Analysis of Global Clinical Trial Registration Status for Brain-Computer Interface

LU Yan; PAN Lizi; YAN Shu; CHEN Juan; OUYANG Zhaolian

doi:10.3969/j.issn.1674-1633.20241660

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China Medical Devices ›› 2025, Vol. 40 ›› Issue (3) : 16-21. DOI: 10.3969/j.issn.1674-1633.20241660

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Analysis of Global Clinical Trial Registration Status for Brain-Computer Interface

LU Yan, PAN Lizi, YAN Shu, CHEN Juan, OUYANG Zhaolian

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Abstract

ObjectiveTo analyze the global registration status of brain-computer interface (BCI) clinical trials and provide data to support further clinical research of this technology. Methods Based on the registration data of BCI related clinical trials in ClinicalTrials.gov, bibliometrics approach was applied to analyze the number and annual trend of registration, national distribution and international cooperation, sponsor type and country distribution, study type and recruitment, classification of indications and their characteristics. Results As of October 2024, a total of 194 BCI related clinical trials were registered worldwide, and the number of registrations was generally on the rise. Among all the countries that carried out clinical trials, the United States ranked first with 80 trials, while no other countries surpassed 20, and there were only 3 trials involved international collaboration. Sponsors were predominantly universities and research institutions (48.7%), with the United States having the largest number of sponsors. Of all the clinical trials, 88.1% were intervention studies, 38.1% were completed, 26.3% recruited fewer than 10 patients, and almost all of the trial subjects were recruited without gender restriction and included adults. BCI related clinical trials focused on rehabilitation and treatment of neurological diseases, the main indications included stroke, spinal cord injury, amyotrophic lateral sclerosis, and quadriplegia. Conclusion The global clinical research activity in BCI technology is steadily increasing, demonstrating significant application potential.

Key words

brain-computer interface (BCI); human-computer interaction; wearable devices; machine learning; ClinicalTrials.gov; bibliometric analysis

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LU Yan, PAN Lizi, YAN Shu, et al. Analysis of Global Clinical Trial Registration Status for Brain-Computer Interface[J]. China Medical Devices, 2025, 40(3): 16-21 https://doi.org/10.3969/j.issn.1674-1633.20241660

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