NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy

Inclusion Criteria:

1. Male or female patients aged ≥20 years old.

2. Patients with drug-resistant epilepsy (defined as at least 3 ASM failed) and 1-4 ASMat the time of study entry.

3. An epileptogenic foci is determined by comprehensive presurgical evaluation

4. Seizure number is countable and had been recorded at least 6 times within 2-month inmedical history before screening period.

5. Seizure number had been recorded at least 3 times within 28-day screening period.

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

Exclusion Criteria:

1. Patients with concurrent active psychiatric or mood disorders that in the opinion ofthe investigator would interfere with participation in the study.

2. Presence of pacemaker, implantable cardioverter-defibrillator (ICD), permanentmedication pumps, cochlear implants, or deep brain stimulation (DBS)

3. The skull bone area traversed by the sonication pathway is covered by scars, scalpdisorders (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:

6. Platelet (PLT) < 100,000/μL.

7. prothrombin time (PT) >14 sec.

8. activated partial thromboplastin time (APTT) >36 sec.

9. and international normalized ratio (INR) > 1.3.

10. Pregnant or breast-feeding women.

11. Coexisting medical problems of sufficient severity to limit compliance with thestudy.

12. Known sensitivity/allergy to Magnetic Resonance Imaging (MRI) contrast agents or anyof its components.

13. Use of any recreational drugs or history of drug addiction or known history ofsubstance or alcohol abuse.

14. Patients have received an investigational drug or an investigational device within 4weeks prior to the study.

15. Any other condition that, in the investigator's judgment, might affect studyendpoints or might increase the risk to the patients or decrease the chance ofobtaining satisfactory data needed to achieve the objectives of the study.

16. Any ASM treatment change during the baseline (screening period)

17. Vagus nerve stimulation (VNS) dosing changes within 2 months before baseline (screening period).

18. Radiofrequency thermocoagulation (RFTC) within 2 months before baseline (screeningperiod).

19. Any other condition that, in the investigator's judgment, patient not applicable toparticipate this study.