Clinical Trial

Acute Stimulation and Modulation of Stereotyped High-Frequency Oscillations

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Summary
Overall, this study will investigate the functional utility of stereotyped HFOs by capturing them with a new implantable system (Brain Interchange - BIC of CorTec), which can sample neural data at higher rates \>=1kHz and deliver targeted electrical stimulation to achieve seizure control. In contrast to current closed-loop systems (RNS), which wait for the seizure to start before delivering stimulation, the BIC system will monitor the spatial topography and rate of stereotyped HFOs and deliver targeted stimulation to these HFO generating areas to prevent seizures from occurring. If the outcomes of our research in an acute setting become successful, the investigators will execute a clinical trial and run the developed methods with the implantable BIC system in a chronic ambulatory setting.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-03-20; most recent amendment 2026-05-15.
Trial Details
NCT Number NCT06898138
Lead Sponsor Mayo Clinic
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS), Baylor College of Medicine, CorTec GmbH
Conditions Epilepsy
Enrollment 8 participants
Start Date 2026-11-01
Primary Completion 2029-02-15 (estimated)
Study Completion 2029-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-11