Clinical Validation of BCI-Controlled Wheelchairs in Subjects With Severe Spinal Cord Injury.

Brain-controlled wheelchairs are one of the most promising applications that can help people gain mobility after their normal interaction pathways have been compromised by neuromuscular diseases. The feasibility of using brain signals to control wheelchairs has been well demonstrated by healthy people in previous studies. However, most potential users of brain-controlled wheelchairs are people suffering from severe physical disabilities or who are in a "locked-in" state. To further validate the clinical practicability of our previously proposed P300-based brain-controlled wheelchair, in this study, 10 subjects with severe spinal cord injuries participated in three experiments and completed ten predefined tasks in each experiment. The average accuracy and information transfer rate (ITR) were 94.8% and 4.2 bits/min, respectively. Moreover, we evaluated the physiological and cognitive burdens experienced by these individuals before and after the experiments. There were no significant changes in vital signs during the experiment, indicating minimal physiological and cognitive burden. The patients' average systolic blood pressure before and after the experiment was 113±13.7 mmHg and 114±11.9 mmHg, respectively (P = 0.122). The patients' average heart rates before and after the experiment were 79±8.4/min and 79±8.2/min, respectively (P = 0.147). The average task load, measured by the National Aeronautics and Space Administration task load index, ranged from 10.0 to 25.5. The results suggest that the proposed P300-based brain-controlled wheelchair is safe and reliable; additionally, it does not significantly increase the patient's physical and mental task burden, demonstrating its potential value in clinical applications. Our study promotes the development of a more practical brain-controlled wheelchair system.