Drug Resistant EpilepsyNCT04999046
NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy
A study testing NaviFUS System in people with Drug Resistant Epilepsy and Seizure, run by NaviFUS Corporation at 1 site in Taiwan.
Trial summary
To evaluate the safety and efficacy of using NaviFUS™ system in patients with drug resistant epilepsy Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Drug Resistant Epilepsy, Seizure, Seizure Disorder
- What is being tested?
- NaviFUS System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Oct 2021to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged ≥20 years old.
- Patients with drug-resistant epilepsy (defined as at least 3 ASM failed) and 1-4 ASM at the time of study entry.
- An epileptogenic foci is determined by comprehensive presurgical evaluation
- Seizure number is countable and had been recorded at least 6 times within 2-month in medical history before screening period.
- Seizure number had been recorded at least 3 times within 28-day screening period.
- 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 in the opinion of the investigator would 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), or atrophy of the scalp.
- Clips or other metallic implanted objects in the FUS exposure path, except shunts.
- Abnormal coagulation profile:
- Platelet (PLT) < 100,000/μL.
Show all 19Show fewer
- prothrombin time (PT) >14 sec.
- activated partial thromboplastin time (APTT) >36 sec.
- and international normalized ratio (INR) > 1.3.
- 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.
- 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).
- 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.
About this study
Official title: A Pilot, Single Blind, Randomized Crossover Study to Evaluate the Safety and Efficacy of NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy
To evaluate the safety and efficacy of using NaviFUS™ system in patients with drug resistant epilepsy
Read the detailed description
This is a pilot, single blind, randomized crossover design, and single center. DRE patients with a determined epileptogenic foci will be enrolled. After completing the informed consent, patients will enter the 28-day screening period for baseline observation. Patients who had at least 3 seizures during the screening period will be eligible to participate the clinical trial. Eligible patients will be randomized into two groups to receive Sham treatment or FUS treatment on day 1. After FUS/Sham treatment, patients will be under home monitor to record the seizure by daily diary card for 1 month. After 1 month (Day 30±7), patients will be crossed over to the other treatment. Another one month observation will be necessary. In this trial, patients will totally receive 2 treatments: one FUS treatment, and one Sham treatment. Sixty (±7) days after day 1, patients will have a follow-up visit and overall evaluation.
- Conditions
- Drug Resistant Epilepsy, Seizure, Seizure Disorder, Epilepsy
- Being tested
- NaviFUS System
- Keywords
- focused ultrasound, LIFU, NaviFUS System
- Medical subject headings
- Drug Resistant Epilepsy, Seizures, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaviFUS SystemDevice
FUS treatment will be conducted with following exposure parameters: intracranial spatial-peak temporal-average intensity (ISPTA) ceiling level: 2.8 W/cm2 (the focused ultrasound intensity in brain area considering transcranial attenuation), burst length: 3 ms, duration: three consecutive 5-minute FUS exposures with two 5-minute intermission intervals.
| Study group | Role | What they receive |
|---|---|---|
| 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 (the focused ultrasound intensity in brain area considering transcranial attenuation), burst length: 3 ms, duration: three consecutive 5-minute FUS exposures with two 5-minute intermission intervals. The FUS exposure area will be the epileptogenic focus which is individually different and determined by standard clinical practice previously. Receives: Device: NaviFUS System |
| Sham treatment | Sham comparator | Sham treatment is to mimic the FUS treatment procedure but without any energy. The ISPTA will be 0 W/cm2, duration: three repeating 5-minute sham exposures with two 5-minute intermission intervals. Receives: Device: NaviFUS System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety during study period using the NaviFUS™ System in drug resistant epilepsy patients
The number and severity of adverse events
Measured: up to 2 months
Secondary outcomes (6)
Seizure frequency
seizure diary will be utilized during long-term (two months) home monitoring and the recording will be analyzed.
Measured: up to 2 months
Responder rate
seizure diary will be utilized during long-term (two months) home monitoring and the recording will be analyzed.
Measured: up to 2 months
Quality of Life in Epilepsy (QOLIE-31)
A survey of health-related quality of life with epilepsy.
Measured: up to 2 months
Number of seizure-free days
seizure diary will be utilized during long-term (two months) home monitoring and the recording will be analyzed.
Measured: up to 2 months
Beck Anxiety Inventory (BAI)
common symptoms of anxiety
Measured: up to 2 months
Beck Depression Inventory (BDI)
To survey patient's feeling
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start7 Oct 2021
- Primary completion13 May 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- NaviFUS Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999046
- Sponsor's protocol ID
- NF-2021-01
- Status last verified
- Apr 2026
- First submitted
- 2 Aug 2021
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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, Single Blind, Randomized Crossover Study to Evaluate the Safety and Efficacy of NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy
- ClinicalTrials.gov ID
- NCT04999046
- Acronym / sponsor ID
- NF-2021-01
- Conditions
- Drug Resistant Epilepsy, Seizure, Seizure Disorder, Epilepsy
- Keywords
- focused ultrasound, LIFU, NaviFUS System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- NaviFUS CorporationIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 13 May 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 10 Aug 2021 (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.
To evaluate the safety and efficacy of using NaviFUS™ system in patients with drug resistant epilepsy
Detailed description
This is a pilot, single blind, randomized crossover design, and single center. DRE patients with a determined epileptogenic foci will be enrolled. After completing the informed consent, patients will enter the 28-day screening period for baseline observation. Patients who had at least 3 seizures during the screening period will be eligible to participate the clinical trial. Eligible patients will be randomized into two groups to receive Sham treatment or FUS treatment on day 1. After FUS/Sham treatment, patients will be under home monitor to record the seizure by daily diary card for 1 month. After 1 month (Day 30±7), patients will be crossed over to the other treatment. Another one month observation will be necessary. In this trial, patients will totally receive 2 treatments: one FUS treatment, and one Sham treatment. Sixty (±7) days after day 1, patients will have a follow-up visit and overall evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FUS treatment | Experimental | Device: NaviFUS SystemFUS treatment will be conducted with following exposure parameters: intracranial spatial-peak temporal-average intensity (ISPTA) ceiling level: 2.8 W/cm2 (the focused ultrasound intensity in brain area considering transcranial attenuation), burst length: 3 ms, duration: three consecutive 5-minute FUS exposures with two 5-minute intermission intervals. The FUS exposure area will be the epileptogenic focus which is individually different and determined by standard clinical practice previously. |
| Sham treatment | Sham comparator | Device: NaviFUS SystemSham treatment is to mimic the FUS treatment procedure but without any energy. The ISPTA will be 0 W/cm2, duration: three repeating 5-minute sham exposures with two 5-minute intermission intervals. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients aged ≥20 years old.
- Patients with drug-resistant epilepsy (defined as at least 3 ASM failed) and 1-4 ASM at the time of study entry.
- An epileptogenic foci is determined by comprehensive presurgical evaluation
- Seizure number is countable and had been recorded at least 6 times within 2-month in medical history before screening period.
- Seizure number had been recorded at least 3 times within 28-day screening period.
Key exclusion criteria (19 listed)
- Patients with concurrent active psychiatric or mood disorders that in the opinion of the investigator would 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), or atrophy of the scalp.
- Clips or other metallic implanted objects in the FUS exposure path, except shunts.
- 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 |
|---|---|---|
| NaviFUS SystemFUS treatment will be conducted with following exposure parameters: intracranial spatial-peak temporal-average intensity (ISPTA) ceiling level: 2.8 W/cm2 (the focused ultrasound intensity in brain area considering transcranial attenuation), burst length: 3 ms, duration: three consecutive 5-minute FUS exposures with two 5-minute intermission intervals. | Device | FUS treatment, Sham treatment |
Primary outcome
Safety during study period using the NaviFUS™ System in drug resistant epilepsy patients
Time frame: up to 2 months
The number and severity of adverse events
6 secondary outcomes
Seizure frequency
Time frame: up to 2 months
Responder rate
Time frame: up to 2 months
Quality of Life in Epilepsy (QOLIE-31)
Time frame: up to 2 months
Number of seizure-free days
Time frame: up to 2 months
Beck Anxiety Inventory (BAI)
Time frame: up to 2 months
Beck Depression Inventory (BDI)
Time frame: up to 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Drug Resistant Epilepsy
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
Recruiting
Identification of Biomarkers for Vagus Nerve Stimulation in Patients With Refractory Epilepsy
Refractory Epilepsy
RecruitingPhase 1
A Phase I Clinical Trial of UX-GIP001 in the Treatment of Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy
Epilepsy
Not yet recruiting
Electrophysiological Dose-Response to Anterior Thalamic Deep Brain Stimulation in Drug-Resistant Focal Epilepsy
Drug Resistant Epilepsy, Focal Epilepsy
Recruiting
Effect of Blue Light on Vagus Nerve Stimulation in Patients With Refractory Epilepsy
Refractory Epilepsy
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NaviFUS System in people with Drug Resistant Epilepsy and Seizure, 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 6 inclusion and 19 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: finished, 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety during study period using the NaviFUS™ System in drug resistant epilepsy patients (time frame: up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.