Drug Resistant EpilepsyNCT06492720
A Pilot Study to Evaluate the Efficacy and Safety of NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy
A study testing Focused ultrasound (FUS) treatment in people with Drug Resistant Epilepsy and Epilepsy, run by NaviFUS Corporation at 1 site in Taiwan.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Drug Resistant Epilepsy, Epilepsy, Epilepsy, Temporal Lobe
- What is being tested?
- Focused ultrasound (FUS) treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2024to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged over than and equal to 18 years old.
- Patients with drug-resistant epilepsy (defined as at least 3 ASM failed) and 1-4 ASM at the time of study entry.
- Epileptogenic focus (or foci) is determined by comprehensive presurgical evaluation.
- 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.
- Willing and able to sign written informed consent and be able to comply with the study protocol during the study period.
Who cannot join
- Patients with concurrent active psychiatric or mood disorders that have been assessed to interfere with participation in the study.
- Presence of pacemaker, implantable cardioverter-defibrillator (ICD), permanent medication pumps, cochlear implants, or deep brain stimulation (DBS).
- The skull bone area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), wounds, or atrophy of the scalp.
- Image documented calcified lesion in the FUS exposure path.
- Abnormal coagulation profile:
- Platelet (PLT) < 100,000/μL.
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- prothrombin time (PT) > 15 sec.
- activated partial thromboplastin time (APTT) > 45 sec.
- international normalized ratio (INR) > 1.5.
- Patients requiring anticoagulant medications.
- Pregnant or breast-feeding women.
- Coexisting medical problems of sufficient severity to limit compliance with the study.
- 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.
- Use of any recreational drugs or history of drug addiction or known history of substance or alcohol abuse.
- Patients have received an investigational drug or an investigational device within 4 weeks prior to the study
- 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.
- Any ASM treatment change during the baseline (screening period).
- Vagus nerve stimulation (VNS) dosing changes within 2 months before baseline (screening period).
- Radiofrequency thermocoagulation (RFTC) within 2 months before baseline (screening period).
- Patient has an IQ < 70, based on the Wechsler Abbreviated Scale of Intelligence (WASI-III or IV).
- Any other condition that, in the investigator's judgment, patient not applicable to participate this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Arthur Lung, Ph.D. contact
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei
Hsiang-Yu Yu, M.D.
About this study
Official title: 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).
Read the 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.
- Being tested
- Focused ultrasound (FUS) treatment
- Keywords
- NaviFUS System, Focused Ultrasound, Low-Intensity Focused Ultrasound, LIFU
- Medical subject headings
- Drug Resistant Epilepsy, Epilepsy, Epilepsy, Temporal Lobe, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused ultrasound (FUS) treatmentDevice
The mechanism of action of FUS neuromodulation involves the activation of voltage-gated ion channels to induce temporary neuromodulation.
| Study group | Role | What they receive |
|---|---|---|
| Low dose group FUS treatment | Experimental | 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. Receives: Device: Focused ultrasound (FUS) treatment |
| High dose group FUS treatment | Experimental | 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. Receives: Device: Focused ultrasound (FUS) treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of seizure frequency after treatment compared to baseline
The changes in patient's seizure frequency from baseline through the study completion will be assessed based on the seizure diaries.
Measured: up to 33 weeks
Secondary outcomes (7)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The incidence and severity of AEs associated with LIFU neuromodulation in patients with DRE.
Measured: up to 33 weeks
Responder rate (≧50% seizure reduction)
The changes in responder rate (≧50% seizure reduction) from baseline through the study completion will be assessed based on the seizure diaries.
Measured: up to 33 weeks
Change from baseline in number of seizure-free days
The changes in number of seizure-free days from baseline through the study completion will be assessed based on the seizure diaries.
Measured: up to 33 weeks
Change from baseline in subjective seizure strength
The changes in subjective seizure strength from baseline through the study completion will be assessed based on the seizure diaries.
Measured: up to 33 weeks
Quality of Life in Epilepsy (QOLIE-31)
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.
Measured: up to 33 weeks
Changes of Beck Anxiety Inventory (BAI) after treatment compared to baseline
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.
Measured: up to 33 weeks
Changes of Beck Depression Inventory (BDI) after treatment compared to baseline
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.
Measured: up to 33 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start1 Sep 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Drug Resistant EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NaviFUS Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492720
- Sponsor's protocol ID
- NF-2023-02
- Status last verified
- Apr 2026
- First submitted
- 1 Jul 2024
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen SG, Tsai CH, Lin CJ, Lee CC, Yu HY, Hsieh TH, Liu HL. Transcranial focused ultrasound pulsation suppresses pentylenetetrazol induced epilepsy in vivo. Brain Stimul. 2020 Jan-Feb;13(1):35-46. doi: 10.1016/j.brs.2019.09.011. Epub 2019 Sep 24.
PubMed 31575487Chu PC, Yu HY, Lee CC, Fisher R, Liu HL. Pulsed-Focused Ultrasound Provides Long-Term Suppression of Epileptiform Bursts in the Kainic Acid-Induced Epilepsy Rat Model. Neurotherapeutics. 2022 Jul;19(4):1368-1380. doi: 10.1007/s13311-022-01250-7. Epub 2022 May 17.
PubMed 35581489Lee CC, Chou CC, Hsiao FJ, Chen YH, Lin CF, Chen CJ, Peng SJ, Liu HL, Yu HY. Pilot study of focused ultrasound for drug-resistant epilepsy. Epilepsia. 2022 Jan;63(1):162-175. doi: 10.1111/epi.17105. Epub 2021 Nov 2.
PubMed 34729772
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06492720
- Acronym / sponsor ID
- NF-2023-02
- Keywords
- NaviFUS System, Focused Ultrasound, Low-Intensity Focused Ultrasound, LIFU
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- NaviFUS CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 9 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose group FUS treatment | Experimental | Device: Focused ultrasound (FUS) treatmentFUS 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. |
| High dose group FUS treatment | Experimental | Device: Focused ultrasound (FUS) treatmentFUS 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients aged over than and equal to 18 years old.
- Patients with drug-resistant epilepsy (defined as at least 3 ASM failed) and 1-4 ASM at the time of study entry.
- Epileptogenic focus (or foci) is determined by comprehensive presurgical evaluation.
- 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.
- Willing and able to sign written informed consent and be able to comply with the study protocol during the study period.
Key exclusion criteria (21 listed)
- Patients with concurrent active psychiatric or mood disorders that have been assessed to interfere with participation in the study.
- Presence of pacemaker, implantable cardioverter-defibrillator (ICD), permanent medication pumps, cochlear implants, or deep brain stimulation (DBS).
- The skull bone area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), wounds, or atrophy of the scalp.
- Image documented calcified lesion in the FUS exposure path.
- Abnormal coagulation profile:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focused ultrasound (FUS) treatmentThe mechanism of action of FUS neuromodulation involves the activation of voltage-gated ion channels to induce temporary neuromodulation. | Device | High dose group FUS treatment, Low dose group FUS treatment |
Primary outcome
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.
7 secondary outcomes
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: up to 33 weeks
Responder rate (≧50% seizure reduction)
Time frame: up to 33 weeks
Change from baseline in number of seizure-free days
Time frame: up to 33 weeks
Change from baseline in subjective seizure strength
Time frame: up to 33 weeks
Quality of Life in Epilepsy (QOLIE-31)
Time frame: up to 33 weeks
Changes of Beck Anxiety Inventory (BAI) after treatment compared to baseline
Time frame: up to 33 weeks
Changes of Beck Depression Inventory (BDI) after treatment compared to baseline
Time frame: up to 33 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Background: PubMed 31575487Chen SG, Tsai CH, Lin CJ, Lee CC, Yu HY, Hsieh TH, Liu HL. Transcranial focused ultrasound pulsation suppresses pentylenetetrazol induced epilepsy in vivo. Brain Stimul. 2020 Jan-Feb;13(1):35-46. doi: 10.1016/j.brs.2019.09.011. Epub 2019 Sep 24.
- Background: PubMed 35581489Chu PC, Yu HY, Lee CC, Fisher R, Liu HL. Pulsed-Focused Ultrasound Provides Long-Term Suppression of Epileptiform Bursts in the Kainic Acid-Induced Epilepsy Rat Model. Neurotherapeutics. 2022 Jul;19(4):1368-1380. doi: 10.1007/s13311-022-01250-7. Epub 2022 May 17.
- Background: PubMed 34729772Lee CC, Chou CC, Hsiao FJ, Chen YH, Lin CF, Chen CJ, Peng SJ, Liu HL, Yu HY. Pilot study of focused ultrasound for drug-resistant epilepsy. Epilepsia. 2022 Jan;63(1):162-175. doi: 10.1111/epi.17105. Epub 2021 Nov 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arthur Lung, Ph.D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focused ultrasound (FUS) treatment in people with Drug Resistant Epilepsy and Epilepsy, run by NaviFUS Corporation at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sheang-Tze Fung, Ph.D. (02-25860560 ext. 167, stfung@navifus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of seizure frequency after treatment compared to baseline (time frame: up to 33 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06492720, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.