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The minimally conscious state: an analysis of current clinical trials registered in ClinicalTrials.gov

Produturi, Gautam R. and Kurtz, Joshua S. and Brown, Nolan J. and Choi, Ashley E. and Ibrahim, Lina I. and Gendreau, Julian and Shahrestani, Shane and Sahyouni, Ronald and Castellanos, Joel and Abraham, Mickey E. (2022) The minimally conscious state: an analysis of current clinical trials registered in ClinicalTrials.gov. Annals of Palliative Medicine, 11 (6). pp. 2131-2138. ISSN 2224-5820. doi:10.21037/apm-22-133. https://resolver.caltech.edu/CaltechAUTHORS:20220802-839173000

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Abstract

The minimally conscious state (MCS) is a disorder of consciousness described in recent years for patients who have behavioral responses to stimuli that do not meet the classification of chronic vegetative state (CVS) or coma. This distinction is valuable in clinical practice, as minimally conscious patients may require different treatments and may have different long-term outcomes when compared to vegetative states or coma. In this report, we analyzed the ClinicalTrials.gov database to systematically assess all clinical trials regarding MCS. The database was queried using the term “minimally conscious state” in the “condition or disease” search parameter. Of the studies identified, those that had suspended, terminated, or otherwise unknown statuses were excluded. In total, 41 studies were analyzed. The included studies were initiated between 2008 and 2020, with the majority (63%) beginning in 2015 or later. Of the primary intervention modalities included, 15 (37%) evaluated stimulation modalities such as transcranial magnetic stimulation, transcranial direct current stimulation, implantable neurostimulation, vagus nerve stimulation, focused ultrasound and median nerve stimulation. Additionally, 5 (12%) used some form of behavioral therapy. A total of 4 (10%) studies involved pharmaceutical intervention, including dopamine agonists, analgesics and sedatives. Finally, 4 (10%) studies sought to determine the validity of current diagnostic methods and systems used to assess the status of patients in MCSs. Since the definition and criteria for CVS and MCS have been established, these two conditions remain closely associated despite evidence of different patient outcomes and treatment options. Many clinical trials are underway assessing interventions with stimulation. However, the trials are lacking with respect to diagnostic methods and pharmaceutical treatment.


Item Type:Article
Related URLs:
URLURL TypeDescription
https://doi.org/10.21037/apm-22-133DOIArticle
ORCID:
AuthorORCID
Brown, Nolan J.0000-0002-6025-346X
Gendreau, Julian0000-0001-8412-0437
Shahrestani, Shane0000-0001-7561-4590
Sahyouni, Ronald0000-0002-2124-0535
Additional Information:Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0). Submitted Jan 26, 2022. Accepted for publication Mar 25, 2022. The authors would like to thank the United States National Library of Medicine for maintaining and providing access to the ClinicalTrials.gov database. Funding: None. Contributions: (I) Conception and design: ME Abraham; (II) Administrative support: None; (III) Provision of study materials or patients: None; (IV) Collection and assembly of data: AE Choi, LI Ibrahim; (V) Data analysis and interpretation: GR Produturi, JS Kurtz, NJ Brown; (VI) Manuscript writing: All authors; (VII) Final approval of manuscript: All authors. Peer Review File: Available at https://apm.amegroups.com/article/view/10.21037/apm-22-133/prf. Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://apm.amegroups.com/article/view/10.21037/apm-22-133/coif). The authors have no conflicts of interest to declare. Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Subject Keywords:Clinical trials; Coma Recovery Scale-Revised (CRS-R); minimally conscious state (MCS); transcranial direct stimulation
Issue or Number:6
DOI:10.21037/apm-22-133
Record Number:CaltechAUTHORS:20220802-839173000
Persistent URL:https://resolver.caltech.edu/CaltechAUTHORS:20220802-839173000
Official Citation:Produturi GR, Kurtz JS, Brown NJ, Choi AE, Ibrahim LI, Gendreau J, Shahrestani S, Sahyouni R, Castellanos J, Abraham ME. The minimally conscious state: an analysis of current clinical trials registered in ClinicalTrials.gov. Ann Palliat Med 2022;11(6):2131-2138. doi: 10.21037/apm-22-133
Usage Policy:No commercial reproduction, distribution, display or performance rights in this work are provided.
ID Code:116054
Collection:CaltechAUTHORS
Deposited By: George Porter
Deposited On:03 Aug 2022 15:54
Last Modified:03 Aug 2022 15:54

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