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A new generation of implantable brain–computer interfaces (BCI) devices have been tested for the first time in a human clinical trial, with significant success. These intelligent implants detect specific neuronal activity patterns, such as an epileptic seizure, and provide information to help patients to respond to the upcoming neuronal events. By forecasting a seizure, the technology keeps patients in the decisional loop; the device gives control to patients on how to respond and decide on a therapeutic course ahead of time. Being kept in the decisional loop can positively increase patients’ quality of life; however, doing so does not come free of ethical concerns. There is currently a lack of evidence concerning the various impacts of closed-loop system BCIs on patients’ decisionmaking processes, especially how being in the decisional loop impacts patients’ sense of autonomy. This article addresses these gaps by providing data that we obtained from a first-in-human clinical trial involving patients implanted with advisory brain devices. This article explores ethical issues related to the risks involved in being kept in the decisional loop.
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