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

April 6, 2026 updated by: NaviFUS Corporation

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 will be a prospective, pilot, open-label, two-arm, parallel-group, randomized study to evaluate the efficacy and safety of low-intensity focused ultrasound (LIFU) neuromodulation using NaviFUS System in patients with drug-resistant epilepsy (DRE).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study aims to demonstrate the efficacy and safety of LIFU neuromodulation in DRE patients, showing its ability to decrease targeted neuronal activity and alleviate epileptic seizures.

Drug-resistant epilepsy (at least 3 anti-seizure medication failed) patients whose epileptogenic foci have been determined by comprehensive presurgical evaluation and meet all eligibility criteria may participate in this study by providing informed consent. Eligible patients will undergo a 8-week baseline observation screening period and will be asked to keep a 8-week seizure diary. This diary will serve as a baseline prior to treatment and will continue to be recorded throughout the treatment and follow-up period.

This study will enroll a maximum of 16 eligible patients. Eligible patients will be randomized into two groups to receive three-consecutive 5-minute twice (low dose group) or three-consecutive 10-minute FUS treatment twice (high dose group) in a week using assigned ultrasound exposure doses generated by the NaviFUS System. Following treatment, there will be a 24-week follow-up period. Patients will be allowed concomitant use of anti-seizure medications (ASMs) throughout the whole study period.

Study Type

Interventional

Enrollment (Estimated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:
          • Hsiang-Yu Yu, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low dose group FUS treatment

FUS treatment will be conducted with following exposure parameters:

intracranial spatial-peak temporal-average intensity (ISPTA) ceiling level: 2.8 W/cm2, burst length: 3 ms, duration: three consecutive 5-minute FUS exposures with two 5-minute intermission intervals.
Device: Focused ultrasound (FUS) treatment
The mechanism of action of FUS neuromodulation involves the activation of voltage-gated ion channels to induce temporary neuromodulation.
Experimental: High dose group FUS treatment

FUS treatment will be conducted with following exposure parameters:

intracranial spatial-peak temporal-average intensity (ISPTA) ceiling level: 2.8 W/cm2, burst length: 3 ms, duration: three consecutive 10-minute FUS exposures with two 5-minute intermission intervals.
Device: Focused ultrasound (FUS) treatment
The mechanism of action of FUS neuromodulation involves the activation of voltage-gated ion channels to induce temporary neuromodulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of seizure frequency after treatment compared to baseline
Time Frame: up to 33 weeks
The changes in patient's seizure frequency from baseline through the study completion will be assessed based on the seizure diaries.
up to 33 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Responder rate (≧50% seizure reduction)
Time Frame: up to 33 weeks
The changes in responder rate (≧50% seizure reduction) from baseline through the study completion will be assessed based on the seizure diaries.
up to 33 weeks
Change from baseline in number of seizure-free days
Time Frame: up to 33 weeks
The changes in number of seizure-free days from baseline through the study completion will be assessed based on the seizure diaries.
up to 33 weeks
Change from baseline in subjective seizure strength
Time Frame: up to 33 weeks
The changes in subjective seizure strength from baseline through the study completion will be assessed based on the seizure diaries.
up to 33 weeks
Quality of Life in Epilepsy (QOLIE-31)
Time Frame: up to 33 weeks
The QOLIE-31 is a survey of health-related quality of life for adults with epilepsy. There are 31 questions about patient's health and daily activities. The total score is calculated as a weighted mean of the sub-scale scores and the scoring of the QOLIE-31 requires the conversion of raw data to a scale of 0 to 100 for each sub-scale, with higher scores reflecting higher quality of life.
up to 33 weeks
Changes of Beck Anxiety Inventory (BAI) after treatment compared to baseline
Time Frame: up to 33 weeks
BAI is a 21-question multiple-choice self-report inventory that is used to measure the severity of anxiety. Each answer is scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms.
up to 33 weeks
Changes of Beck Depression Inventory (BDI) after treatment compared to baseline
Time Frame: up to 33 weeks
BDI-II, a 21-question multiple-choice self-report inventory, is a psychological test used to measure the severity of depression. Each answer is rated on a scale of 0 (none at all) to 3 (severe). Higher total scores indicate more severe depressive symptoms.
up to 33 weeks
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: up to 33 weeks
The incidence and severity of AEs associated with LIFU neuromodulation in patients with DRE.
up to 33 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NaviFUS Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

July 1, 2024

First Submitted That Met QC Criteria

July 1, 2024

First Posted (Actual)

July 9, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NF-2023-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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