Cited by 913Traumatic Brain Injury and Neurovascular DisturbancesTraumatic Brain Injury ResearchAutomotive and Human Injury Biomechanics

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Clinical Trials in Head Injury

Open access

Narayan, Raj K., Michel, Mary Ellen, Ansell, Beth, Baethmann, Alex, Biegon, Anat, Bracken, Michael B., Bullock, M. Ross, Choi, Sung C., Clifton, Guy L., Contant, Charles F., Coplin, William M., Dietrich, W. Dalton, Ghajar, Jamshid, Grady, Sean M., Grossman, Robert G., Hall, Edward D., Heetderks, William, Hovda, David A., Jallo, Jack, Katz, Russell L., Knoller, Nachshon, Kochanek, Patrick M., Maas, Andrew I., Majde, Jeannine, Marion, Donald W., Marmarou, Anthony, Marshall, Lawrence F., McIntosh, Tracy K., Miller, Emmy, Mohberg, Noel, Muizelaar, J. Paul, Pitts, Lawrence H., Quinn, Peter, Riesenfeld, Gad, Robertson, Claudia S., Strauss, Kenneth I., Teasdale, Graham, Temkin, Nancy, Tuma, Ronald, Wade, Charles, Walker, Michael D., Weinrich, Michael, Whyte, John, Wilberger, Jack, Young, A. Byron, Yurkewicz, Lorraine·2002·Journal of Neurotrauma

DOI 10.1089/089771502753754037PMC PMC1462953

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Abstract

Traumatic brain injury (TBI) remains a major public health problem globally. In the United States the incidence of closed head injuries admitted to hospitals is conservatively estimated to be 200 per 100,000 population, and the incidence of penetrating head injury is estimated to be 12 per 100,000, the highest of any developed country in the world. This yields an approximate number of 500,000 new cases each year, a sizeable proportion of which demonstrate significant long-term disabilities. Unfortunately, there is a paucity of proven therapies for this disease. For a variety of reasons, clinical trials for this condition have been difficult to design and perform. Despite promising pre-clinical data, most of the trials that have been performed in recent years have failed to demonstrate any significant improvement in outcomes. The reasons for these failures have not always been apparent and any insights gained were not always shared. It was therefore feared that we were running the risk of repeating our mistakes. Recognizing the importance of TBI, the National Institute of Neurological Disorders and Stroke (NINDS) sponsored a workshop that brought together experts from clinical, research, and pharmaceutical backgrounds. This workshop proved to be very informative and yielded many insights into previous and future TBI trials. This paper is an attempt to summarize the key points made at the workshop. It is hoped that these lessons will enhance the planning and design of future efforts in this important field of research.

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The International Stroke Trial (IST): a randomised trial of aspirin, subcutaneous heparin, both, or neither among 19 435 patients with acute ischaemic stroke
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“…et al., 1996; Yakovlev et al., 2001), experimental studies using anti-inﬂammatory drugs for the treatment of TBI have shown varying results, with both neuroprotective and no effects reported (Gahm et al., 2005; Holmin and Mathiesen, 1996; Molad, 2002; Narayan et al., 2002; Sanderson et al., 1999).”
Effect of therapeutic moderate hypothermia on multi-drug resistance protein 1-mediated transepithelial transport of drugs.
Jin, J.-S., Sakaeda, T., Kakumoto, M., Nishiguchi, K., Nakamura, T., Okamura, N., & Okumura, K. (2006) · Neurologia medico-chirurgica · doi:10.2176/nmc.46.321 · Cited by 20
Human neural stem cell transplant location–dependent neuroprotection and motor deficit amelioration in rats with penetrating traumatic brain injury
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“Unfortunately, many drugs showing significant promise in preclinical studies did not translate through clinical trials to become therapeutics.(8,9) Primary axotomy at the time of the injury triggers self-destructive mechanisms (e.”
Background
Blood-Based Glutamate Scavengers Reverse Traumatic Brain Injury-Induced Synaptic Plasticity Disruption by Decreasing Glutamate Level in Hippocampus Interstitial Fluid, but Not Cerebral Spinal Fluid, In Vivo
Zhang, D., Xiao, M., Wang, L., & Jia, W. (2018) · Neurotoxicity Research · doi:10.1007/s12640-018-9961-8 · Cited by 21
Growth Differentiation Factor 5 Improves Neurogenesis and Functional Recovery in Adult Mouse Hippocampus Following Traumatic Brain Injury
Wu, H., Li, J., Xu, D., Zhang, Q., & Cui, T. (2018) · Frontiers in Neurology · doi:10.3389/fneur.2018.00592 · Cited by 23
“A number of therapeutic strategies have been the focus of extensive preclinical work into the development of neuroprotective and/or neurogenic treatments for secondary brain injury in TBI, but none of them have demonstrated clear benefits in clinical trials (6).”
Background
Traumatic brain injury and palliative care: a retrospective analysis of 49 patients receiving palliative care during 2013–2016 in Turkey
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“However, its global incidence remains unknown (Narayan et al., 2002; Corrigan et al., 2010; Humphreys et al., 2013).”
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Endothelial Nitric Oxide Synthase Mediates the Cerebrovascular Effects of Erythropoietin in Traumatic Brain Injury
Navarro, J. C., Pillai, S. V., Ponce, L. L., Van, M., Goodman, J. C., & Robertson, C. S. (2014) · Frontiers in Immunology · doi:10.3389/fimmu.2014.00494 · Cited by 21
“Despite many promising experimental neuroprotection experiments, there is presently no effective treatment that promotes functional recovery in clinical TBI (2).”
BackgroundSelf-citation
Effects of Magnetically Labeled Exogenous Endothelial Progenitor Cells on Cerebral Blood Perfusion and Microvasculature Alterations after Traumatic Brain Injury in Rat Model
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Structural and functional alterations of cerebellum following fluid percussion injury in rats
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Elf, K., Nilsson, P., & Enblad, P. (2003) · European Journal of Trauma · doi:10.1007/s00068-003-1273-9 · Cited by 19
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“For example, therapy for sequela of traumatic brain injury (TBI) or hemorrhagic shock remains largely supportive.(3,4) Clinical cellular therapeutics (CCTs) like human”
BackgroundSelf-citation
Enduring Neuroprotective Effect of Subacute Neural Stem Cell Transplantation After Penetrating TBI
Kassi, A., Mahavadi, A. K., Clavijo, A., Caliz, D., Lee, S. W., Ahmed, A. I., Yokobori, S., Hu, Z., Spurlock, M. S., Wasserman, J. M., et al. (2019) · Frontiers in Neurology · doi:10.3389/fneur.2018.01097 · Cited by 20
“Promising preclinical results with magnesium blockade of the neuronal NMDA receptor (70), did not translate into neuroprotection in clinical trials, in part due to narrow therapeutic windows, adverse side effects, and interference with normal electrical activity of the brain (11, 19, 90, 137).”
Background
Initial free cortisol dynamics following blunt multiple trauma and traumatic brain injury: A clinical study
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“Secondary damage caused by, for example, impaired blood flow, an affected blood–brain barrier, a deregulated immune system or impaired cellular function, are the focus of ongoing discussions.(2,3) An issue possibly caused by these mechanisms that has attracted increasing attention in the last decade is secondary corti…”
Background
Blockade of N-acetylaspartylglutamate peptidases: a novel protective strategy for brain injuries and neurological disorders
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MRI of Neuronal Recovery after Low-Dose Methamphetamine Treatment of Traumatic Brain Injury in Rats
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“TBI to-date has primarily focused on therapeutic intervention designed to reduce cellular damage and brain edema [9];”
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Cranio-cerebral injuries caused by nail guns: report on two cases, review of the literature and treatment algorithm.
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Design of acute neuroprotection studies
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“It is important to note that blood–brain barrier penetrance of Selfotel was never demonstrated (Narayan et al., 2002).”
BackgroundResultInfluentialSelf-citation
Dynamics of clusterin protein expression in the brain and plasma following experimental traumatic brain injury
Gupta, S. D., Lipponen, A., Paldanius, K. M. A., Puhakka, N., & Pitkänen, A. (2019) · Scientific Reports · doi:10.1038/s41598-019-56683-6 · Cited by 15
Why Does Brain Trauma Research Fail?
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The Effect of Goal-Directed Therapy on Patient Morbidity and Mortality After Traumatic Brain Injury: Results From the Progesterone for the Treatment of Traumatic Brain Injury III Clinical Trial*
Merck, L. H., Yeatts, S. D., Silbergleit, R., Manley, G. T., Pauls, Q., Palesch, Y. Y., CONWIT, R. A., Roux, P. L., Miller, J. B., Frankel, M., et al. (2019) · Critical Care Medicine · doi:10.1097/ccm.0000000000003680 · Cited by 24
Reduced Neuroinflammation and Improved Functional Recovery after Traumatic Brain Injury by Prophylactic Diet Supplementation in Mice
Yu, J., Zhu, H., Taheri, S., Monday, W., Perry, S., & Kindy, M. (2019) · Nutrients · doi:10.3390/nu11020299 · Cited by 17
“While a therapy for this deleterious disorder still remains elusive, there has been a tremendous effort in translational research to understand and manage the clinical symptoms subsequent to TBI [7,8].”
Background
Relative Deficiency of Plasma A Disintegrin and Metalloprotease with Thrombospondin Type 1 Repeats 13 Activity and Elevation of Human Neutrophil Peptides in Patients with Traumatic Brain Injury
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“Admission Glasgow Coma Score (3–8) 17 (53) Hospital length of stay (days) 12 (2-59) Intensive care unit length of stay (days) 10 (2-27)”
Background
Treatment of Traumatic Brain Injury with Vepoloxamer (Purified Poloxamer 188)
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Acute Traumatic Brain Injury: Is Current Management Evidence Based? An Empirical Analysis of Systematic Reviews
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Advances and challenges in experimental models of posttraumatic epilepsy for therapeutic interventions
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“Despite over 20 late-phase clinical trials for moderate/severe TBI, 408,409 these therapies have not demonstrated significant benefits compared to placebos.”
Longitudinal changes in brain parenchyma due to mild traumatic brain injury during the first year after injury
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Histone Deacetylase 4 Downregulation Elicits Post-Traumatic Psychiatric Disorders through Impairment of Neurogenesis
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“Recently, almost all Phase II/III clinical trials with HDACs in neuroprotection have failed to show any consistent improvement in outcome for TBI patients, mostly because of non-specificity of HDAC inhibitors.(97,98) Our study fulfills some of the critical gaps and suggests that induction of HDAC4 instead of downregul…”
Background
Peptide Pharmacological Approaches to Treating Traumatic Brain Injury: a Case for Arginine-Rich Peptides
Chiu, L. S., Anderton, R. S., Knuckey, N. W., & Meloni, B. P. (2016) · Molecular Neurobiology · doi:10.1007/s12035-016-0287-3 · Cited by 14
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Social interaction attenuates the extent of secondary neuronal damage following closed head injury in mice
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“Importantly, 77 (26%) of the 295 head-injured children in our study met one or more potential exclusion criteria for a future trial of TBI therapy.(3,6) Clinical characteristics that would make patients potentially ineligible for a future TBI trial are described in Table 2.”
Background
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Pickard, J. D., Hutchinson, P. J., Coles, J., Steiner, L. A., Johnston, A., Fryer, T. D., Coleman, M. R., Smielewski, P., Chatfield, D., Aigbirhio, F., et al. (2005) · Acta neurochirurgica. Supplement · doi:10.1007/3-211-32318-x_94 · Cited by 16
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Method
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Background
Functional Status Examination Yields Higher Measurement Precision of Functional Limitations after Traumatic Injury than the Glasgow Outcome Scale-Extended: A Preliminary Study
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“FSE overall score Median (IQR) 7 (3–12) 7 (3-12) 6 (4-10) Mean (SD) 7.”
Self-citation
Does magnesium sulfate have a role in the management of severe traumatic brain injury in civilian and military populations? A systematic review and meta-analysis
Lyons, M., & Blackshaw, W. J. (2018) · Journal of the Royal Army Medical Corps · doi:10.1136/jramc-2018-000916 · Cited by 15
Secondary Insults Related to Nursing Interventions in Neurointensive Care: A Descriptive Pilot Study
Nyholm, L., Steffansson, E., Fröjd, C., & Enblad, P. (2014) · Journal of Neuroscience Nursing · doi:10.1097/jnn.0000000000000077 · Cited by 15
“There have been several clinical trials with neuroprotective drugs that have failed (Narayan et al., 2002), and prevention of secondary insults is still a cornerstone in the management of NIC patients.”
Background
The Dig Task: A Simple Scent Discrimination Reveals Deficits Following Frontal Brain Damage
Martens, K. M., Haar, C. V., Hutsell, B. A., & Hoane, M. (2013) · Journal of Visualized Experiments · doi:10.3791/50033 · Cited by 15
Neuroglobin upregulation offers neuroprotection in traumatic brain injury
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Jiang, J.-D., Bu, X.-Y., Liu, M., & Cheng, P.-X. (2012) · Neural Regeneration Research · doi:10.3969/j.issn.1673-5374.2012.01.008 · Cited by 15
“To date, there is no effective method for promoting functional recovery other than routine medical intervention and care([3]).”
Method
Therapeutic Targeting of Astrocytes After Traumatic Brain Injury
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Einfluss des Schädel-Hirn-Traumas auf Zeitpunkt und Technik der Frakturversorgung
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“Although proven effective in many preclinical studies, the use of antioxidants in the management of TBI has failed thus far [ 123 ].”
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A Glutamate N-Methyl-d-Aspartate (NMDA) Receptor Subunit 2B–Selective Inhibitor of NMDA Receptor Function with Enhanced Potency at Acidic pH and Oral Bioavailability for Clinical Use
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“Moreover, the heterogeneous nature of acute brain injury requires careful management of the inclusion criteria, and improved image-based analysis of collateral blood flow and hypoperfusion with comprehensive postinjury analysis could diminish variability (Kidwell et al., 2001; Narayan et al., 2002; Guenego et al., 202…”
Background
Evaluation of Diffusion Tensor Imaging and Fluid Based Biomarkers in a Large Animal Trial of Cyclosporine in Focal Traumatic Brain Injury
Karlsson, M., Yang, Z.-H., Chawla, S., Delso, N., Pukenas, B., Elmér, E., Hugerth, M., Margulies, S., Ehinger, J. K., Hansson, M., et al. (2020) · Journal of Neurotrauma · doi:10.1089/neu.2020.7317 · Cited by 14
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“27 If statin drugs have neuroprotective effects, they would be one of the few strategies likely to be implemented prior to the trauma.”
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Identification of Potentially Neuroprotective Genes Upregulated by Neurotrophin Treatment of CA3 Neurons in the Injured Brain
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“To date, no pharmacotherapy has proven effective in preventing neural cell loss after TBI in human patients (Narayan et al., 2002; Tolias and Bullock, 2004).”
Background
Multicenter Pilot Study: Safety of Automated Chest Percussion in Patients at Risk for Intracranial Hypertension
Olson, D. M., Bader, M., Dennis, C. M., Mahanes, D., & Riemen, K. E. (2010) · Journal of Neuroscience Nursing · doi:10.1097/jnn.0b013e3181d4a3aa · Cited by 13
“…of neurologically injured patients during the early critical phase (the first 1 to 2 weeks immediately after the injury) is not focused on healing the patient but rather on limiting secondary brain injury (Greenberg, 2001; March, 2000; Marion, 2002; Reinert & Bullock, 1999; Yanko & Mitcho, 2001).”
Background
CRASH (Corticosteroid Randomization after Significant Head Injury Trial): landmark and storm warning.
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Hierarchical Polyacrylonitrile-Derived Nitrogen Self-Doped 3D Carbon Superstructures Enabling Electrochemical Detection of Calcium Channel Blocker Nimodipine in Real Human Blood Serum
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The Use of Nicotinamide as a Treatment for Experimental Traumatic Brain Injury and Stroke: A Review and Evaluation
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“In the field of TBI, several promising drugs and therapies have been tested, but currently none have passed clinical trials [28-30].”
Background
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Basic science of closed head injuries and spinal cord injuries
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“In fact, to date no clinical trial investigating a pharmacologic compound for the treatment of TBI has been successful [5–7].”
Background
Critical thresholds of long-pressure reactivity index and impact of intracranial pressure monitoring methods in traumatic brain injury
Hong, E., Froese, L., Pontén, E., Fletcher-Sandersjöö, A., Tatter, C., Hammarlund, E., Åkerlund, C., Tjerkaski, J., Alpkvist, P., Bartek, J., et al. (2024) · Critical Care · doi:10.1186/s13054-024-05042-7 · Cited by 11
“However, despite improvements in monitoring, about 40% of severe TBI patients deteriorate, presumably due to secondary brain injuries caused by a deranged metabolism, inadequate perfusion, and other intracranial insults [4, 5].”
Background
Utilizing novel TBI-on-a-chip device to link physical impacts to neurodegeneration and decipher primary and secondary injury mechanisms
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Developing a National Trauma Research Action Plan: Results from the Neurotrauma Research Panel Delphi Survey
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Self-citation
The ‘Omics’ of Epigenetic Modulation by Valproic Acid Treatment in Traumatic Brain Injury—What We Know and What the Future Holds
Bhatti, U. F., Williams, A. M., Georgoff, P. E., & Alam, H. (2019) · PROTEOMICS - Clinical Applications · doi:10.1002/prca.201900068 · Cited by 11
Stimulation of N-methyl-D-aspartate receptors by exogenous and endogenous ligands improves outcome of brain injury
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“Moreover, blockade of NMDAR at this time interferes with its normal physiological functions, which include promotion of neuronal survival and synaptic transmission and thus may account for the need to prematurely stop some of the clinical trials targeted to block NMDAR [1,2].”
Self-citation
Self-reported competency – validation of the Norwegian version of the patient competency rating scale for traumatic brain injury
Sveen, U., Anđelić, N., Bautz‐Holter, E., & Røe, C. (2014) · Disability and Rehabilitation · doi:10.3109/09638288.2014.913706 · Cited by 13
“The external validity of the PCRS, which was tested against the global functional measure GOSE, showed that all three PCRS subscales correlated moderately with the GOSE.”
BackgroundInfluential
Post-Traumatic Neural Depression and Neurobehavioral Recovery after Brain Injury
Hernández, T. D. (2006) · Journal of Neurotrauma · doi:10.1089/neu.2006.23.1211 · Cited by 11
“Nonetheless, an extensive body of work has accumulated (Narayan et al., 2002; Phillips et al., 2003; Tolias and Bullock, 2004) and therefore laid the essential groundwork for future research to identify and characterize treatments strategies that improve neurobehavioral outcome (Lu et al., 2004).”
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Pediatric Trauma: Pathophysiology, Diagnosis, and Treatment
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Biostatistical Issues in TBI Clinical Trials
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Translational Principles of Neuroprotective and Neurorestorative Therapy Testing in Animal Models of Traumatic Brain Injury
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The Contributing Role of Lipid Peroxidation and Protein Oxidation in the Course of CNS Injury Neurodegeneration and Neuroprotection
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Science and Practice of Pediatric Critical Care Medicine
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“Overall, this breadth amongst the clinical population, with respect to both injury and outcome, is one of the primary contributors to challenges facing clinical trials and preclinical translation (Doppenberg et al. 2004; Howard et al. 2017; McConeghy et al. 2012; Narayan et al. 2002; Stein 2015).”
Current State of Diffusion-Weighted Imaging and Diffusion Tensor Imaging for Traumatic Brain Injury Prognostication
Grant, M., Liu, J., Wintermark, M., Bağcı, U., & Douglas, D. (2023) · Neuroimaging Clinics of North America · doi:10.1016/j.nic.2023.01.004 · Cited by 15
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“Because the impairment of normal cerebrovascular hemodynamics in TBI have serious prognostic implications [29], a GDT approach targeting optimization of cerebral hemodynamics such as the CPP, PbtO2, and ICP—or its noninvasive surrogates—can improve clinical outcomes by preventing the secondary injury cascade [28–31].”
BackgroundInfluential
Understanding the pathology and treatment of traumatic brain injury and posttraumatic stress disorder: a therapeutic role for hyperbaric oxygen therapy
Guedes, V. A., Song, S., Provenzano, M., & Borlongan, C. V. (2015) · Expert Review of Neurotherapeutics · doi:10.1586/14737175.2016.1126180 · Cited by 9
“[1,11,12] To help the clinicians classify TBI cases, different types of neurological severity scales have been developed in which the Glasgow Coma Scale (GCS) is the most widely used because of its high intraobserver reliability and generally good prognostic capabilities.[13] This scale allows the identification of th…”
Background

Authors: Narayan, R. K., Michel, M. E., Ansell, B., Baethmann, A., Biegon, A., Bracken, M. B., Bullock, M. R., Choi, S. C., Clifton, G. L., Contant, C. F., Coplin, W. M., Dietrich, W. D., Ghajar, J., Grady, S. M., Grossman, R. G., Hall, E. D., Heetderks, W., Hovda, D. A., Jallo, J., Katz, R. L., Knoller, N., Kochanek, P. M., Maas, A. I., Majde, J., Marion, D. W., Marmarou, A., Marshall, L. F., McIntosh, T. K., Miller, E., Mohberg, N., Muizelaar, J. P., Pitts, L. H., Quinn, P., Riesenfeld, G., Robertson, C. S., Strauss, K. I., Teasdale, G., Temkin, N., Tuma, R., Wade, C., Walker, M. D., Weinrich, M., Whyte, J., Wilberger, J., Young, A. B., & Yurkewicz, L.
Affiliations: Temple University Hospital (US)
National Institute of Neurological Disorders and Stroke (US)
National Institutes of Health (US)
Ludwig-Maximilians-Universität München (DE)
Lawrence Berkeley National Laboratory (US)
Yale University (US)
Virginia Commonwealth University (US)
The University of Texas Health Science Center at Houston (US)
Baylor College of Medicine (US)
Wayne State University (US)
University of Miami (US)
Brain Trauma Foundation (US)
Hospital of the University of Pennsylvania (US)
Pfizer (United States) (US)
University of California, Los Angeles (US)
Temple University (US)
United States Food and Drug Administration (US)
Sheba Medical Center (IL)
University of Pittsburgh (US)
Academisch Ziekenhuis Rotterdam (NL)
Office of Naval Research (US)
University of California San Diego (US)
University of California Davis Medical Center (US)
University of California, San Francisco (US)
Southern General Hospital (GB)
University of Washington (US)
Allegheny General Hospital (US)
Albert B. Chandler Hospital (US)
ORCID: Narayan, Raj K.
Biegon, Anat
Choi, Sung C.
Dietrich, W. Dalton
Grady, Sean M.
Grossman, Robert G.
Heetderks, William
Jallo, Jack
Kochanek, Patrick M.
Maas, Andrew I.
Marion, Donald W.
McIntosh, Tracy K.
Robertson, Claudia S.
Temkin, Nancy
Wade, Charles
Walker, Michael D.
Weinrich, Michael
Whyte, John
Venue: Journal of Neurotrauma
Publisher: SAGE Publications
Published: 2002-05
Volume: 19
Issue: 5
Pages: 503-557
ISSN: 0897-7151 (ISSN-L)
1557-9042
DOI: 10.1089/089771502753754037
PMC: PMC1462953
OpenAlex: W2045663952
Cited by: 913
References: 0
Citations by year: 2026: 11 · 2025: 16 · 2024: 20 · 2023: 14 · 2022: 15 · 2021: 20 · 2020: 35 · 2019: 43 · 2018: 43 · 2017: 40 · 2016: 42 · 2015: 55 · 2014: 49 · 2013: 56 · 2012: 61
FWCI: 20.60
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Licence: www.liebertpub.com/nv/resources-tools/text-and-data-mining-policy/121/ (tdm)
Locations: Journal of Neurotrauma (publishedVersion)
PubMed (publishedVersion)
EUR Research Repository (Erasmus University Rotterdam) (publishedVersion)
PubMed Central (acceptedVersion)
Deep Blue (University of Michigan) (submittedVersion, public-domain)
EUR Research Repository (Erasmus University Rotterdam) (submittedVersion)
Funders: National Institutes of Health (7r01ns038654-04)
National Institute of Neurological Disorders and Stroke (R01-NS038654)
Topics: Health Sciences › Medicine › Clinical Neurology › Traumatic Brain Injury and Neurovascular Disturbances
Health Sciences › Medicine › Clinical Neurology › Traumatic Brain Injury Research
Physical Sciences › Engineering › Biomedical Engineering › Automotive and Human Injury Biomechanics
Keywords: traumatic brain injury, clinical trial design, closed head injury, penetrating head injury, translational research, treatment failure, long-term disability
MeSH terms: Brain Injuries, Clinical Trials as Topic, Humans

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