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

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Clinical Trials in Head Injury

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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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Johnson, B. D., Dodd, A. B., Mayer, A. R., Hallett, M., & Slobounov, S. (2018) · Brain Imaging and Behavior · doi:10.1007/s11682-018-9982-1 · Cited by 7
“2017), and is essential for the discovery of potential treatments(Doppenberg et al. 2004; Marshall 2000; Narayan et al. 2002).”
Background
Detection of Impaired Cerebral Autoregulation Using Selected Correlation Analysis: A Validation Study
Proescholdt, M., Faltermeier, R., Bele, S., & Brawanski, A. (2017) · Comput. Math. Methods Medicine · doi:10.1155/2017/8454527 · Cited by 5
“Neuroprotection after catastrophic CNS events as a causal treatment has been the primary goal of neuroscientific research in the field; however so far clinical trials have not yielded any significant success in patients with either SAH or TBI [21, 22].”
Parameter Optimization for Selected Correlation Analysis of Intracranial Pathophysiology
Faltermeier, R., Proescholdt, M., Bele, S., & Brawanski, A. (2015) · Comput. Math. Methods Medicine · doi:10.1155/2015/652030 · Cited by 5
“prospectively evaluating new therapeutic approaches have invariably failed to demonstrate any significant improvement of outcome [22, 23].”
Background
Clinical syndromes of neurotransmitter system dysfunction in severe brain injury
Александрова, Е. В., Zaytsev, O. S., & Aa, P. (2015) · S S Korsakov Journal of Neurology and Psychiatry · doi:10.17116/jnevro20151157140-46 · Cited by 5
Stroke and Traumatic Brain Injury
Lerouet, D., Besson, V. C., & Plotkine, M. (2014) · Methods and principles in medicinal chemistry · doi:10.1002/9783527679348.ch17 · Cited by 5
The RESCUEicp study of decompressive craniectomy: Implications for practice
Corteen, E., Timofeev, I., Kirkpatrick, P., & Hutchinson, P. (2007) · doi:10.12968/bjnn.2007.3.9.27137 · Cited by 5
Neuronal injury and neuroprotection
Menon, D., & Wheeler, D. (2005) · doi:10.1383/anes.6.6.184.65786 · Cited by 5
Therapie des Schädel-Hirn-Traumas
Unterberg, A., Sarrafzadeh, A., & Kiening, K. (2003) · doi:10.1055/s-2003-37567 · Cited by 5
Chapter 5 – Traumatic Brain Injury
Chakraborty, S., Skolnick, B., Alves, W., Marshall, L., & Narayan, R. (2018) · Elsevier eBooks · doi:10.1016/b978-0-12-804064-5.00005-9 · Cited by 5
Self-citation
E-infrastructures fostering multi-centre collaborative research into the intensive care management of patients with brain injury
Sinnott, R., & Piper, I. (2009) · IGI Global eBooks · doi:10.4018/978-1-60566-374-6.ch025 · Cited by 5
“these agents have failed to show any significant improvement in patient outcome (Narayan 2002).”
Background
Traumatic brain injury. Rethinking pharmacological clinical trials in an orphan pathology
Imberti, R. (2025) · Expert Review of Clinical Pharmacology · doi:10.1080/17512433.2025.2546148 · Cited by 4
“Based on prior research [2,18,28], a 4% reduction in unfavorable outcomes – from 50% to 46%, which equates to an 8% relative reduction – can be considered both apparently reasonable and clinically significant.”
Metabolic and endocrine dysfunctions in traumatic brain injury: Implications for cognitive recovery and therapeutic strategies
Haria, J., Singh, N. K., Kumar, J., Jain, S. K., & Pamidimarri, D. (2025) · Behavioural Brain Research · doi:10.1016/j.bbr.2025.115697 · Cited by 5
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Prophylactic treatment with CN-105 improves functional outcomes in a murine model of closed head injury
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“Although many interventions have been evaluated for this purpose, over 30 phase III prospective clinical trials evaluating various therapies have failed to reach their primary endpoints (Narayan et al. 2002; Schouten 2007; Maas et al. 2010; Chakraborty et al. 2016; Loane et al. 2015; Davenport 2016).”
Background
EphB3 interacts with initiator caspases and FHL-2 to activate dependence receptor cell death in oligodendrocytes after brain injury
Tsenkina, Y., Tapanes, S. A., Díaz, M. M., Titus, D. J., Gajavelli, S., Bullock, R. M., Atkins, C. M., & Liebl, D. J. (2020) · Brain Communications · doi:10.1093/braincomms/fcaa175 · Cited by 5
“Unfortunately, clinical trials targeting members of this family have been largely unsuccessful (Shohami et al., 1999; Narayan et al., 2002; Xiong et al., 2009; Loane and Faden, 2010; Kabadi and Faden, 2014).”
Background
Best Practices for Obtaining Genomic Consent in Pediatric Traumatic Brain Injury Research
Schnur, K., Gill, E., Guerrero, A., Osier, N., & Reuter-Rice, K. (2019) · Nursing Research · doi:10.1097/nnr.0000000000000335 · Cited by 4
“Despite the high incidence and increasing rates of TBI and its substantial effect on health outcomes and quality of life, there is no Food and Drug Administration-approved treatment for TBI in children or adults (Narayan et al., 2002; Stanley et al., 2012).”
Therapeutic Hypothermia in Children and Adults with Severe Traumatic Brain Injury
Sandestig, A., Romner, B., & Grände, P. (2014) · Therapeutic Hypothermia and Temperature Management · doi:10.1089/ther.2013.0024 · Cited by 4
“…antagonists, magnesium sulfate, and scavenging agents, have been analyzed in randomized trials in TBI patients, but none of these potential neuroprotective substances have been shown to be beneﬁcial (Marshall, 2000; Narayan et al. , 2002; Maas et al. , 2006; Temkin et al. , 2007; Lu et al. , 2012).”
Closed head injury.
Lin, J.-C., Liu, T.-J., Hsu, S.-W., Tseng, K.-Y., Tsai, T.-H., Ma, H.-I., & Hueng, D.-Y. (2013) · Journal of Neurosurgery · doi:10.3171/2013.4.jns13807 · Cited by 4
Современные методы лечения ушибов головного мозга
Talypov, A. E., Petrikov, S. S., Puras, Y. V., Solodov, A. A., & Titova, Y. V. (2011) · Neurology, neuropsychiatry, Psychosomatics · doi:10.14412/2074-2711-2011-127 · Cited by 4
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Stratégies anti-inflammatoires et traumatisme crânien☆
Lescot, T., Marchand-Verrecchia, C., & Puybasset, L. (2006) · doi:10.1016/j.annfar.2006.03.014 · Cited by 4
Ethical and regulatory considerations in the design of traumatic brain injury clinical studies
Hicks, R. R. (2015) · Handbook of clinical neurology · doi:10.1016/b978-0-444-63521-1.00046-7 · Cited by 7
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Betrus, C., & Kreipke, C. W. (2012) · Springer eBooks · doi:10.1007/978-1-4614-4148-9_1 · Cited by 2
A Wireless Battery-Free Cerebral-Oxygen-Monitoring Micro-System Featuring 0.21-mmHg Sensing Resolution
Wang, W.-X., Zhu, B., Xuan, Y., Shen, Y.-L., Xiao, Q.-J., Wang, Z.-Y., Luo, Y., Pan, G., Su, B., & Zhao, B. (2025) · IEEE Journal of Solid-State Circuits · doi:10.1109/jssc.2025.3577123 · Cited by 3
“As a result, the COM technique provides insight into the severity of injuries during invasive TBI medical treatment [4].”
Practical pearls for management of cranial injury in the developing world
Detchou, D. K. E., Darko, K., & Barrie, U. (2024) · Neurosurgical review · doi:10.1007/s10143-024-02822-1 · Cited by 3
Diacylglycerol Lipase-β Knockout Mice Display a Sex-Dependent Attenuation of Traumatic Brain Injury-Induced Mortality with No Impact on Memory or Other Functional Consequences
Schurman, L. D., Smith, T. L., Donvito, G., Cravatt, B. F., Newton, J. C., Spiegel, S., Reeves, T. M., Phillips, L. L., & Lichtman, A. H. (2021) · Cannabis and Cannabinoid Research · doi:10.1089/can.2020.0175 · Cited by 3
“51,52 59 The mixed results of anti-inﬂammatory drug targets in preclinical research and the failed translation to clinical learning and memory protection is perhaps a consequence of the limitations of animal models as well as the necessity to promote the beneﬁcial effects of acute neuroinﬂammation,…”
Neuroprotective Effects of Polyphenols in Aging and Age‐Related Neurological Disorders
Corona, G., & Vauzour, D. (2017) · Wiley eBooks · doi:10.1002/9781119155195.ch3 · Cited by 5
Non-mammalian Animal Models Offer New Perspectives on the Treatment of TBI
Ganetzky, B., & Wassarman, D. (2016) · Current Physical Medicine and Rehabilitation Reports · doi:10.1007/s40141-016-0107-8 · Cited by 3
Diagnostische Biomarker des Schädel-Hirn-Traumas
Wanke-Jellinek, L., van Griensven, M., & Biberthaler, P. (2014) · Der Unfallchirurg · doi:10.1007/s00113-013-2542-7 · Cited by 2
Only repeated administration of the serotonergic agonist 8-OH-DPAT improves place learning of rats subjected to fimbria-fornix transection
Rytter, H. M., Arnberg, K., Chu, D., Nedergaard, S., Witmer, J., & Mogensen, J. (2013) · Pharmacology Biochemistry and Behavior · doi:10.1016/j.pbb.2013.05.008 · Cited by 4
Current Opinions on Epidemiology, Treatment and Outcome After Traumatic Brain Injury
Urbanek, F., Frink, M., Grün, O., & Lohse, R. (2012) · Journal of Trauma & Treatment · doi:10.4172/2167-1222.1000s1-001 · Cited by 3
“During resuscitation or clinical course so-called “secondary brain injuries” might occur [45,46] increasing the risk of an unfavourable outcome: The development is based upon the known inflammatory response to trauma with free radical and calcium mediated cell necrosis and astrocytic swelling caused by neurotransmitte…”
Background
Carotid Disease and Stroke
Lovrenčić-Huzjan, A., Rundek, T., & Katsnelson, M. J. (2012) · Stroke Research and Treatment · doi:10.1155/2012/264752 · Cited by 3
Severe disability.
Imberti, R. (2012) · Journal of Neurosurgery · doi:10.3171/2011.8.jns11880 · Cited by 3
Traumatic Brain Injury: Current Management, Controversies, and Clinical Trials
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“In May 2000, the National Institute of Neurological Disorders and Stroke sponsored a workshop that brought together leading TBI experts in an effort to identify means of improving trial design.(124) Interest in the development of neuroprotective agents has not waned and newer trials have incorporated many of those lea…”
BackgroundInfluentialSelf-citation
Traumatic brain injuries.
Duhaime, A. (2011) · Journal of Neurosurgery · doi:10.3171/2010.4.jns10409 · Cited by 3
The Effect of Reductive Ventricular Osmotherapy on the Osmolarity of Artificial Cerebrospinal Fluid and the Water Content of Cerebral Tissue Ex Vivo
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Metabolic effects of a late hypotensive insult combined with reduced intracranial compliance following traumatic brain injury in the rat
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Self-citation

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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