Small Brains, Big Data: The Current Landscape of Pediatric Brain-Computer Interface Clinical Trials.

Abstract

IntroductionBrain-computer interfaces (BCIs) have shown meaningful functional benefits for patients with severe neurologic and neuromuscular disabilities. Pediatric populations with similar conditions may likewise benefit, yet the scope and characteristics of pediatric BCI (pBCI) research remain unclear. We systematically characterize the global clinical trial landscape of pBCI studies to inform clinical and regulatory strategies.MethodsWe conducted a registry-based cross-sectional descriptive analysis of recruiting, ongoing, and planned pBCI clinical trials. ClinicalTrials.gov and 3 international registries were searched using "brain-computer interface," "BCI," "brain-machine interface," "neural interface," "neuroprosthetics," and "EEG-based assistive technology" and limited to participants aged 0-17 years. Two independent reviewers screened records and extracted key study variables, including device type (implanted vs non-implanted), enrollment, duration, phase, and condition studied; discrepancies were resolved by consensus.ResultsEleven studies met the inclusion criteria. Trials encompassed 7 countries. Eight studies evaluated non-implanted devices and 3 for implanted systems. Duration and enrollment differed descriptively between groups. Non-implanted trials had a median duration of 56.0 days (IQR: 42.0-182.6), whereas implanted trials had a median duration of 365.3 days (IQR: 91.3-1826.4 days). Non-implanted trials had a median enrollment of 29 participants (IQR: 19-51.5; range: 8-400), whereas implanted trials had a median enrollment of 8 participants (IQR: 3-30; range: 3-30). Only 4 studies exclusively enrolled pediatric participants; the others recruited both pediatric and adult participants.ConclusionsCurrent pBCI clinical research remains limited in scope, and children may be inadequately prioritized in BCI research.