Clinical Trial

Focused Ultrasound for Drug-resistant Epilepsy

Recruiting
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Summary
Focused ultrasound (FUS) has been shown to differentially lesion or modulate (excite and inhibit) brain circuit and neural activity across a broad range of acoustic stimulus parameters (intensity, duty cycle, pulse repetition frequency and pulse duration) for decades. From our previous study, FUS sonication may suppress the number of epileptic signal bursts observed in EEG recordings after the induction of acute epilepsy. The presence of the suppressive effect was found in terms of the number of epileptic EEG spikes from the analysis of the unfiltered and theta-band EEG activity, and further discontinue the seizure attacks. EEG activity has also been consistently reported to have a positive correlation with the level of epilepsy, and FUS-mediated reduction of epileptic EEG activity was most notably observed, no matter lesioning or modulating effects. The aims of this study are to demonstrate the safety and efficacy of FUS technology in epilepsy patients and to estimate the optimal parameters of focused ultrasound exposure that will be used in the case of epilepsy.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-03-04.
Trial Details
NCT Number NCT06292494
Lead Sponsor Taipei Veterans General Hospital, Taiwan
Collaborators: InSightec
Conditions Focused Ultrasound, MR-guided FUS, Drug Refractory Epilepsy, Drug Resistant Epilepsy, Medication Resistant Epilepsy
Enrollment 20 participants
Start Date 2024-01-01
Primary Completion 2027-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-09-09