Abstract
Background
Over the past 30 years, there have been significant advances in the understanding of the mechanisms associated with loss and recovery of consciousness following severe brain injury. This work has provided a strong grounding for the development of novel restorative therapeutic interventions. Although all interventions are aimed at modulating and thereby restoring brain function, the landscape of existing interventions encompasses a very wide scope of techniques and protocols. Despite vigorous research efforts, few approaches have been assessed with rigorous, high-quality randomized controlled trials. As a growing number of exploratory interventions emerge, it is paramount to develop standardized approaches to reporting results. The successful evaluation of novel interventions depends on implementation of shared nomenclature and infrastructure. To address this gap, the Neurocritical Care Society’s Curing Coma Campaign convened nine working groups and charged them with developing common data elements (CDEs). Here, we report the work of the Therapeutic Interventions Working Group.
Methods
The working group reviewed existing CDEs relevant to therapeutic interventions within the National Institutes of Health National Institute of Neurological Disorders and Stroke database and reviewed the literature for assessing key areas of research in the intervention space. CDEs were then proposed, iteratively discussed and reviewed, classified, and organized in a case report form (CRF).
Results
We developed a unified CRF, including CDEs and key design elements (i.e., methodological or protocol parameters), divided into five sections: (1) patient information, (2) general study information, (3) behavioral interventions, (4) pharmacological interventions, and (5) device interventions.
Conclusions
The newly created CRF enhances systematization of future work by proposing a portfolio of measures that should be collected in the development and implementation of studies assessing novel interventions intended to increase the level of consciousness or rate of recovery of consciousness in patients with disorders of consciousness.
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Acknowledgements
The Curing Coma Campaign collaborators are listed. Venkatesh Aiyagari, Yama Akbari, Fawaz Al-Mufti, Sheila Alexander, Anne Alexandrov, Ayham Alkhachroum, Moshagan Amiri, Brian Appavu, Meron Awraris Gebre, Mary Kay Bader, Neeraj Badjiata, Ram Balu, Megan Barra, Rachel Beekman, Ettore Beghi, Kathleen Bell, Erta Beqiri, Tracey Berlin, Thomas Bleck, Yelena Bodien, Varina Boerwinkle, Melanie Boly, Alexandra Bonnel, Emery Brown, Eder Caceres, Elizabeth Carroll, Emilio G. Cediel, Sherry Chou, Giuseppe Citerio, Jan Classen, Chad Condie, Katie Cosmas, Claire Creutzfeldt, Neha Dangayach, Michael DeGeorgia, Caroline Der-Nigoghoss, Masoom Desai, Michael Diringer, James Dullaway, Brian Edlow, Ari Ercole, Anna Estraneo, Guido Falcone, Llewellyn Padayachy, Soojin Park, Melissa Pergakis, Len Polizzotto, Nader Pouratian, Marilyn Price Spivack, Lara Prisco, Javier Provencio, Louis Puybasset, Lindsay Rasmussen, Verena Rass, Risa Richardson, Cassia Righy Shinots, Chiara Robba, Courtney Robertson, Benjamin Rohaut, John Rolston, Mario Rosanova, Eric Rosenthal, Mary Beth Russell, Gisele Sampaio Silva, Leandro Sanz, Simone Sarasso, Aarti Sarwal, Nicolas Schiff, Caroline Schnakers, David Seder, Vishank Ar Shah, Amy Shapiro-Rosen, Angela Shapshak, Kartavya Sharma, Tarek Sharshar, Lori Shutter, Jacobo Sitt, Beth Slomine, Peter Smielewski, Wade Smith, Emmanuel Stamatakis, Alexis Steinberg, Salia Farrokh, Simona Ferioli, Davinia Fernandez-Esp, Ericka Fink, Joseph Fins, Brandon Foreman, Jennifer Frontera, Rishi Ganesan, Ahmeneh Ghavam, Joseph Giacino, Christie Gibbons, Emily Gilmore, Olivia Gosseries, Theresa Green, David Greer, Mary Guanci, Cecil Hahn, Ryan Hakimi, Daniel F Hanley, Jed Hartings, Ahmed Hassan, Claude Hemphill, Holly Hinson, Karen Hirsch, Sarah Hocker, Peter Hu, Xiao Hu, Theresa Human, David Hwang, Judy Illes, Matthew Jaffa, Michael L. James, Anna Janas, Morgan Jones, Emanuela Keller, Maggie Keogh, Jenn Kim, Keri Kim, Hannah Kirsch, Matt Kirschen, Nerissa Ko, Daniel Kondziella, Natalie Kreitzer, Robert Stevens, Jose Suarez, Bethany Sussman, Shaurya Taran, Aurore Thibaut, Zachary Threlkeld, Lorenzo Tinti, Daniel Toker, Michel Torbey, Stephen Trevick, Alexis Turgeon, Andrew Udy, Panos Varelas, Chethan Venkatasubba, Paul Vespa, Walter Videtta, Henning Voss, Ford Vox, Amy Wagner, Mark Wainwright, John Whyte, Briana Witherspoon, Aleksandra Yakhind, Ross Zafonte, Darin Zahuranec, Chris Zammit, Bei Zhang, Wendy Ziai, Lara Zimmerman, Elizabeth Zink, Julie Kromm, Abhay Kumar, Pedro Kurtz, Steven Laureys, Thomas Lawson, Nicolas Lejeune, Ariane Lewis, John Liang, Geoffrey Ling, Sarah Livesay, Andrea Luppi, Lori Madden, Craig Maddux, Dea Mahanes, Shraddha Mainali, Nelson Maldonado, Rennan Martins Ribeiro, Marcello Massimini, Stephan Mayer, Victoria McCredie, Molly McNett, Jorge Mejia-Mantill, David Menon, Geert Meyfroidt, Julio Mijangos, Dick Moberg, Asma Moheet, Erika Molteni, Martin Monti, Chris Morrison, Susanne Muehlschlegel, Brooke Murtaugh, Lionel Naccache, Masao Nagayama, Emerson Nairon, Girija Natarajan, Virginia Newcombe, Niklas Nielsen, Filipa Noronha-Falc‹, Paul Nyquist, DaiWai Olson, Marwan Othman, Adrian Owen.
Funding
This work was supported by the Tiny Blue Dot Foundation, the National Institutes of Health National Institute of General Medical Sciences (5R01GM135420), the National Institutes of Health National Institute of General Medical Sciences (5T32GM008042), and Medical Research Council UK (MR/R016372/1).
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All authors contributed to the initial draft of the manuscript, edited the manuscript, and approved the final content. All co-authors contributed equally to the case report forms released with the article.
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NMS receives consulting honoraria from BrainSonix Corp.
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Monti, M.M., Beekman, R., Spivak, N.M. et al. Common Data Element for Disorders of Consciousness: Recommendations from the Working Group on Therapeutic Interventions. Neurocrit Care 40, 51–57 (2024). https://doi.org/10.1007/s12028-023-01873-4
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DOI: https://doi.org/10.1007/s12028-023-01873-4