FIRST-GENERATION BRAIN–COMPUTER INTERFACES: A NARRATIVE REVIEW OF CLINICAL TRANSLATION, COMPARATIVE SAFETY, AND NEURO-RIGHTS

Authors

DOI:

https://doi.org/10.31435/ijitss.3(51).2026.5813

Keywords:

Brain-Computer Interface; BrainGate; Closed-Loop Stimulation; Clinical Translation; Neuro-Rights; Neu-Roethics

Abstract

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.

References

Alsaigh, R., Mehmood, R., Katib, I. A., Liang, X., Alshanqiti, A., Corchado, J., & See, S. (2024). Harmonizing AI governance regulations and neuroinformatics: Perspectives on privacy and data sharing. Frontiers in Neuroinformatics, 18, 1472653. https://doi.org/10.3389/fninf.2024.1472653

Arlotti, M., Colombo, M., Bonfanti, A., Mandat, T., Lanotte, M., Pirola, E., Borellini, L., Rampini, P., Eleopra, R., Rinaldo, S., Romito, L., Janssen, M., Priori, A., & Marceglia, S. (2021). A new implantable closed-loop clinical neural interface: First application in Parkinson’s disease. Frontiers in Neuroscience, 15, 763235. https://doi.org/10.3389/fnins.2021.763235

Bacher, D., Jarosiewicz, B., Masse, N. Y., Stavisky, S., Simeral, J., Newell, K., Oakley, E. M., Cash, S., Friehs, G., & Hochberg, L. (2015). Neural point-and-click communication by a person with incomplete locked-in syndrome. Neurorehabilitation and Neural Repair, 29(5), 462–471. https://doi.org/10.1177/1545968314554624

Barrera, M. E. G., & Covarrubias, J. Z. L. (2025). Beyond data privacy: The case for mental privacy and neuro-rights. European Journal of Privacy Law & Technologies. https://doi.org/10.57230/ejplt25sibmegbjzlc

Barrese, J. C., Rao, N. G., Paroo, K., Triebwasser, C., Vargas-Irwin, C., Franquemont, L., & Donoghue, J. (2013). Failure mode analysis of silicon-based intracortical microelectrode arrays in non-human primates. Journal of Neural Engineering, 10(6), 066014. https://doi.org/10.1088/1741-2560/10/6/066014

Burwell, S., Sample, M., & Racine, E. (2017). Ethical aspects of brain computer interfaces: A scoping review. BMC Medical Ethics, 18(1), 60. https://doi.org/10.1186/s12910-017-0220-y

Casagran, C. B. (2025). Neurotechnology and human rights in Europe: Towards a legal-neuroethical framework (CA-EN). Revista Catalana de Dret Públic, (71). https://doi.org/10.58992/rcdp.i71.2025.4468

Chatelle, C., Spencer, C. A., Cash, S., Hochberg, L., & Edlow, B. (2018). Feasibility of an EEG-based brain-computer interface in the intensive care unit. Clinical Neurophysiology, 129(8), 1519–1525. https://doi.org/10.1016/j.clinph.2018.04.747

Cornejo, Y. (2024). Neurorights, neurotechnologies and personal data: Review of the challenges of mental autonomy. Journal of Digital Technologies and Law, 2(4), 814–845. https://doi.org/10.21202/jdtl.2024.36

Cornejo-Plaza, M. I., Cippitani, R., & Pasquino, V. (2024). Chilean Supreme Court ruling on the protection of brain activity: Neurorights, personal data protection, and neurodata. Frontiers in Psychology, 15, 1330439. https://doi.org/10.3389/fpsyg.2024.1330439

Denning, T., Matsuoka, Y., & Kohno, T. (2009). Neurosecurity: Security and privacy for neural devices. Neurosurgical Focus, 27(1), E7. https://doi.org/10.3171/2009.4.FOCUS0985

Goering, S., Klein, E., Sullivan, L. S., Wexler, A., Arcas, B. A. y., Bi, G., Carmena, J., Fins, J., Friesen, P., Gallant, J., Huggins, J., Kellmeyer, P., Marblestone, A. H., Mitchell, C., Parens, E., Pham, M., Rubel, A., Sadato, N., Teicher, M., & Yuste, R. (2021). Recommendations for responsible development and application of neurotechnologies. Neuroethics, 14(3), 365–386. https://doi.org/10.1007/s12152-021-09468-6

Grosse-Wentrup, M. (2019). The elusive goal of BCI-based communication with CLIS-ALS patients. In 2019 7th International Winter Conference on Brain-Computer Interface (BCI) (pp. 1–3). IEEE. https://doi.org/10.1109/IWW-BCI.2019.8737310

Guy, V., Soriani, M., Bruno, M., Papadopoulo, T., Desnuelle, C., & Clerc, M. (2018). Brain computer interface with the P300 speller: Usability for disabled people with amyotrophic lateral sclerosis. Annals of Physical and Rehabilitation Medicine, 61(1), 5–11. https://doi.org/10.1016/j.rehab.2017.09.004

Holt, M. W., Robinson, E. C., Shlobin, N., Hanson, J. T., & Bozkurt, I. (2023). Intracortical brain-computer interfaces for improved motor function: A systematic review. Reviews in the Neurosciences, 35(2), 213–223. https://doi.org/10.1515/revneuro-2023-0077

Hu, X., Li, N., Pang, M., Bai, S., Mo, J., Yao, S., Lu, Y., Huang, M., Di, J., Kang, Y., Tang, J., Zhang, H., Zhao, T., He, J., He, L., Xie, R., Liu, B., Xu, G., Hu, X., & Rong, L. (2026). Brain-computer interface-controlled exoskeleton training for lower-limb rehabilitation in spinal cord injury: A pilot randomized clinical trial. Annals of Neurology. Advance online publication. https://doi.org/10.1002/ana.78144

Jiang, X., Fan, J., Zhu, Z., Wang, Z., Guo, Y., Liu, X., Jia, F., & Dai, C. (2023). Cybersecurity in neural interfaces: Survey and future trends. Computers in Biology and Medicine, 167, 107604. https://doi.org/10.1016/j.compbiomed.2023.107604

Kellmeyer, P. (2022). ‘Neurorights’: A human rights-based approach for governing neurotechnologies. In S. Voeneky, P. Kellmeyer, O. Mueller, & W. Burgard (Eds.), The Cambridge handbook of responsible artificial intelligence (pp. 412–426). Cambridge University Press. https://doi.org/10.1017/9781009207898.032

Klein, E., & Rubel, A. (2023). Ethics of brain–computer interfaces. In C. S. Nam, A. Nijholt, & F. Lotte (Eds.), Brain–computer interfaces handbook: Technological and theoretical advances. CRC Press.

Kuo, C., White-Dzuro, G., & Ko, A. (2018). Approaches to closed-loop deep brain stimulation for movement disorders. Neurosurgical Focus, 45(2), E2. https://doi.org/10.3171/2018.5.FOCUS18173

Lega, B., Serruya, M., & Zaghloul, K. (2011). Brain-machine interfaces: Electrophysiological challenges and limitations. Critical Reviews in Biomedical Engineering, 39(1), 5–28. https://doi.org/10.1615/CRITREVBIOMEDENG.V39.I1.20

Liang, S., Shaw, F., Young, C., Chang, D., & Liao, Y. (2010). A closed-loop brain computer interface for real-time seizure detection and control. In 2010 Annual International Conference of the IEEE Engineering in Medicine and Biology (pp. 4950–4953). IEEE. https://doi.org/10.1109/IEMBS.2010.5627243

Lu, C. W., Patil, P. G., & Chestek, C. (2012). Current challenges to the clinical translation of brain machine interface technology. International Review of Neurobiology, 107, 137–160.

Mitchell, P., Lee, S. C. M., Yoo, P., Morokoff, A. P., Sharma, R. P., Williams, D., MacIsaac, C., Howard, M., Irving, L., Vrljic, I., Williams, C., Bush, S., Balabanski, A., Drummond, K., Desmond, P., Weber, D., Denison, T., Mathers, S., O'Brien, T. J., … Campbell, B. (2023). Assessment of safety of a fully implanted endovascular brain-computer interface for severe paralysis in 4 patients: The Stentrode with thought-controlled digital switch (SWITCH) study. JAMA Neurology, 80(3), 270–278. https://doi.org/10.1001/jamaneurol.2022.4847

Pandarinath, C., Nuyujukian, P., Blabe, C., Sorice, B. L., Saab, J., Willett, F. R., Hochberg, L., Shenoy, K., & Henderson, J. (2017). High performance communication by people with paralysis using an intracortical brain-computer interface. eLife, 6, e18554. https://doi.org/10.7554/eLife.18554

Parra, V. M. (2025). BCI, personal identity and autonomy: Ulysses on the Ship of Theseus. The Age of Human Rights Journal, (25), 1–23. https://doi.org/10.17561/tahrj.v25.9773

Rubin, D., Ajiboye, A., Barefoot, L., Bowker, M., Cash, S., Chen, D., Donoghue, J., Eskandar, E., Friehs, G., Grant, C., Henderson, J., Kirsch, R., Marujo, R. M., Masood, M., Mernoff, S., Miller, J. P., Mukand, J. A., Penn, R., Shefner, J., … Hochberg, L. (2023). Interim safety profile from the feasibility study of the BrainGate neural interface system. Neurology, 100(11), e1177–e1192. https://doi.org/10.1212/WNL.0000000000201707

Rubin, D. B., & Hochberg, L. (2023). BrainGate: An intracortical brain-computer interface for the restoration of communication and functional independence for people with paralysis. In 2023 11th International Winter Conference on Brain-Computer Interface (BCI) (pp. 1–2). IEEE. https://doi.org/10.1109/BCI57258.2023.10078547

Salisbury, D., Parsons, T., Monden, K., Trost, Z., & Driver, S. (2016). Brain-computer interface for individuals after spinal cord injury. Rehabilitation Psychology, 61(4), 435–441. https://doi.org/10.1037/rep0000099

Serruya, M. (2014). Bottlenecks to clinical translation of direct brain-computer interfaces. Frontiers in Systems Neuroscience, 8, 226. https://doi.org/10.3389/fnsys.2014.00226

Shen, K., Chen, O., Edmunds, J. L., Piech, D. K., & Maharbiz, M. (2023). Translational opportunities and challenges of invasive electrodes for neural interfaces. Nature Biomedical Engineering, 7(4), 424–442. https://doi.org/10.1038/s41551-023-01021-5

Silvoni, S., Volpato, C., Cavinato, M., Marchetti, M., Priftis, K., Merico, A., Tonin, P., Koutsikos, K., Beverina, F., & Piccione, F. (2009). P300-based brain–computer interface communication: Evaluation and follow-up in amyotrophic lateral sclerosis. Frontiers in Neuroscience, 3, 60. https://doi.org/10.3389/neuro.20.001.2009

Silvoni, S., Cavinato, M., Volpato, C., Ruf, C. A., Birbaumer, N., & Piccione, F. (2013). Amyotrophic lateral sclerosis progression and stability of brain-computer interface communication. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration, 14(5–6), 390–396. https://doi.org/10.3109/21678421.2013.770029

Sisterson, N. D., Wozny, T. A., Kokkinos, V., Constantino, A., & Richardson, R. (2018). Closed-loop brain stimulation for drug-resistant epilepsy: Towards an evidence-based approach to personalized medicine. Neurotherapeutics, 16(1), 119–127. https://doi.org/10.1007/s13311-018-00682-4

Sun, Z., Hu, S., Zhu, J., Ye, Z., Ma, M., & Ma, G. (2025). The impact of non-invasive brain-computer interface technology on the therapeutic effect of patients with spinal cord injury: A summary of evidence based on meta-analysis. Journal of NeuroEngineering and Rehabilitation, 22, 22. https://doi.org/10.1186/s12984-025-01766-x

Vansteensel, M., Pels, E. G. M., Bleichner, M., Branco, M., Denison, T., Freudenburg, Z., Gosselaar, P., Leinders, S., Ottens, T., Boom, M. A. v. d., Rijen, P. V. v., Aarnoutse, E., & Ramsey, N. (2016). Fully implanted brain-computer interface in a locked-in patient with ALS. New England Journal of Medicine, 375(21), 2060–2066. https://doi.org/10.1056/NEJMoa1608085

Vassileva, A., Blooijs, D. V., Leijten, F., & Huiskamp, G. (2018). Neocortical electrical stimulation for epilepsy: Closed-loop versus open-loop. Epilepsy Research, 141, 95–101. https://doi.org/10.1016/j.eplepsyres.2018.02.010

Wang, W., Collinger, J., Degenhart, A. D., Tyler-Kabara, E., Schwartz, A., Moran, D., Weber, D., Wodlinger, B., Vinjamuri, R., Ashmore, R., Kelly, J. W., & Boninger, M. (2013). An electrocorticographic brain interface in an individual with tetraplegia. PLoS ONE, 8(2), e55344. https://doi.org/10.1371/journal.pone.0055344

Wolpaw, J., Bedlack, R., Reda, D., Ringer, R., Banks, P. G., Vaughan, T., Heckman, S. M., McCane, L., Carmack, C. S., Winden, S., McFarland, D., Sellers, E., Shi, H., Paine, T., Higgins, D., Lo, A., Patwa, H., Hill, K. J., Huang, G. D., & Ruff, R. (2018). Independent home use of a brain-computer interface by people with amyotrophic lateral sclerosis. Neurology, 91(3), e258–e267. https://doi.org/10.1212/WNL.0000000000005812

Wolpaw, J., Millán, J., & Ramsey, N. (2020). Brain-computer interfaces: Definitions and principles. Handbook of Clinical Neurology, 168, 15–23. https://doi.org/10.1016/B978-0-444-63934-9.00002-0

Zelmann, R., Paulk, A., Basu, I., Basu, I., Sarma, A. A., Yousefi, A., Yousefi, A., Crocker, B., Crocker, B., Eskandar, E., Eskandar, E., Williams, Z. M., Cosgrove, G., Weisholtz, D., Dougherty, D., Truccolo, W., Widge, A., Widge, A., & Cash, S. (2020). CLoSES: A platform for closed-loop intracranial stimulation in humans. NeuroImage, 223, 117314. https://doi.org/10.1016/j.neuroimage.2020.117314

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Published

2026-08-26

How to Cite

Piterak, P., Danilczuk , D. ., Buszko, J., Dyś, M. ., Baran, N. ., Bajkowska-Piterak, M., Szlachta-Gubernat, M., Adamiec, W., & Buż, A. (2026). FIRST-GENERATION BRAIN–COMPUTER INTERFACES: A NARRATIVE REVIEW OF CLINICAL TRANSLATION, COMPARATIVE SAFETY, AND NEURO-RIGHTS. International Journal of Innovative Technologies in Social Science, 2(3(51). https://doi.org/10.31435/ijitss.3(51).2026.5813

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