Phase I Feasibility Trial Opens: Novel Closed-Loop Brain Stimulation System Targets Pre-Seizure Activity in Drug-Resistant Epilepsy
247 Health News Editorial
·26 May 2026
·4 min read
·clinical-trialsMayo Clinic launches first-in-human trial of novel Brain Interchange System that targets pre-seizure brain activity to prevent epileptic seizures, rather than waiting to abort them after onset. The study evaluates closed-loop stimulation guided by high-frequency oscillations in 8 patients with drug-resistant epilepsy.
Originally reported by ClinicalTrials.gov
References
- 1.Epilepsy Australia. (2023). Epilepsy facts and statistics. https://www.epilepsyaustralia.net/about-epilepsy/epilepsy-facts-and-statistics/
- 2.Frauscher, B., Bartolomei, F., Kobayashi, K., Cimbalnik, J., van 't Klooster, M. A., Rampp, S., Otsubo, H., Höller, Y., Wu, J. Y., Asano, E., Engel Jr, J., Kahane, P., Jacobs, J., & Gotman, J. (2017). High-frequency oscillations: The state of clinical research. Epilepsia, 58(8), 1316-1329. https://doi.org/10.1111/epi.13829
- 3.Heck, C. N., King‐Stephens, D., Massey, A. D., Nair, D. R., Jobst, B. C., Barkley, G. L., Salanova, V., Cole, A. J., Smith, M. C., Gwinn, R. P., Skidmore, C., Van Ness, P. C., Bergey, G. K., Park, Y. D., Miller, I., Geller, E., Rutecki, P. A., Zimmerman, R., Spencer, D. C., ... NeuroPace RNS System Pivotal Study Investigators. (2014). Two‐year seizure reduction in adults with medically intractable partial onset epilepsy treated with responsive neurostimulation: final results of the RNS System Pivotal trial. Epilepsia, 55(3), 432-441. https://doi.org/10.1111/epi.12534
- 4.Höller, Y., Kutil, R., Klaffenböck, L., Thomschewski, A., Höller, P. M., Bathke, A. C., Jacobs, J., Fell, J., Dickten, H., Gerner, A., Leitinger, M., Kalss, G., Kreidenhuber, R., Kuchukhidze, G., Dobesberger, J., & Trinka, E. (2015). High‐frequency oscillations in epilepsy and surgical outcome. A meta‐analysis. Frontiers in Human Neuroscience, 9, 574. https://doi.org/10.3389/fnhum.2015.00574
- 5.Jacobs, J., Staba, R., Asano, E., Otsubo, H., Wu, J. Y., Zijlmans, M., Mohamed, I., Kahane, P., Dubeau, F., Navarro, V., & Gotman, J. (2012). High-frequency oscillations (HFOs) in clinical epilepsy. Progress in Neurobiology, 98(3), 302-315. https://doi.org/10.1016/j.pneurobio.2012.03.001
- 6.Kwan, P., Arzimanoglou, A., Berg, A. T., Brodie, M. J., Allen Hauser, W., Mathern, G., Moshé, S. L., Perucca, E., Wiebe, S., & French, J. (2010). Definition of drug resistant epilepsy: consensus proposal by the ad hoc Task Force of the ILAE Commission on Therapeutic Strategies. Epilepsia, 51(6), 1069-1077. https://doi.org/10.1111/j.1528-1167.2009.02397.x
- 7.Mayo Clinic. (2024). Acute stimulation for the modulation of epileptic events with a closed-loop brain interchange system in drug resistant epilepsy. ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT06898138
- 8.Ryvlin, P., Cross, J. H., & Rheims, S. (2014). Epilepsy surgery in children and adults. The Lancet Neurology, 13(11), 1114-1126. https://doi.org/10.1016/S1474-4422(14)70156-5
- 9.Whitehead, A. L., Julious, S. A., Cooper, C. L., & Campbell, M. J. (2016). Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Statistical Methods in Medical Research, 25(3), 1057-1073. https://doi.org/10.1177/0962280215588241
- 10.Zijlmans, M., Jiruska, P., Zelmann, R., Leijten, F. S., Jefferys, J. G., & Gotman, J. (2012). High‐frequency oscillations as a new biomarker in epilepsy. Annals of Neurology, 71(2), 169-178. https://doi.org/10.1002/ana.22548
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247 Health News Editorial
247 Health News is a medical intelligence platform delivering evidence-based research appraisals, clinical trial monitoring, and health technology news for healthcare professionals.
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