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

Area of Science:

• Neuroscience
• Biomedical Engineering
• Clinical Trials

Background:

• Brain-computer interfaces (BCIs) offer significant functional advantages for individuals with severe neurological and neuromuscular impairments.
• The potential benefits of BCIs for pediatric populations are recognized, but the current research landscape remains underexplored.
• Understanding the scope and characteristics of pediatric BCI (pBCI) research is crucial for informing clinical and regulatory advancements.

Purpose of the Study:

• To systematically characterize the global clinical trial landscape of pediatric brain-computer interface (pBCI) studies.
• To analyze key variables including device type, enrollment numbers, study duration, and target conditions in pBCI research.
• To inform future clinical and regulatory strategies for advancing pBCI technologies.

Main Methods:

• A cross-sectional descriptive analysis of recruiting, ongoing, and planned pBCI clinical trials was conducted.
• Searches were performed on ClinicalTrials.gov and three international registries using multiple BCI-related keywords.
• Studies were limited to participants aged 0-17 years, with data extracted by two independent reviewers.

Main Results:

• Eleven pBCI studies across seven countries met the inclusion criteria, with eight utilizing non-implanted devices and three using implanted systems.
• Non-implanted trials showed a median duration of 56 days and median enrollment of 29 participants, while implanted trials had a median duration of 365 days and median enrollment of 8 participants.
• Only four studies exclusively enrolled pediatric participants; the majority included both pediatric and adult cohorts.

Conclusions:

• Current pediatric brain-computer interface clinical research is limited in scope and scale.
• Pediatric populations appear to be inadequately prioritized in the current BCI research landscape.
• Further dedicated research is needed to fully realize the potential of pBCI for children with disabilities.