NaviFUS treatment for patients with drug-resistant epilepsy

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

This study is testing a new treatment called NaviFUS to see if it can help people with epilepsy that doesn't respond to medications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: NaviFUS Corporation (Industry-sponsored)
• Locations: 1 site (Taipei)
• Trial ID: NCT04999046 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of the NaviFUS™ system in patients suffering from drug-resistant epilepsy. It employs a pilot, single-blind, randomized crossover design at a single center, enrolling patients with identified epileptogenic foci. Participants will undergo a 28-day screening period followed by random assignment to receive either the FUS treatment or a sham treatment, with a subsequent crossover to the alternate treatment after one month. Seizure activity will be monitored through daily diaries during the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 20 and older with drug-resistant epilepsy who have failed at least three anti-seizure medications.

Not a fit: Patients with active psychiatric disorders or those with certain implanted medical devices may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new non-invasive option for patients with drug-resistant epilepsy, potentially reducing seizure frequency.

How similar studies have performed: While the approach is innovative, similar neuromodulation techniques have shown promise in other studies, suggesting potential for success.

Eligibility criteria

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 ASM at 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 in medical 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 the study protocol during the study period.

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.

Where this trial is running

Taipei

• Taipei Veterans General Hospital — Taipei, Taiwan (Recruiting)

Study contacts

• Study coordinator: Ruby Lin, Master

Conditions Drug Resistant Epilepsy