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AI-driven brain-computed interfaces aimed at restoring speech for individuals living with locked-in-syndrome are paired with ethical implications for user’s autonomy, privacy and responsibility. Embedding options for sufficient levels of user-control in speech-BCI design has been proposed to mitigate these ethical challenges. However, how user-control in speech-BCIs is conceptualized and how it relates to these ethical challenges is underdetermined. In this narrative literature review, we aim to clarify and explicate the notion of user-control in speech-BCIs, to better understand in what way user-control could operationalize user’s autonomy, privacy and responsibility and explore how such suggestions for increasing user-control can be translated to recommendations for the design or use of speech-BCIs. First, we identified types of user control, including executory control that can protect voluntariness of speech, and guidance control that can contribute to semantic accuracy. Second, we identified potential causes for a loss of user-control, including contributions of predictive language models, a lack of ability for neural control, or signal interference and external control. Such a loss of user control may have implications for semantic accuracy and mental privacy. Third we explored ways to design for user-control. While embedding initiation signals for users may increase executory control, they may conflict with other aims such as speed and continuity of speech. Design mechanisms for guidance control remain largely conceptual, similar trade-offs in design may be expected. We argue that preceding these trade-offs, the overarching aim of speech-BCIs needs to be defined, requiring input from current and potential users. Additionally, conceptual clarification of user-control and other (ethical) concepts in this debate has practical relevance for BCI researchers. For instance, different concepts of inner speech may have distinct ethical implications. Increased clarity of such concepts can improve anticipation of ethical implications of speech-BCIs and may help to steer design decisions.

Abstract Background Stereotactic radiosurgery (SRS) is a frequently chosen treatment for patients with brain metastases and the number of long-term survivors is increasing. Brain necrosis (e.g. radionecrosis) is the most important long-term side effect of the treatment. Retrospective studies show a lower risk of radionecrosis and local tumor recurrence after fractionated stereotactic radiosurgery (fSRS, e.g. five fractions) compared with stereotactic radiosurgery in one or three fractions. This is especially true for patients with large brain metastases. As such, the 2022 ASTRO guideline of radiotherapy for brain metastases recommends more research to fSRS to reduce the risk of radionecrosis. This multicenter prospective randomized study aims to determine whether the incidence of adverse local events (either local failure or radionecrosis) can be reduced using fSRS versus SRS in one or three fractions in patients with brain metastases. Methods Patients are eligible with one or more brain metastases from a solid primary tumor, age of 18 years or older, and a Karnofsky Performance Status ≥ 70. Exclusion criteria include patients with small cell lung cancer, germinoma or lymphoma, leptomeningeal metastases, a contraindication for MRI, prior inclusion in this study, prior surgery for brain metastases, prior radiotherapy for the same brain metastases (in-field re-irradiation). Participants will be randomized between SRS with a dose of 15–24 Gy in 1 or 3 fractions (standard arm) or fSRS 35 Gy in five fractions (experimental arm). The primary endpoint is the incidence of a local adverse event (local tumor failure or radionecrosis identified on MRI scans) at two years after treatment. Secondary endpoints are salvage treatment and the use of corticosteroids, bevacizumab, or antiepileptic drugs, survival, distant brain recurrences, toxicity, and quality of life. Discussion Currently, limiting the risk of adverse events such as radionecrosis is a major challenge in the treatment of brain metastases. fSRS potentially reduces this risk of radionecrosis and local tumor failure. Trial registration ClincalTrials.gov, trial registration number: NCT05346367 , trial registration date: 26 April 2022.