The minimally conscious state: an analysis of current clinical trials registered in ClinicalTrials.gov
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.
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.Attached Files
Published - APM-22-133-final.pdf
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Additional details
- Eprint ID
- 116054
- Resolver ID
- CaltechAUTHORS:20220802-839173000
- Created
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2022-08-03Created from EPrint's datestamp field
- Updated
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2022-08-03Created from EPrint's last_modified field