Academic Journal
Brain-computer interface clinical trial design considerations and clinical outcome assessments in pivotal studies: a summary of the 11th BCI society meeting 2025 workshop.
| Τίτλος: | Brain-computer interface clinical trial design considerations and clinical outcome assessments in pivotal studies: a summary of the 11th BCI society meeting 2025 workshop. |
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| Συγγραφείς: | Sawyer A; Icahn School of Medicine at Mount Sinai, New York, NY, United States of America., Welle CG; Department of Neurosurgery, University of Colorado, Aurora, CO, United States of America., French J; Neurotech Network, St. Petersburg, FL, United States of America.; Implantable Brain-Computer Interface Collaborative Community (iBCI-CC) Mass General Brigham, Boston, MA, United States of America., Kelemen J; Implantable Brain-Computer Interface Collaborative Community (iBCI-CC) Mass General Brigham, Boston, MA, United States of America., Bashford L; Faculty of Medical Sciences, Newcastle University, Newcastle, United Kingdom., Kramer D; Department of Neurosurgery, University of Colorado, Aurora, CO, United States of America., McMullen D; Neuralink, Fremont, CA, United States of America., Franklin R; Blackrock Neurotech, Salt Lake City, UT, United States of America., Angle MR; Paradromics, Austin, TX, United States of America., Herrmann D; Neuralink, Fremont, CA, United States of America., Oxley T; Synchron Inc, New York, NY, United States of America., Dister J; Precision Neuroscience, New York, NY, United States of America., Chetty N; Department of Mechanical Engineering, Carnegie Mellon University, Pittsburgh, PA, United States of America., Radcliffe EM; Departments of Neurosurgery and Bioengineering, University of Colorado Anschutz Medical Campus, Aurora, CO, United States of America., Kowalczyk J; Faculty of Medical Sciences, Newcastle University, Newcastle, United Kingdom., Bose R; Case Western Reserve University, Cleveland, OH, United States of America., Farooqui J; University of Pennsylvania, Philadelphia, PA, United States of America., Hochberg LR; Implantable Brain-Computer Interface Collaborative Community (iBCI-CC) Mass General Brigham, Boston, MA, United States of America.; Center for Neurotechnology and Neurorecovery, Department of Neurology, Neuroscience Institute, Mass General Brigham, Harvard Medical School, Boston, MA, United States of America.; VA Center for Neurorestoration and Neurotechnology, VA Providence Healthcare, Providence, RI, United States of America.; School of Engineering and Carney Institute for Brain Science, Brown University, Providence, RI, United States of America. |
| Πηγή: | Journal of neural engineering [J Neural Eng] 2026 Sep 11; Vol. 23 (5). Date of Electronic Publication: 2026 Sep 11. |
| Τύπος έκδοσης: | Journal Article |
| Γλώσσα: | English |
| Στοιχεία περιοδικού: | Publisher: Institute of Physics Pub Country of Publication: England NLM ID: 101217933 Publication Model: Electronic Cited Medium: Internet ISSN: 1741-2552 (Electronic) Linking ISSN: 17412552 NLM ISO Abbreviation: J Neural Eng Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: Bristol, U.K. : Institute of Physics Pub., 2004- |
| Ιατρικοί όροι (MeSH): | Clinical Trials as Topic*/methods , Clinical Trials as Topic*/standards , Outcome Assessment, Health Care*/methods , Education*/trends , Education*/methods , Brain-Computer Interfaces* , Research Design*, Humans |
| Περίληψη: | Objective.The Brain Computer Interface (BCI) Society Meeting 2025 held a workshop in collaboration with the Implantable BCI Collaborative Community (iBCI-CC) to discuss the selection, development and validation of clinical trial outcome assessments (COAs) for pivotal studies of BCIs. The iBCI-CC Clinical Study Endpoints Workgroup aims to build consensus on a COA framework that can meet the demands of emerging iBCI trials.Approach.The workshop brought together diverse stakeholders from the iBCI-CC community and beyond, including industry, academic and government institutions to engage in pre-competitive collaborative discussion.Main results.Through presentations, panel discussions and breakout groups, workshop participants highlighted meaningful aspects of health (MAHs) relevant to iBCI users, clarified the need to define corresponding concepts of interest (COIs) and to identify or adapt COAs capable of capturing both functional impact and real-world use. Key challenges highlighted during the workshop are patient heterogeneity, the lack of widely validated and fit-for-purpose COAs, and the need to capture meaningful outcomes in home and daily-life environments. Lessons drawn from trials such as ADAPT-PD underscore the value of capturing device performance in home and daily-life settings, highlighting the need for context-sensitive and flexible metrics that reflect patient priorities.Significance.This workshop lays a foundation for the iBCI-CC Clinical Study Endpoints Workgroup to establish a transparent process for identifying MAHs and COIs that are suitable for specific iBCI technologies, patient-informed, and conducive to regulatory approval and reimbursement. By combining rigorous, quantitative assessment with patient-informed goals, iBCI clinical trials can advance toward safe, effective, and accessible neurotechnologies that enhance how a person with a severe motor impairment feels, functions and survives. (Creative Commons Attribution license.) |
| Contributed Indexing: | Keywords: brain computer interface; clinical endpoints; medical devices; outcome measures |
| Entry Date(s): | Date Created: 20260826 Date Completed: 20260911 Latest Revision: 20260911 |
| Update Code: | 20260911 |
| DOI: | 10.1088/1741-2552/ae9eee |
| PMID: | 42648341 |
| Βάση Δεδομένων: | MEDLINE |
| ISSN: | 1741-2552 |
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| DOI: | 10.1088/1741-2552/ae9eee |