Evaluating a new ultrasound treatment for drug-resistant epilepsy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Taipei Veterans General Hospital
  Taipei, Taiwan Recruiting

Study contacts

• Study coordinator: Sheang-Tze Fung, Ph.D.
• Email: stfung@navifus.com
• Phone: 02-25860560

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Low-intensity focused ultrasound treatment for drug-resistant epilepsy

  This study is testing if low-intensity focused ultrasound can help people with drug-resistant temporal lobe epilepsy have fewer seizures while they continue taking their regular medications.

  Recruiting at 3 sites Phase 1/2 NaviFUS Corporation · Palo Alto, California and 2 other locations · NCT06388707

• Non-Invasive Low Intensity Focused Ultrasound Stimulation for Drug-Resistant Epilepsy

  This study tests whether low intensity focused ultrasound can help reduce seizures in adults with drug‑resistant epilepsy.

  Recruiting University of California, San Francisco · San Francisco, California · NCT07680842

• PET‑MRI mapping of brainstem serotonin pathways in adults with Dravet syndrome

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  Recruiting Hospices Civils de Lyon · Bron, Rhone · NCT07013331

• Gut–brain microbiota link in new‑onset and drug‑resistant epilepsy

  This project will see if gut bacteria and their chemical products are linked to how well people with new‑onset or drug‑resistant epilepsy do after surgery, vagus‑nerve stimulation, or a ketogenic diet.

  Recruiting Niguarda Hospital · Milan, Lombardy · NCT07010445

• Personalized electrical stimulation for drug-resistant epilepsy

  This study is testing if a personalized electrical stimulation treatment can help people with drug-resistant epilepsy have fewer seizures and improve their quality of life.

  Recruiting at 3 sites Assistance Publique Hopitaux De Marseille · Bordeaux and 6 other locations · NCT06334952

• Using focused ultrasound to treat drug-resistant epilepsy

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

  Recruiting Genovate Biotechnology Co., Ltd., · Melbourne, Victoria · NCT05947656

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.