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

Inclusion Criteria:

1. Male or female patients aged over than and equal to 18 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. Epileptogenic focus (or foci) is determined by comprehensive presurgical evaluation.

4. At least 4 focal-onset seizures with objectively visible or significantly disablingmanifestations in the 8-week baseline and at least one seizure per month in thebaseline.

5. 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 have beenassessed to 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), wounds, or atrophy of the scalp.

4. Image documented calcified lesion in the FUS exposure path.

5. Abnormal coagulation profile:

6. Platelet (PLT) < 100,000/μL.

7. prothrombin time (PT) > 15 sec.

8. activated partial thromboplastin time (APTT) > 45 sec.

9. international normalized ratio (INR) > 1.5.

10. Patients requiring anticoagulant medications.

11. Pregnant or breast-feeding women.

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

13. Known sensitivity/allergy to Magnetic Resonance Imaging (MRI) contrast agents or anyof its components; having metallic implants that are assessed as unsuitable for MRIexamination.

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

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

16. 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.

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

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

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

20. Patient has an IQ < 70, based on the Wechsler Abbreviated Scale of Intelligence (WASI-III or IV).

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