Evaluating a new ultrasound treatment for drug-resistant epilepsy

A Pilot, Open-label, Two-arm, Parallel-group Randomized Trial Study to Evaluate the Efficacy and Safety of NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy

This study is testing a new ultrasound treatment for people with drug-resistant epilepsy to see if it can help reduce their seizures and improve their quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 16 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: NaviFUS Corporation (Industry-sponsored)
• Locations: 1 site (Taipei)
• Trial ID: NCT06492720 on ClinicalTrials.gov

What this trial studies

This pilot study aims to assess the efficacy and safety of the NaviFUS System, which utilizes low-intensity focused ultrasound (LIFU) neuromodulation, in patients suffering from drug-resistant epilepsy. Participants will undergo an 8-week baseline observation period, during which they will maintain a seizure diary, followed by randomization into two treatment groups receiving different ultrasound exposure doses. The study will monitor the effects of the treatment over a 24-week follow-up period, allowing for the continued use of anti-seizure medications. The goal is to demonstrate a reduction in seizure frequency and improvement in patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 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 medical implants may not benefit from this treatment.

Why it matters

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

How similar studies have performed: While focused ultrasound is a novel approach in this context, similar studies have shown promise in other neurological applications, suggesting potential for success.

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.

Where this trial is running

Taipei

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

Study contacts

• Study coordinator: Sheang-Tze Fung, Ph.D.

Conditions Drug Resistant Epilepsy; Epilepsy; Epilepsy, Temporal Lobe; Seizures, Focal; NaviFUS System; Focused Ultrasound; Low-Intensity Focused Ultrasound; LIFU