This will be a prospective, pilot, open-label, two-arm, parallel-group, randomized study to evaluate the efficacy and safety of low-intensity focused ultrasound (LIFU) neuromodulation using NaviFUS System in patients with drug-resistant epilepsy (DRE).
Male or female patients aged over than and equal to 18 years old.
Patients with drug-resistant epilepsy (defined as at least 3 ASM failed) and 1-4 ASM at the time of study entry.
Epileptogenic focus (or foci) is determined by comprehensive presurgical evaluation.
At least 4 focal-onset seizures with objectively visible or significantly disabling manifestations in the 8-week baseline and at least one seizure per month in the baseline.
Patients with concurrent active psychiatric or mood disorders that have been assessed to interfere with participation in the study.
Presence of pacemaker, implantable cardioverter-defibrillator (ICD), permanent medication pumps, cochlear implants, or deep brain stimulation (DBS).
The skull bone area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), wounds, or atrophy of the scalp.
Image documented calcified lesion in the FUS exposure path.
Parallel
Focused ultrasound (FUS) treatment
DeviceThe mechanism of action of FUS neuromodulation involves the activation of voltage-gated ion channels to induce temporary neuromodulation.
Changes of seizure frequency after treatment compared to baseline
The changes in patient's seizure frequency from baseline through the study completion will be assessed based on the seizure diaries.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The incidence and severity of AEs associated with LIFU neuromodulation in patients with DRE.
Responder rate (≧50% seizure reduction)
The changes in responder rate (≧50% seizure reduction) from baseline through the study completion will be assessed based on the seizure diaries.
Change from baseline in number of seizure-free days
The changes in number of seizure-free days from baseline through the study completion will be assessed based on the seizure diaries.
Change from baseline in subjective seizure strength
The changes in subjective seizure strength from baseline through the study completion will be assessed based on the seizure diaries.
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