Brain-computer interfaces (BCIs) enabling the control of a personal computer could provide myriad benefits to individuals with disabilities including paralysis. However, to realize this potential, these BCIs must gain regulatory approval and be made clinically available beyond research participation. Therefore, a transition from engineering-oriented to clinically oriented outcome measures will be required in the evaluation of BCIs. This review examined how to assess the clinical benefit of BCIs for the control of a personal computer. We report that: (a) a variety of different patient-reported outcome measures can be used to evaluate improvements in how a patient feels, and we offer some considerations that should guide instrument selection. (b) Activities of daily living can be assessed to demonstrate improvements in how a patient functions, however, new instruments that are sensitive to increases in functional independence via the ability to perform digital tasks may be needed. (c) Benefits to how a patient survives has not previously been evaluated but establishing patient-initiated communication channels using BCIs might facilitate quantifiable improvements in health outcomes.
- activities of daily living
- brain-machine interface
- clinical trial
- health-related quality of life
- patient-reported outcomes