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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Focused ultrasound interrupt structure of epilepsy network to improve seizure.
Taipei Veterans General Hospital
Taipei, Taiwan
RECRUITINGpulse rate [Safety]
vital sign
Time frame: pre- and post- treatment immediately
blood oxygen saturation level [Safety]
vital sign
Time frame: pre- and post- treatment immediately
MRI [Safety]
Safety and Tolerability
Time frame: pre- and post- treatment immediately
Incidence of Treatment-Emergent Adverse Events [Tolerability]
To record the adverse events
Time frame: during and post- treatment immediately
seizure frequency [efficacy]
The treatment response is assessed based on the overall observation of seizure frequency.
Time frame: pre- and post- treatment immediately and 1,3,6,12 month
scalp EEG [efficacy]
The treatment response is assessed based on the scalp EEG (electroencephalogram).
Time frame: pre- and post- treatment immediately and 1,3,6,12 month
No. of seizure-free days [efficacy]
The treatment response is assessed based on the number of seizure-free days within the entire monitoring period.
Time frame: pre- and post- treatment immediately and 1,3,6,12 month
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