Health Technology/clinical-trials

Phase I Feasibility Trial Opens: Novel Closed-Loop Brain Stimulation System Targets Pre-Seizure Activity in Drug-Resistant Epilepsy

247 Health News Editorial

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26 May 2026

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4 min read

·clinical-trials

Mayo 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

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  2. 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. 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. 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. 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
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  7. 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. 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. 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. 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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