NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy

Exclusion Criteria

• •1. Patients with concurrent active psychiatric or mood disorders that in the opinion of the investigator would interfere with participation in the study.
• •2. Presence of pacemaker, implantable cardioverter-defibrillator (ICD), permanent medication pumps, cochlear implants, or deep brain stimulation (DBS)
• •3. The skull bone area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp.
• •4. Clips or other metallic implanted objects in the FUS exposure path, except shunts.
• •5. Abnormal coagulation profile:
• •1. Platelet (PLT) \< 100,000/μL.
• •2. prothrombin time (PT) \>14 sec.
• •3. activated partial thromboplastin time (APTT) \>36 sec.
• •4. and international normalized ratio (INR) \> 1.3.
• •6. Pregnant or breast-feeding women.
• •7. Coexisting medical problems of sufficient severity to limit compliance with the study.
• •8. Known sensitivity/allergy to Magnetic Resonance Imaging (MRI) contrast agents or any of its components.
• •9. Use of any recreational drugs or history of drug addiction or known history of substance or alcohol abuse.
• •10. Patients have received an investigational drug or an investigational device within 4 weeks prior to the study.
• •11. 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.
• •12. Any ASM treatment change during the baseline (screening period)
• •13. Vagus nerve stimulation (VNS) dosing changes within 2 months before baseline (screening period).
• •14. Radiofrequency thermocoagulation (RFTC) within 2 months before baseline (screening period).
• •15. Any other condition that, in the investigator's judgment, patient not applicable to participate this study.