Jul 2026· Journal of Child Neurology· pp.
8830738261467621
· 0 citations· 22 references
Medicine
TL;DR
The global clinical trial landscape of pBCI studies is systematically characterized to inform clinical and regulatory strategies and to suggest children may be inadequately prioritized in BCI research.
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.
BACKGROUND
Implanted brain-computer interfaces (iBCIs) can record signals directly from the brain and translate them into computer commands continuously, at high speed and fidelity. Over 150 people worldwide have been implanted with an iBCI, and this number is expected to increase rapidly as iBCIs become commercially available. Despite the progress that is being made in the development of safe, wireless, and highly effective iBCIs, none of these have been implemented in youth or adults with pediatric-onset conditions.
OBJECTIVE
Pediatric-onset conditions, such as Cerebral Palsy (CP), represent a large proportion of the global burden of complex and severe disability. Since affected individuals, particularly youth, will likely benefit significantly from iBCIs, they should not be left behind in technological progress that would be life-changing. We outlined the evidence gaps, steps required, and arguments for greater focus on this population in iBCI research and development.
METHODS
Here, we present the result of two years of cumulative effort, combining expert opinions and findings from multiple transdisciplinary engagement sessions, including the first International Virtual Summit on Implanted BCIs for Children with Complex Needs, follow-up themed workgroup sessions, and a final in-person workshop held at the 11th International BCI Society Meeting.
RESULTS
We established a world-first visionary, community-and-partner-engaged roadmap for the design, development, and implementation of iBCIs for youth with CP to meaningfully interact with the world.
CONCLUSIONS
Developing iBCI systems for youth with CP requires a fundamental shift toward child‑centric neuroscience, engineering, and user‑driven design rather than adapting adult‑oriented technologies.
M. Branco, E. Kinney-Lang, N. Ruest et al.· Neurorehabilitation and Neur...· 0 citations
The available evidence suggests that continued multidisciplinary collaboration and technological innovation will facilitate the progressive integration of BCIs into routine neurosurgical care, supporting personalized therapeutic strategies aimed at improving functional recovery, communication, and quality of life in patients with complex neurological disorders.
Alejandra Mendoza Ortiz, Marco Antônio, Ortiz Ayala et al.· International science journa...· 0 citations
The study stresses the necessity of embedding relational autonomy and neural rights into BCI development, tying technological trajectories to governance demands in order to shape responsible paths for future neurotechnologies.
Yuzhang Wu· Theoretical and Natural Scie...· 0 citations
Objectives. This narrative review examines first-generation brain-computer interfaces (BCIs) across three domains: clinical translation in amyotrophic lateral sclerosis (ALS), locked-in syn-drome (LIS), tetraplegia, spinal cord injury (SCI), pharmacoresistant epilepsy and movement dis-orders; comparative safety covering neurological, infectious, technical and cybersecurity risks; and the emerging neuro-rights regulatory debate.
Methods. Literature was retrieved from PubMed/MEDLINE, Scopus, Web of Science, IEEE Xplore and legal-academic databases, covering peer-reviewed clinical trials, systematic reviews, safety datasets, technical analyses and bioethics scholarship through 2026.
Key Findings. The BrainGate dataset (14 adults, 12,203 implant-days) reported 68 device-related adverse events and six serious adverse events, with no intracranial infections, explantations or at-tributable deaths. The endovascular SWITCH trial found zero serious adverse events at 12 months. Safety risk follows access route and implant chronicity rather than a simple invasive/non-invasive binary. Closed-loop neurostimulation reduces seizure frequency by 60-65% in pharmacoresistant epilepsy; adaptive deep brain stimulation is the most mature movement-disorder application. The neuro-rights literature converges on mental privacy, integrity, autonomy and cognitive liberty as core protected interests.
Conclusions. Responsible BCI deployment requires matching the least invasive platform to the indication, consent specific to device capabilities, cybersecurity treated as patient safety, and pro-spective neural-data governance built into device design.
Przemysław Piterak, Damian Danilczuk, J. Buszko et al.· International Journal of Inn...· 0 citations
For children with severe physical and cognitive disabilities (e.g. iatrogenic neurologic injury, congenital myelopathy, or quadriplegic cerebral palsy), there are limited therapeutic options. Scientific and clinical developments in implantable brain-computer interface (BCI) technology are in clinical trials in adults. The ethical issues around implantable BCI research in adults have recently been examined, but to date, only limited literature is available on the ethical issues that are attendant with implantable pediatric BCI research. Here, we summarize the ethical issues, focusing on (1) whether invasive BCI research should proceed in children, (2) regulatory considerations, (3) study design considerations, (4) pediatric recipient selection for invasive BCI trials, (5) special problems regarding informed consent in this context, and (6) related psychosocial and public perception considerations. We conclude with specific recommendations regarding ethically informed design of invasive pediatric BCI trials.
C. Bobier, D. Hurst· AJOB Neuroscience· 1 citation
Non-invasive EEG-based Brain–Computer Interface (BCI), when used alongside conventional physiotherapy and other rehabilitation approaches such as functional electrical stimulation, robotic-assisted therapy, and virtual reality, was associated with improved upper-limb motor function, motor control, functional independence, and neuroplasticity in individuals with stroke.
kumar S Anil, B. Sharvani, M. H· World Journal of Advanced Re...· 0 citations
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