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

Launched by NAVIFUS CORPORATION · Jul 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option for people with drug-resistant epilepsy, which means their seizures do not respond to standard medications. Researchers are testing a device called the NaviFUS™ System, which uses low-intensity focused ultrasound to help manage seizures. The goal is to see if this treatment can reduce the frequency of seizures and if it is safe for patients to use.

To participate in this study, individuals must be at least 18 years old and have experienced at least four seizures that significantly affect their daily lives, despite trying three or more different anti-seizure medications. Participants will need to agree to follow the study rules and provide informed consent. If you join, you can expect to receive treatment with the NaviFUS™ System and be monitored closely for any effects. It’s important to know that certain conditions, like having specific medical implants or serious psychiatric issues, may make someone ineligible for the study.

Gender

ALL

Eligibility criteria

• 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 ASM at 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 disabling manifestations in the 8-week baseline and at least one seizure per month in the baseline.
• • 5. Willing and able to sign written informed consent and be able to comply with the study protocol during the study period.
• Exclusion Criteria:
• • 1. Patients with concurrent active psychiatric or mood disorders that have been assessed to 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), wounds, or atrophy of the scalp.
• • 4. Image documented calcified lesion in the FUS exposure path.
• 5. Abnormal coagulation profile:
• • 1. Platelet (PLT) \< 100,000/μL.
• • 2. prothrombin time (PT) \> 15 sec.
• • 3. activated partial thromboplastin time (APTT) \> 45 sec.
• • 4. international normalized ratio (INR) \> 1.5.
• • 5. Patients requiring anticoagulant medications.
• • 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; having metallic implants that are assessed as unsuitable for MRI examination.
• • 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. Patient has an IQ \< 70, based on the Wechsler Abbreviated Scale of Intelligence (WASI-III or IV).
• • 16. Any other condition that, in the investigator's judgment, patient not applicable to participate this study.