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.
Patients aged 20 and above.
Localized refractory epilepsy (ineffective with maximum doses of two or more anti-seizure medications).
Seizure frequency records for at least one month prior to the trial.
Patients who have undergone a complete preoperative examination, including EEG, MRI, and positron emission tomography (PET).
This product is not suitable for individuals with contraindications related to MRI, such as those with metallic implants, those unable to undergo MRI, severe claustrophobia, or those with adverse reactions to contrast agents.
Individuals with implants in the brain or skull, such as shunts, electrodes, hard brain membrane patches, or electrode plates, that cannot be avoided along the expected path of brain ultrasound.
Patients along the expected path of brain ultrasound who cannot avoid structures or sensitive tissues with energy absorption (e.g., previous brain shunt surgery sites, surgical metal clips, or any hard implants).
Patients with extensive scabbing along the expected path of brain ultrasound.
Single group
Exablate 4000 Transcranial MRgfUS System
DeviceFocused ultrasound interrupt structure of epilepsy network to improve seizure.
pulse rate [Safety]
vital sign
blood oxygen saturation level [Safety]
vital sign
MRI [Safety]
Safety and Tolerability
Incidence of Treatment-Emergent Adverse Events [Tolerability]
To record the adverse events
seizure frequency [efficacy]
The treatment response is assessed based on the overall observation of seizure frequency.
scalp EEG [efficacy]
The treatment response is assessed based on the scalp EEG (electroencephalogram).
No. of seizure-free days [efficacy]
The treatment response is assessed based on the number of seizure-free days within the entire monitoring period.
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Taipei Veterans General Hospital, Taiwan
Lead sponsor
InSightec
Collaborator
