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Traumatic Brain Injury

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Clinical Trials in Neurology

Abstract

Traumatic brain injury (TBI) is one of the leading causes of disabilities and young adults’ death. Considering all the challenges faced in research involving this field, this book chapter analyses the 100 most cited TBI trials in order to provide methodological recommendations for designing future trials in TBI. A literature review of 100 most cited clinical trials in TBI between 2010 and 2015 was conducted using the web engine: Web of Science. Based on the CONSORT guidelines, a comprehensive discussion of the main findings is provided as to guide and help investigators in this field to design TBI clinical trials.

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References

  1. Faul M, Xu L, Wald MM, Coronado VG (2010) Traumatic brain injury in the United States: emergency department visits, hospitalizations, and deaths. Centers for Disease Control and Prevention, National Center for Injury Prevention and Control, Atlanta, GA, pp 891–904. Available from: http://www.ncbi.nlm.nih.gov/pubmed/23630120

    Book  Google Scholar 

  2. Surgeons AAoN (2015) Traumatic brain injury. Available from: http://www.aans.org/patient information/conditions and treatments/traumatic brain injury.aspx

    Google Scholar 

  3. Wilson M, Zolfaghari P, Griffin C, Lockey D, Tolias C, Verma V (2014) The future of traumatic brain injury research. Scand J Trauma Resusc Emerg Med 22(Suppl 1):A7. Available from: http://www.sjtrem.com/content/22/S1/A7%5Cnpapers3://publication/doi/10.1186/1757-7241-22-S1-A7

    Article  PubMed Central  Google Scholar 

  4. Wright J (2011) Glasgow outcome scale. In: Kreutzer JS, DeLuca J, Caplan B (eds) Encyclopedia of clinical neuropsychology. Springer, New York, NY, pp 1150–1152. Available from: http://link.springer.com/10.1007/978-0-387-79948-3

    Chapter  Google Scholar 

  5. Teasdale G, Murray G, Parker L, Jennett B (1979) Adding up the Glasgow coma score. Acta Neurochir Suppl (Wien) 28:13–16

    CAS  Google Scholar 

  6. Menon DK, Schwab K, Wright DW, Maas AI (2010) Position statement: definition of traumatic brain injury. Arch Phys Med Rehabil 91:1637–1640

    Article  PubMed  Google Scholar 

  7. Maas AI, Menon DK, Lingsma HF, Pineda JA, Sandel ME, Manley GT (2012) Re-orientation of clinical research in traumatic brain injury: report of an international workshop on comparative effectiveness research. J Neurotrauma 29(1):32–46. Available from: http://www.ncbi.nlm.nih.gov/pubmed/21545277%5Cn, http://online.liebertpub.com/doi/pdfplus/10.1089/neu.2010.1599

    Article  PubMed  PubMed Central  Google Scholar 

  8. Maas AIR, Menon DK (2012) Traumatic brain injury: rethinking ideas and approaches. Lancet Neurol 11:12–13

    Article  PubMed  Google Scholar 

  9. Portney LG, Watkins MP (2009) Foundations of clinical research: applications to practice. Pearson Education, Inc., Upper Saddle River, NJ. 892 p

    Google Scholar 

  10. Temkin NR, Anderson GD, Winn HR, Ellenbogen RG, Britz GW, Schuster J et al (2007) Magnesium sulfate for neuroprotection after traumatic brain injury: a randomised controlled trial. Lancet Neurol 6(1):29–38

    Article  CAS  PubMed  Google Scholar 

  11. Couillet J, Soury S, Lebornec G, Asloun S, Joseph PA, Mazaux JM et al (2010) Rehabilitation of divided attention after severe traumatic brain injury: a randomised trial. Neuropsychol Rehabil 20(3):321–339

    Article  PubMed  Google Scholar 

  12. Jha A, Weintraub A, Allshouse A, Morey C, Cusick C, Kittelson J et al (2008) A randomized trial of modafinil for the treatment of fatigue and excessive daytime sleepiness in individuals with chronic traumatic brain injury. J Head Trauma Rehabil 23(1):52–63. Available from: http://content.wkhealth.com/linkback/openurl?sid=WKPTLP:landingpage&an=00001199-200801000-00009

    Article  PubMed  Google Scholar 

  13. Robertson CS, Hannay HJ, Yamal J-M, Gopinath S, Goodman JC, Tilley BC et al (2014) Effect of erythropoietin and transfusion threshold on neurological recovery after traumatic brain injury. JAMA 312(1):36. Available from: http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2014.6490

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  14. Chittester B (2014) Medical device clinical trials – how do they compare with drug trials? Master Control, Inc., Granville, OH. Available from: http://cdn2.hubspot.net/hub/149400/file-646377456-pdf/docs/mc-n-med-dev-trials-compare-with-drug-trials.pdf

    Google Scholar 

  15. Administration USFaD (2015) Step 3: clinical research. [Internet]. [cited 2015 Oct 10]. Available from: http://www.fda.gov/ForPatients/Approvals/Drugs/ucm405622.htm

  16. Food and Drug administration. What does it mean for FDA to “classify” a medical device? [Internet]. [cited .2017 Nov 30]. Available from: https://www.fda.gov/AboutFDA/Transparency/Basics/ucm194438.htm

  17. Cooper DJ, Rosenfeld JV, Murray L, Arabi YM, Davies AR, D’Urso P et al (2011) Decompressive craniectomy in diffuse traumatic brain injury. N Engl J Med 364(16):1493–1502. Available from: http://www.nejm.org/doi/abs/10.1056/NEJMoa1102077

    Article  CAS  PubMed  Google Scholar 

  18. Zygun DA, Nortje J, Hutchinson PJ, Timofeev I, Menon DK, Gupta AK (2009) The effect of red blood cell transfusion on cerebral oxygenation and metabolism after severe traumatic brain injury*. Crit Care Med 37(3):1074–1078. Available from: http://content.wkhealth.com/linkback/openurl?sid=WKPTLP:landingpage&an=00003246-200903000-00040

    Article  CAS  PubMed  Google Scholar 

  19. Adelson PD, Ragheb J, Muizelaar JP, Kanev P, Brockmeyer D, Beers SR et al (2005) Phase II clinical trial of moderate hypothermia after severe traumatic brain injury in children. Neurosurgery 56(4):740–753

    Article  PubMed  Google Scholar 

  20. Bourgeois MS, Lenius K, Turkstra L, Camp C (2007) The effects of cognitive teletherapy on reported everyday memory behaviours of persons with chronic traumatic brain injury. Brain Inj 21(12):1245–1257. Available from: http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=emed8&AN=2008061172, http://sfxhosted.exlibrisgroup.com/cmc?sid=OVID:embase&id=pmid:&id=doi:10.1080%2F02699050701727452&issn=0269-9052&isbn=&volume=21&issue=12&spage=1245&pages=1245-1257&

    Article  PubMed  Google Scholar 

  21. Rivera PA, Elliott TR, Berry JW, Grant JS (2008) Problem-solving training for family caregivers of persons with traumatic brain injuries: a randomized controlled trial. Arch Phys Med Rehabil 89(5):931–941

    Article  PubMed  PubMed Central  Google Scholar 

  22. Galbiati S, Recla M, Pastore V, Liscio M, Bardoni A, Castelli E et al (2009) Attention remediation following traumatic brain injury in childhood and adolescence. Neuropsychology 23(1):40–49. Available from: http://doi.apa.org/getdoi.cfm?doi=10.1037/a0013409

    Article  PubMed  Google Scholar 

  23. Thaut MH, Gardiner JC, Holmberg D, Horwitz J, Kent L, Andrews G et al (2009) Neurologic music therapy improves executive function and emotional adjustment in traumatic brain injury rehabilitation. Ann N Y Acad Sci 1169:406–416

    Article  PubMed  Google Scholar 

  24. Bernard SA, Nguyen V, Cameron P, Masci K, Fitzgerald M, Cooper DJ et al (2010) Prehospital rapid sequence intubation improves functional outcome for patients with severe traumatic brain injury: a randomized controlled trial. Ann Surg 252:959–965

    Article  PubMed  Google Scholar 

  25. Jiang JY, Xu W, Li WP, Gao GY, Bao YH, Liang YM et al (2006) Effect of long-term mild hypothermia or short-term mild hypothermia on outcome of patients with severe traumatic brain injury. J Cereb Blood Flow Metab 26(6):771–776. Available from: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=16306933

    Article  PubMed  Google Scholar 

  26. Jiang J-Y, Xu W, Li W-P, Xu W-H, Zhang J, Bao Y-H et al (2005) Efficacy of standard trauma craniectomy for refractory intracranial hypertension with severe traumatic brain injury: a multicenter, prospective, randomized controlled study. J Neurotrauma 22(6):623–628. Available from: http://www.liebertonline.com/doi/abs/10.1089/neu.2005.22.623

    Article  PubMed  Google Scholar 

  27. Qiu W, Guo C, Shen H, Chen K, Wen L, Huang H et al (2009) Effects of unilateral decompressive craniectomy on patients with unilateral acute post-traumatic brain swelling after severe traumatic brain injury. Crit Care 13(6):R185. Available from: http://ccforum.biomedcentral.com/articles/10.1186/cc8178

    Article  PubMed  PubMed Central  Google Scholar 

  28. Qiu W, Zhang Y, Sheng H, Zhang J, Wang W, Liu W et al (2007) Effects of therapeutic mild hypothermia on patients with severe traumatic brain injury after craniotomy. J Crit Care 22(3):229–235

    Article  PubMed  Google Scholar 

  29. Adelson PD, Wisniewski SR, Beca J, Brown SD, Bell M, Muizelaar JP et al (2013) Comparison of hypothermia and normothermia after severe traumatic brain injury in children (Cool Kids): a phase 3, randomised controlled trial. Lancet Neurol 12(6):546–553

    Article  PubMed  Google Scholar 

  30. Katz-Leurer M, Rotem H, Keren O, Meyer S (2009) The effects of a ‘home-based’ task-oriented exercise programme on motor and balance performance in children with spastic cerebral palsy and severe traumatic brain injury. Clin Rehabil 23(8):714–724. Available from: http://journals.sagepub.com/doi/10.1177/0269215509335293

    Article  PubMed  Google Scholar 

  31. O’Brien A et al (2007) An investigation of the differential effect of self-generation to improve learning and memory in multiple sclerosis and traumatic brain injury. Neuropsychol Rehabil 17(3):273–282. Available from: http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=reference&D=med5&NEWS=N&AN=17474057%5Cn, http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=reference&D=emed8&NEWS=N&AN=2007218094

    Article  PubMed  Google Scholar 

  32. Patrick P, Blackman J, Mabry J, Buck M, Gurka M, Conaway M (2006) Dopamine agonist therapy in low-response children following traumatic brain injury. J Child Neurol 21:879–885. Available from: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/476/CN-00572476/frame.html

    Article  PubMed  Google Scholar 

  33. Tisdall MM, Tachtsidis I, Leung TS, Elwell CE, Smith M (2008) Increase in cerebral aerobic metabolism by normobaric hyperoxia after traumatic brain injury. J Neurosurg 109(3):424–432. Available from: http://thejns.org/doi/10.3171/JNS/2008/109/9/0424

    Article  PubMed  Google Scholar 

  34. Coester A, Neumann CR, Schmidt MI (2010) Intensive insulin therapy in severe traumatic brain injury: a randomized trial. J Trauma 68:904. Available from: http://content.wkhealth.com/linkback/openurl?sid=WKPTLP:landingpage&an=00005373-900000000-99649

    PubMed  CAS  Google Scholar 

  35. Vanderploeg RD, Schwab K, Walker WC, Fraser JA, Sigford BJ, Date ES et al (2008) Rehabilitation of traumatic brain injury in active duty military personnel and veterans: defense and veterans brain injury center randomized controlled trial of two rehabilitation approaches. Arch Phys Med Rehabil 89(12):2227–2238. Available from: http://linkinghub.elsevier.com/retrieve/pii/S0003999308014858

    Article  PubMed  Google Scholar 

  36. Zhu XL, Poon WS, Chan CCH, Chan SSH (2007) Does intensive rehabilitation improve the functional outcome of patients with traumatic brain injury (TBI)? A randomized controlled trial. Brain Inj 21(7):681–690. Available from: http://www.tandfonline.com/doi/full/10.1080/02699050701468941

    Article  CAS  PubMed  Google Scholar 

  37. Silver JM, Koumaras B, Meng X, Potkin SG, Reyes PF, Harvey PD et al (2009) Long-term effects of rivastigmine capsules in patients with traumatic brain injury. Brain Inj 23(2):123–132

    Article  PubMed  Google Scholar 

  38. High WM, Roebuck-Spencer T, Sander AM, Struchen MA, Sherer M (2006) Early versus later admission to postacute rehabilitation: impact on functional outcome after traumatic brain injury. Arch Phys Med Rehabil 87(3):334–342. Available from: http://linkinghub.elsevier.com/retrieve/pii/S0003999305014693

    Article  PubMed  Google Scholar 

  39. Bhambhani Y, Rowland G, Farag M (2005) Effects of circuit training on body composition and peak cardiorespiratory responses in patients with moderate to severe traumatic brain injury. Arch Phys Med Rehabil 86(2):268–276. Available from: http://linkinghub.elsevier.com/retrieve/pii/S0003999304004721

    Article  PubMed  Google Scholar 

  40. Wright DW, Kellermann AL, Hertzberg VS, Clark PL, Frankel M, Goldstein FC et al (2007) ProTECT: a randomized clinical trial of progesterone for acute traumatic brain injury. Ann Emerg Med 49(4):391

    Article  PubMed  Google Scholar 

  41. Vespa P, McArthur DL, Stein N, Huang S-C, Shao W, Filippou M et al (2012) Tight glycemic control increases metabolic distress in traumatic brain injury. Crit Care Med 40(6):1923–1929. Available from: http://content.wkhealth.com/linkback/openurl?sid=WKPTLP:landingpage&an=00003246-201206000-00031

    Article  CAS  PubMed  Google Scholar 

  42. Ashman TA, Cantor JB, Gordon WA, Spielman L, Flanagan S, Ginsberg A et al (2009) A randomized controlled trial of sertraline for the treatment of depression in persons with traumatic brain injury. Arch Phys Med Rehabil 90(5):733–740. Available from: http://linkinghub.elsevier.com/retrieve/pii/S0003999309000835

    Article  PubMed  Google Scholar 

  43. Kraus MF, Smith GS, Butters M, Donnell AJ, Dixon E, Yilong C et al (2005) Effects of the dopaminergic agent and NMDA receptor antagonist amantadine on cognitive function, cerebral glucose metabolism and D2 receptor availability in chronic traumatic brain injury: a study using positron emission tomography (PET). Brain Inj 19(7):471–479. Available from: http://www.tandfonline.com/doi/full/10.1080/02699050400025059

    Article  CAS  PubMed  Google Scholar 

  44. Bilotta F, Caramia R, Cernak I, Paoloni FP, Doronzio A, Cuzzone V et al (2008) Intensive insulin therapy after severe traumatic brain injury: a randomized clinical trial. Neurocrit Care 9(2):159–166. Available from: http://link.springer.com/10.1007/s12028-008-9084-9

    Article  CAS  PubMed  Google Scholar 

  45. Bulger EM, May S, Brasel KJ, Schreiber M, Kerby JD, Tisherman SA et al (2010) Out-of-hospital hypertonic resuscitation following severe traumatic brain injury: a randomized controlled trial. JAMA 304(13):1455–1464

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  46. Yurkewicz L, Weaver J, Bullock MR, Marshall LF (2005) The effect of the selective NMDA receptor antagonist traxoprodil in the treatment of traumatic brain injury. J Neurotrauma 22(12):1428–1443. Available from: http://www.liebertonline.com/doi/abs/10.1089/neu.2005.22.1428

    Article  PubMed  Google Scholar 

  47. Maas AIR, Murray G, Henney H, Kassem N, Legrand V, Mangelus M et al (2006) Efficacy and safety of dexanabinol in severe traumatic brain injury: results of a phase III randomised, placebo-controlled, clinical trial. Lancet Neurol 5(1):38–45

    Article  CAS  PubMed  Google Scholar 

  48. Zafonte RD, Bagiella E, Ansel BM, Novack TA, Friedewald WT, Hesdorffer DC et al (2012) Effect of citicoline on functional and cognitive status among patients with traumatic brain injury: citicoline brain injury treatment trial (COBRIT). JAMA 308(19):1993–2000. Available from: http://jama.jamanetwork.com/data/Journals/JAMA/25500/joc120094_1993_2000.pdf

    Article  CAS  PubMed  Google Scholar 

  49. Chesnut RM, Temkin N, Carney N, Dikmen S, Rondina C, Videtta W et al (2012) A trial of intracranial-pressure monitoring in traumatic brain injury. N Engl J Med 367(26):2471–2481. Available from: http://www.nejm.org/doi/abs/10.1056/NEJMoa1207363

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  50. Rockswold SB, Rockswold GL, Zaun DA, Zhang X, Cerra CE, Bergman TA et al (2010) A prospective, randomized clinical trial to compare the effect of hyperbaric to normobaric hyperoxia on cerebral metabolism, intracranial pressure, and oxygen toxicity in severe traumatic brain injury. J Neurosurg 112(5):1080–1094. Available from: http://thejns.org/doi/10.3171/2009.7.JNS09363

    Article  CAS  PubMed  Google Scholar 

  51. Zhang Z-X, Guan L-X, Zhang K, Zhang Q, Dai L-J (2008) A combined procedure to deliver autologous mesenchymal stromal cells to patients with traumatic brain injury. Cytotherapy 10(2):134–139. Available from: http://linkinghub.elsevier.com/retrieve/pii/S146532490870166X

    Article  CAS  PubMed  Google Scholar 

  52. Acosta-Escribano J, Fernández-Vivas M, Grau Carmona T, Caturla-Such J, Garcia-Martinez M, Menendez-Mainer A et al (2010) Gastric versus transpyloric feeding in severe traumatic brain injury: a prospective, randomized trial. Intensive Care Med 36(9):1532–1539. Available from: http://link.springer.com/10.1007/s00134-010-1908-3

    Article  PubMed  Google Scholar 

  53. Cox CS, Baumgartner JE, Harting MT, Worth LL, Walker PA, Shah SK et al (2011) Autologous bone marrow mononuclear cell therapy for severe traumatic brain injury in children. Neurosurgery 68(3):588–600. Available from: https://academic.oup.com/neurosurgery/article-lookup/doi/10.1227/NEU.0b013e318207734c

    Article  PubMed  Google Scholar 

  54. Zhao Q-J, Zhang X-G, Wang L-X (2011) Mild hypothermia therapy reduces blood glucose and lactate and improves neurologic outcomes in patients with severe traumatic brain injury. J Crit Care 26(3):311–315. Available from: http://linkinghub.elsevier.com/retrieve/pii/S0883944110002418

    Article  CAS  PubMed  Google Scholar 

  55. Bell KR, Temkin NR, Esselman PC, Doctor JN, Bombardier CH, Fraser RT et al (2005) The effect of a scheduled telephone intervention on outcome after moderate to severe traumatic brain injury: a randomized trial. Arch Phys Med Rehabil 86(5):851–856. Available from: http://linkinghub.elsevier.com/retrieve/pii/S0003999304013930

    Article  PubMed  Google Scholar 

  56. Cooper DJ, Myburgh J, Heritier S, Finfer S, Bellomo R, Billot L et al (2013) Albumin resuscitation for traumatic brain injury: is intracranial hypertension the cause of increased mortality? J Neurotrauma 30(7):512–518. Available from: http://online.liebertpub.com/doi/abs/10.1089/neu.2012.2573

    Article  PubMed  PubMed Central  Google Scholar 

  57. Lee H, Kim SW, Shin IS, Yang SJ, Yoon JS (2005) Comparing effects of methylphenidate, sertraline and placebo on neuropsychiatric sequelae in patients with traumatic brain injury. Hum Psychopharmacol 20(2):97–104

    Article  CAS  PubMed  Google Scholar 

  58. Silver JM, Koumaras B, Chen M, Mirski D, Potkin SG, Reyes P et al (2006) Effects of rivastigmine on cognitive function in patients with traumatic brain injury. Neurology 67:748–755. Available from: http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=reference&D=emed7&NEWS=N&AN=2006453041

    Article  CAS  PubMed  Google Scholar 

  59. High WM, Briones-Galang M, Clark JA, Gilkison C, Mossberg KA, Zgaljardic DJ et al (2010) Effect of growth hormone replacement therapy on cognition after traumatic brain injury. J Neurotrauma 27(9):1565–1575. Available from: http://www.liebertonline.com/doi/abs/10.1089/neu.2009.1253

    Article  PubMed  PubMed Central  Google Scholar 

  60. Kim Y-H, Ko M-H, Na S-Y, Park S-H, Kim K-W (2006) Effects of single-dose methylphenidate on cognitive performance in patients with traumatic brain injury: a double-blind placebo-controlled study. Clin Rehabil 20(1):24–30. Available from: http://journals.sagepub.com/doi/10.1191/0269215506cr927oa

    Article  PubMed  Google Scholar 

  61. Beers SR, Skold A, Dixon CE, Adelson PD (2005) Neurobehavioral effects of amantadine after pediatric traumatic brain injury: a preliminary report. J Head Trauma Rehabil 20:450–463. Available from: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/349/CN-00530349/frame.html

    Article  PubMed  Google Scholar 

  62. Kaiser PR, Valko PO, Werth E, Thomann J, Meier J, Stocker R et al (2010) Modafinil ameliorates excessive daytime sleepiness after traumatic brain injury. Neurology 75(20):1780–1785. Available from: http://www.neurology.org/cgi/doi/10.1212/WNL.0b013e3181fd62a2

    Article  CAS  PubMed  Google Scholar 

  63. Ponsford JL, Myles PS, Cooper DJ, Mcdermott FT, Murray LJ, Laidlaw J et al (2008) Gender differences in outcome in patients with hypotension and severe traumatic brain injury. Injury 39(1):67–76. Available from: http://linkinghub.elsevier.com/retrieve/pii/S0020138307003555

    Article  PubMed  Google Scholar 

  64. Xiao G, Wei J, Yan W, Wang W, Lu Z (2008) Improved outcomes from the administration of progesterone for patients with acute severe traumatic brain injury: a randomized controlled trial. Crit Care 12(2):R61. Available from: http://ccforum.biomedcentral.com/articles/10.1186/cc6887

    Article  PubMed  PubMed Central  Google Scholar 

  65. Baker AJ, Rhind SG, Morrison LJ, Black S, Crnko NT, Shek PN et al (2009) Resuscitation with hypertonic saline–dextran reduces serum biomarker levels and correlates with outcome in severe traumatic brain injury patients. J Neurotrauma 26(8):1227–1240. Available from: http://www.liebertonline.com/doi/abs/10.1089/neu.2008.0868

    Article  PubMed  Google Scholar 

  66. Sakellaris G, Kotsiou M, Tamiolaki M, Kalostos G, Tsapaki E, Spanaki M et al (2006) Prevention of complications related to traumatic brain injury in children and adolescents with creatine administration: an open label randomized pilot study. J Trauma Inj Infect Crit Care 61(2):322–329. Available from: http://content.wkhealth.com/linkback/openurl?sid=WKPTLP:landingpage&an=00005373-200608000-00011

    Article  CAS  Google Scholar 

  67. Tiersky LA, Anselmi V, Johnston MV, Kurtyka J, Roosen E, Schwartz T et al (2005) A trial of neuropsychologic rehabilitation in mild-spectrum traumatic brain injury. Arch Phys Med Rehabil 86(8):1565–1574

    Article  PubMed  Google Scholar 

  68. Buttram SDW, Wisniewski SR, Jackson EK, Adelson PD, Feldman K, Bayir H et al (2007) Multiplex assessment of cytokine and chemokine levels in cerebrospinal fluid following severe pediatric traumatic brain injury: effects of moderate hypothermia. J Neurotrauma 24(November):1707–1717

    Article  PubMed  Google Scholar 

  69. Harris OA, Muh CR, Surles MC, Pan Y, Rozycki G, Macleod J et al (2009) Discrete cerebral hypothermia in the management of traumatic brain injury: a randomized controlled trial. J Neurosurg 110:1256–1264. Available from: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/002/CN-00707002/frame.html

    Article  PubMed  Google Scholar 

  70. Puccio AM, Fischer MR, Jankowitz BT, Yonas H, Darby JM, Okonkwo DO (2009) Induced normothermia attenuates intracranial hypertension and reduces fever burden after severe traumatic brain injury. Neurocrit Care 11(1):82–87

    Article  PubMed  PubMed Central  Google Scholar 

  71. Bayir H, Adelson PD, Wisniewski SR, Shore P, Lai Y, Brown D et al (2009) Therapeutic hypothermia preserves antioxidant defenses after severe traumatic brain injury in infants and children. [Erratum appears in Crit Care Med. 2009;37(4):1536]. Crit Care Med 37(2):689–695

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  72. Liu WG, Qiu WS, Zhang Y, Wang WM, Lu F, Yang XF (2006) Effects of selective brain cooling in patients with severe traumatic brain injury: a preliminary study. J Int Med Res 34(1):58–64. Available from: http://imr.sagepub.com/content/34/1/58.short

    Article  CAS  PubMed  Google Scholar 

  73. Wolf G, Cifu D, Baugh L, Carne W, Profenna L (2012) The effect of hyperbaric oxygen on symptoms after mild traumatic brain injury. J Neurotrauma 29:2606–2612

    Article  PubMed  Google Scholar 

  74. Andrews PJD, Sinclair HL, Battison CG, Polderman KH, Citerio G, Mascia L et al (2011) European society of intensive care medicine study of therapeutic hypothermia (32-35 °C) for intracranial pressure reduction after traumatic brain injury (the Eurotherm3235Trial). Trials 12(1):8. Available from: http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=3027122&tool=pmcentrez&rendertype=abstract

    Article  PubMed  PubMed Central  Google Scholar 

  75. Adamides AA, Cooper DJ, Rosenfeldt FL, Bailey MJ, Pratt N, Tippett N et al (2009) Focal cerebral oxygenation and neurological outcome with or without brain tissue oxygen-guided therapy in patients with traumatic brain injury. Acta Neurochir 151(11):1399–1409. Available from: http://link.springer.com/10.1007/s00701-009-0398-y

    Article  CAS  PubMed  Google Scholar 

  76. Hutchison JS, Ward RE, Lacroix J, Hébert PC, Barnes MA, Bohn DJ et al (2008) Hypothermia therapy after traumatic brain injury in children. N Engl J Med 358(23):2447–2456. Available from: papers://72c6f5a3-fe57-4d09-a143-5358ae4043f5/Paper/p142

    Article  CAS  Google Scholar 

  77. Giacino JT, Whyte J, Bagiella E, Kalmar K, Childs N, Khademi A et al (2012) Placebo-controlled trial of amantadine for severe traumatic brain injury. N Engl J Med 366(9):819–826. Available from: http://www.nejm.org/doi/abs/10.1056/NEJMoa1102609

    Article  CAS  PubMed  Google Scholar 

  78. Andelic N, Bautz-Holter E, Ronning P, Olafsen K, Sigurdardottir S, Schanke A-K et al (2012) Does an early onset and continuous chain of rehabilitation improve the long-term functional outcome of patients with severe traumatic brain injury? J Neurotrauma 29(1):66–74. Available from: http://www.liebertonline.com/doi/abs/10.1089/neu.2011.1811

    Article  PubMed  Google Scholar 

  79. Brookes ST, Whitely E, Egger M, Smith GD, Mulheran PA, Peters TJ (2004) Subgroup analyses in randomized trials: risks of subgroup-specific analyses; power and sample size for the interaction test. J Clin Epidemiol 57(3):229–236

    Article  PubMed  Google Scholar 

  80. Brown TH, Mount J, Rouland BL, Kautz KA, Barnes RM, Kim J (2005) Body weight-supported treadmill training versus conventional gait training for people with chronic traumatic brain injury. J Head Trauma Rehabil 20(5):402–415. Available from: http://content.wkhealth.com/linkback/openurl?sid=WKPTLP:landingpage&an=00001199-200509000-00002

    Article  PubMed  Google Scholar 

  81. Mazzeo AT, Brophy GM, Gilman CB, Alves OL, Robles JR, Hayes RL et al (2009) Safety and tolerability of cyclosporin a in severe traumatic brain injury patients: results from a prospective randomized trial. J Neurotrauma 26:2195–2206. Available from: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/583/CN-00734583/frame.html

    Article  PubMed  PubMed Central  Google Scholar 

  82. Olivecrona M, Rodling-Wahlstrom M, Naredi S, Koskinen LO (2009) Prostacyclin treatment in severe traumatic brain injury: a microdialysis and outcome study. J Neurotrauma 26(8):1251–1262

    Article  PubMed  Google Scholar 

  83. Cheng SKW, Man DWK (2006) Management of impaired self-awareness in persons with traumatic brain injury. Brain Inj 20(6):621–628

    Article  CAS  PubMed  Google Scholar 

  84. Wade SL, Michaud L, Brown TM (2006) Putting the pieces together: preliminary efficacy of a family problem-solving intervention for children with traumatic brain injury. J Head Trauma Rehabil 21:57–67. Available from: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/924/CN-00554924/frame.html

    Article  PubMed  Google Scholar 

  85. Moein H, Khalili HA, Keramatian K (2006) Effect of methylphenidate on ICU and hospital length of stay in patients with severe and moderate traumatic brain injury. Clin Neurol Neurosurg 108(6):539–542

    Article  PubMed  Google Scholar 

  86. Marmarou A, Guy M, Murphey L, Roy F, Layani L, Combal J-P et al (2005) A single dose, three-arm, placebo-controlled, phase i study of the bradykinin B2 receptor antagonist anatibant (LF16-0687Ms) in patients with severe traumatic brain injury. J Neurotrauma 22(12):1444–1455. Available from: http://www.liebertonline.com/doi/abs/10.1089/neu.2005.22.1444

    Article  PubMed  Google Scholar 

  87. Hoffer ME, Balaban C, Slade MD, Tsao JW, Hoffer B (2013) Amelioration of acute sequelae of blast induced mild traumatic brain injury by n-acetyl cysteine: a double-blind, placebo controlled study. PLoS One 8(1):e54163

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  88. Mazzeo AT, Alves OL, Gilman CB, Hayes RL, Tolias C, Niki Kunene K et al (2008) Brain metabolic and hemodynamic effects of cyclosporin A after human severe traumatic brain injury: a microdialysis study. Acta Neurochir 150(10):1019–1031. discussion 1031. Available from: http://www.ncbi.nlm.nih.gov/pubmed/18781275

    Article  PubMed  Google Scholar 

  89. Schiff ND, Giacino JT, Kalmar K, Victor JD, Baker K, Gerber M et al (2007) Behavioural improvements with thalamic stimulation after severe traumatic brain injury. Nature 448(7153):600–603

    Article  CAS  PubMed  Google Scholar 

  90. Sarajuuri JM, Kaipio ML, Koskinen SK, Niemelä MR, Servo AR, Vilkki JS (2005) Outcome of a comprehensive neurorehabilitation program for patients with traumatic brain injury. Arch Phys Med Rehabil 86(12):2296–2302. Available from: http://linkinghub.elsevier.com/retrieve/pii/S0003999305009172

    Article  PubMed  Google Scholar 

  91. Ouellet M-C, Morin CM (2007) Efficacy of cognitive-behavioral therapy for insomnia associated with traumatic brain injury: a single-case experimental design. Arch Phys Med Rehabil 88(12):1581–1592. Available from: http://linkinghub.elsevier.com/retrieve/pii/S0003999307015560

    Article  PubMed  Google Scholar 

  92. Empey PE et al (2006) Cyclosporin A disposition following acute traumatic brain injury. J Neurotrauma 23:109–116. Available from: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/206/CN-00562206/frame.html

    Article  PubMed  Google Scholar 

  93. Mazzeo AT, Kunene NK, Gilman CB, Hamm RJ, Hafez N, Bullock MR (2006) Severe human traumatic brain injury, but not cyclosporin a treatment, depresses activated T lymphocytes early after injury. J Neurotrauma 23(6):962–975

    Article  PubMed  Google Scholar 

  94. Tapia-Perez JH, Sanchez-Aguilar M, Torres-Corzo JG, Gordillo-Moscoso A, Martinez-Perez P, Madeville P et al (2008) Effect of rosuvastatin on amnesia and disorientation after traumatic brain injury (NCT00329758). J Neurotrauma 25(8):1011–1017. Available from: http://online.liebertpub.com/doi/10.1089/neu.2008.0554

    Article  PubMed  Google Scholar 

  95. Yang M, Guo Q, Zhang X, Sun S, Wang Y, Zhao L et al (2009) Intensive insulin therapy on infection rate, days in NICU, in-hospital mortality and neurological outcome in severe traumatic brain injury patients: a randomized controlled trial. Int J Nurs Stud 46(6):753–758. Available from: http://linkinghub.elsevier.com/retrieve/pii/S002074890900008X

    Article  PubMed  Google Scholar 

  96. Wright DW, Ritchie JC, Mullins RE, Kellermann AL, Denson DD (2005) Steady-state serum concentrations of progesterone following continuous intravenous infusion in patients with acute moderate to severe traumatic brain injury. J Clin Pharmacol 45(6):640–648. Available from: http://www.ncbi.nlm.nih.gov/pubmed/15901745

    Article  CAS  PubMed  Google Scholar 

  97. Willmott C, Ponsford J (2009) Efficacy of methylphenidate in the rehabilitation of attention following traumatic brain injury: a randomised, crossover, double blind, placebo controlled inpatient trial. J Neurol Neurosurg Psychiatry 80(5):552–557. Available from: http://jnnp.bmj.com/cgi/doi/10.1136/jnnp.2008.159632

    Article  CAS  PubMed  Google Scholar 

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Zaninotto, A.L.C., Costa, B.T., Ferreira, I.S., French, M., Paiva, W.S., Fregni, F. (2018). Traumatic Brain Injury. In: Fregni, F. (eds) Clinical Trials in Neurology. Neuromethods, vol 138. Humana Press, New York, NY. https://doi.org/10.1007/978-1-4939-7880-9_4

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