Brain-computer interface clinical trial design considerations and clinical outcome assessments in pivotal studies
Workgroups: Clinical Study Endpoints
Date Updated: 11 September 2026
Authors: Abbey Sawyer, Cristin G. Welle, Jennifer French, Jessica Kelemen, Luke Bashford, Daniel R. Kramer, David McMullen, Robert Franklin, Matthew R. Angle, Dustin Herrmann, Thomas Oxley, Jacqueline Dister, Nikole Chetty, Erin M. Radcliffe, Jakub Kowalczyk, Rohit Bose, Juhi Farooqui, & Leigh R. Hochberg
Overview:
This peer-reviewed workshop paper examines clinical trial design considerations and clinical outcome assessments for pivotal brain-computer interface studies.
The 11th BCI Society Meeting 2025 workshop, held in collaboration with the iBCI-CC, brought together stakeholders from industry, academia, government, and the broader BCI community. Participants considered how pivotal iBCI studies can identify meaningful aspects of health, define corresponding concepts of interest, and select or adapt clinical outcome assessments that capture both functional impact and real-world use. The paper describes challenges including patient heterogeneity, the limited availability of widely validated and fit-for-purpose assessments, and the need to measure outcomes in home and daily-life environments. It lays the groundwork for a transparent and patient-informed MAH–COI–COA framework that can support clinical development, regulatory evaluation, and reimbursement.
Audience and Application:
iBCI investigators, clinical trial sponsors, clinicians, people with lived experience and participant advocates, clinical outcome assessment researchers, industry, regulators, payors, and ethics researchers
Application:
This paper can help teams planning pivotal iBCI studies consider how outcomes should be connected to a technology’s intended use, target population, and patient priorities. It provides a foundation for identifying meaningful aspects of health and concepts of interest before selecting or adapting fit-for-purpose clinical outcome assessments. The paper is not a prescriptive regulatory standard; rather, it supports continued pre-competitive collaboration and development of a transparent framework for evidence generation across the iBCI field.
