BCIwiki (bciwiki.com) — Choosing the right outcome measures for brain-computer interface (BCI) clinical trials is becoming a key step toward regulatory approval and reimbursement. The 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 outcome assessments (COAs) for pivotal studies of BCIs, summarized in the Journal of Neural Engineering on August 26, 2026.
The workshop centered on challenges such as 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. Participants noted that trials like 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. The workshop lays a foundation for the iBCI-CC Clinical Study Endpoints Workgroup to establish a transparent process for identifying meaningful aspects of health (MAHs) and concepts of interest (COIs) that are suitable for specific iBCI technologies, patient-informed, and conducive to regulatory approval and reimbursement.