Developing a Clinical Tool to Measure How Assistive Technologies and Brain-Computer Interfaces Help Digital Independence

What this Trial Is About

Researchers are evaluating a new way to measure how assistive technologies ATs and brain-computer interfaces BCIs help people with severe motor impairments operate digital devices like computers and phones. This study aims to create a standardized Digital Assessment Interface DAI that simulates important online and digital tasks. The goal is to develop an index that combines performance, clinician-reported, and patient-reported outcomes to compare and quantify the real-world benefits of different ATs and BCIs across various user groups, including those with spinal cord injury SCI, amyotrophic lateral sclerosis ALS, and healthy individuals. Participants will use several assistive devices, including eye trackers, mouth-operated joysticks, non-invasive EEG headsets, implantable BCIs, voice control systems, and their personal assistive technologies. Training sessions involve practicing digital tasks such as clicking, typing, scrolling, and drawing through a customized Digital Training Interface. The study includes multiple sessions both in-clinic and at home, with rest periods to ensure comfort and skill retention. Participants experience the devices in a randomized order to assess their functional performance comprehensively. During the study, participants will complete various assessments including performance outcomes on the DAI, questionnaires on task load and system usability from both participant and clinician perspectives, and psychosocial impact surveys. Additional evaluations include neurological classifications, functional rating scales, cognitive assessments, and quality of life measures. These outcomes will be measured at every visit through study completion. The involvement typically lasts about three hours per session, with breaks as needed, and the study will continue until June 2027, aiming to ensure reliable and valid measurement of digital independence for users of assistive technologies and BCIs.

Clinical Outcome Assessment for AT & BCI