A Pilot Study to Evaluate the Efficacy and Safety of NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy

Prior treatment

• 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).
• Patients have received an investigational drug or an investigational device within 4 weeks prior to the study
• Vagus nerve stimulation (VNS) dosing changes within 2 months before baseline (screening period).
• Radiofrequency thermocoagulation (RFTC) within 2 months before baseline (screening period).

Other illness

• The skull bone area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), wounds, or atrophy of the scalp.
• Known sensitivity/allergy to Magnetic Resonance Imaging (MRI) contrast agents or any of its components; having metallic implants that are assessed as unsuitable for MRI examination.
• Use of any recreational drugs or history of drug addiction or known history of substance or alcohol abuse.
• Any other condition that, in the investigator's judgment, might affect study endpoints or might increase the risk to the patients or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
• Any other condition that, in the investigator's judgment, patient not applicable to participate this study.

Lab values

• Abnormal coagulation profile:
  • Platelet (PLT) \< 100,000/μL.
  • prothrombin time (PT) \> 15 sec.
  • activated partial thromboplastin time (APTT) \> 45 sec.
  • international normalized ratio (INR) \> 1.5.
  • Patients requiring anticoagulant medications.

Other

• Image documented calcified lesion in the FUS exposure path.
• Pregnant or breast-feeding women.
• Coexisting medical problems of sufficient severity to limit compliance with the study.
• Any ASM treatment change during the baseline (screening period).
• Patient has an IQ \< 70, based on the Wechsler Abbreviated Scale of Intelligence (WASI-III or IV).

• 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.
• Willing and able to sign written informed consent and be able to comply with the study protocol during the study period.