KL: Functional outcome after violence related traumatic brain injury. Brain Inj. 1997, 11: 403-407. 10.1080/026990597123395.CrossRefPubMed
40.
Luethcke CA, Bryan CJ, Morrow CE, Isler WC: Comparison of concussive symptoms, cognitive performance, and psychological symptoms between acute blast-versus nonblast-induced mild traumatic brain injury. J Int Neuropsychol Soc. 2011, 17: 36-45. 10.1017/S1355617710001207.CrossRefPubMed
Metadata
Title
Evaluating the effectiveness of reasoning training in military and civilian chronic traumatic brain injury patients: study protocol
Authors
Daniel C Krawczyk
Carlos Marquez de la Plata
Guido F Schauer
Asha K Vas
Molly Keebler
Stephanie Tuthill
Claire Gardner
Tiffani Jantz
Weikei Yu
Sandra B Chapman
Publication date
01-12-2013
Publisher
BioMed Central
Published in
Trials / Issue 1/2013
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-14-29

Other articles of this Issue 1/2013

Trials 1/2013 Go to the issue

Study protocol

Effectiveness and neural mechanisms associated with tDCS delivered to premotor cortex in stroke rehabilitation: study protocol for a randomized controlled trial

Study protocol

Sentinel node in ovarian cancer: study protocol for a phase 1 study

Study protocol

Evaluation of the effectiveness and cost-effectiveness of Families for Health V2 for the treatment of childhood obesity: study protocol for a randomized controlled trial

Study protocol

SMART MOVE - a smartphone-based intervention to promote physical activity in primary care: study protocol for a randomized controlled trial

Methodology

Hospital-admitted COPD patients treated at home using telemedicine technology in The Virtual Hospital Trial: methods of a randomized effectiveness trial

Study protocol

A pilot study of the effect of spironolactone therapy on exercise capacity and endothelial dysfunction in pulmonary arterial hypertension: study protocol for a randomized controlled trial