Focused UltrasoundNCT06292494
Focused Ultrasound for Drug-resistant Epilepsy
A study testing Exablate 4000 Transcranial MRgfUS System in people with Focused Ultrasound and MR-guided FUS, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
Focused ultrasound (FUS) has been shown to differentially lesion or modulate (excite and inhibit) brain circuit and neural activity across a broad range of acoustic stimulus parameters (intensity, duty cycle, pulse repetition frequency and pulse duration) for decades. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focused Ultrasound, MR-guided FUS, Drug Refractory Epilepsy
- What is being tested?
- Exablate 4000 Transcranial MRgfUS System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2024to 31 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 and above.
- Localized refractory epilepsy (ineffective with maximum doses of two or more anti-seizure medications).
- Seizure frequency records for at least one month prior to the trial.
- Patients who have undergone a complete preoperative examination, including EEG, MRI, and positron emission tomography (PET).
- Capable of undergoing high-resolution computed tomography (CT scan), and SDR (Skull Density Ratio) ≥ 0.3.
- Must have a body type suitable for entry into the magnetic resonance imaging (MRI) machine and be able to tolerate MRI scans.
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- During the surgical procedure, communication with the physician and the expression of sensory perceptions are essential; general anesthesia is not required.
- Must be able to voluntarily press the stop button.
- Willing to undergo removal of hair from the treatment site.
Who cannot join
- This product is not suitable for individuals with contraindications related to MRI, such as those with metallic implants, those unable to undergo MRI, severe claustrophobia, or those with adverse reactions to contrast agents.
- Individuals with implants in the brain or skull, such as shunts, electrodes, hard brain membrane patches, or electrode plates, that cannot be avoided along the expected path of brain ultrasound.
- Patients along the expected path of brain ultrasound who cannot avoid structures or sensitive tissues with energy absorption (e.g., previous brain shunt surgery sites, surgical metal clips, or any hard implants).
- Patients with extensive scabbing along the expected path of brain ultrasound.
- Patients who have used contrast agents (e.g., MRI, ultrasound) within the past 24 hours before treatment.
- Patients with other high-risk brain disorders (e.g., intracranial aneurysm).
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- Patients with intraoperative or postoperative bleeding risk:
- Those with a history of cerebrovascular disease (multiple strokes or strokes within the past six months) or a history of cerebral hemorrhage and stroke.
- Those with abnormal bleeding, intracranial bleeding, coagulation disorders, or a history of bleeding or clotting disorders, either during or after surgery.
- Patients taking or injecting anticoagulant medications such as aspirin, coumadin, heparin, novel oral anticoagulants (NOACs), etc., which may lead to prolonged bleeding. Medication should be discontinued for 3-7 days before treatment.
- Patients with severe uncontrolled hypertension (systolic blood pressure > 180 mmHg after stable medication, diastolic blood pressure > 100 mmHg).
- Patients unable to communicate with the physician during the treatment process.
- Unstable cardiac conditions (heart rate > 180 beats/minute or < 40 beats/minute; systolic blood pressure > 180 mmHg or < 90 mmHg).
- Substance abuse (use of illegal drugs or using medications in a manner not recommended by a physician or manufacturer) or alcohol addiction.
- Patients who have taken medications affecting the central nervous system within the past six months (e.g., central nervous system stimulants, sympathomimetic agents).
- Patients with psychological abnormalities (e.g., schizophrenia, severe depression, bipolar disorder).
- Individuals with severe head surface injuries or potential allergies to materials in contact with the head (such as conductive gels, head silicone membranes)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei
Cheng-Chia Lee, MD. PhD., cclee12@vghtpe.gov.tw
About this study
Focused ultrasound (FUS) has been shown to differentially lesion or modulate (excite and inhibit) brain circuit and neural activity across a broad range of acoustic stimulus parameters (intensity, duty cycle, pulse repetition frequency and pulse duration) for decades. From our previous study, FUS sonication may suppress the number of epileptic signal bursts observed in EEG recordings after the induction of acute epilepsy. The presence of the suppressive effect was found in terms of the number of epileptic EEG spikes from the analysis of the unfiltered and theta-band EEG activity, and further discontinue the seizure attacks. EEG activity has also been consistently reported to have a positive correlation with the level of epilepsy, and FUS-mediated reduction of epileptic EEG activity was most notably observed, no matter lesioning or modulating effects. The aims of this study are to demonstrate the safety and efficacy of FUS technology in epilepsy patients and to estimate the optimal parameters of focused ultrasound exposure that will be used in the case of epilepsy.
- Conditions
- Focused Ultrasound, MR-guided FUS, Drug Refractory Epilepsy, Drug Resistant Epilepsy, Medication Resistant Epilepsy
- Being tested
- Exablate 4000 Transcranial MRgfUS System
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exablate 4000 Transcranial MRgfUS SystemDevice
Focused ultrasound interrupt structure of epilepsy network to improve seizure.
| Study group | Role | What they receive |
|---|---|---|
| FUS-treated epilepsy | Experimental | Not described Receives: Device: Exablate 4000 Transcranial MRgfUS System |
What is being measured
The primary outcome is the main question the study is designed to answer.
pulse rate [Safety]
vital sign
Measured: pre- and post- treatment immediately
blood oxygen saturation level [Safety]
vital sign
Measured: pre- and post- treatment immediately
MRI [Safety]
Safety and Tolerability
Measured: pre- and post- treatment immediately
Incidence of Treatment-Emergent Adverse Events [Tolerability]
To record the adverse events
Measured: during and post- treatment immediately
Secondary outcomes (3)
seizure frequency [efficacy]
The treatment response is assessed based on the overall observation of seizure frequency.
Measured: pre- and post- treatment immediately and 1,3,6,12 month
scalp EEG [efficacy]
The treatment response is assessed based on the scalp EEG (electroencephalogram).
Measured: pre- and post- treatment immediately and 1,3,6,12 month
No. of seizure-free days [efficacy]
The treatment response is assessed based on the number of seizure-free days within the entire monitoring period.
Measured: pre- and post- treatment immediately and 1,3,6,12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focused UltrasoundStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Collaborators
- InSightec
- Responsible party
- Principal investigator, Cheng-Chia Lee, Taipei Veterans General Hospital, Taiwan
- Investigators
- Cheng-Chia Lee, MD. PhD., Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06292494
- Sponsor's protocol ID
- 1129052082
- Status last verified
- Oct 2026
- First submitted
- 10 Dec 2023
- Last updated
- 16 Oct 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 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focused Ultrasound for Drug-resistant Epilepsy
- ClinicalTrials.gov ID
- NCT06292494
- Acronym / sponsor ID
- 1129052082
- Conditions
- Focused Ultrasound, MR-guided FUS, Drug Refractory Epilepsy, Drug Resistant Epilepsy, Medication Resistant Epilepsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Collaborators
- InSightec
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Mar 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.
Focused ultrasound (FUS) has been shown to differentially lesion or modulate (excite and inhibit) brain circuit and neural activity across a broad range of acoustic stimulus parameters (intensity, duty cycle, pulse repetition frequency and pulse duration) for decades. From our previous study, FUS sonication may suppress the number of epileptic signal bursts observed in EEG recordings after the induction of acute epilepsy. The presence of the suppressive effect was found in terms of the number of epileptic EEG spikes from the analysis of the unfiltered and theta-band EEG activity, and further discontinue the seizure attacks. EEG activity has also been consistently reported to have a positive correlation with the level of epilepsy, and FUS-mediated reduction of epileptic EEG activity was most notably observed, no matter lesioning or modulating effects. The aims of this study are to demonstrate the safety and efficacy of FUS technology in epilepsy patients and to estimate the optimal parameters of focused ultrasound exposure that will be used in the case of epilepsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FUS-treated epilepsy | Experimental | Device: Exablate 4000 Transcranial MRgfUS System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients aged 18 and above.
- Localized refractory epilepsy (ineffective with maximum doses of two or more anti-seizure medications).
- Seizure frequency records for at least one month prior to the trial.
- Patients who have undergone a complete preoperative examination, including EEG, MRI, and positron emission tomography (PET).
- Capable of undergoing high-resolution computed tomography (CT scan), and SDR (Skull Density Ratio) ≥ 0.3.
Key exclusion criteria (17 listed)
- This product is not suitable for individuals with contraindications related to MRI, such as those with metallic implants, those unable to undergo MRI, severe claustrophobia, or those with adverse reactions to contrast agents.
- Individuals with implants in the brain or skull, such as shunts, electrodes, hard brain membrane patches, or electrode plates, that cannot be avoided along the expected path of brain ultrasound.
- Patients along the expected path of brain ultrasound who cannot avoid structures or sensitive tissues with energy absorption (e.g., previous brain shunt surgery sites, surgical metal clips, or any hard implants).
- Patients with extensive scabbing along the expected path of brain ultrasound.
- Patients who have used contrast agents (e.g., MRI, ultrasound) within the past 24 hours before treatment.
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 |
|---|---|---|
| Exablate 4000 Transcranial MRgfUS SystemFocused ultrasound interrupt structure of epilepsy network to improve seizure. | Device | FUS-treated epilepsy |
Primary outcome
pulse rate [Safety]
Time frame: pre- and post- treatment immediately
vital sign
blood oxygen saturation level [Safety]
Time frame: pre- and post- treatment immediately
vital sign
MRI [Safety]
Time frame: pre- and post- treatment immediately
Safety and Tolerability
Incidence of Treatment-Emergent Adverse Events [Tolerability]
Time frame: during and post- treatment immediately
To record the adverse events
3 secondary outcomes
seizure frequency [efficacy]
Time frame: pre- and post- treatment immediately and 1,3,6,12 month
scalp EEG [efficacy]
Time frame: pre- and post- treatment immediately and 1,3,6,12 month
No. of seizure-free days [efficacy]
Time frame: pre- and post- treatment immediately and 1,3,6,12 month
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 16 Oct 2026.
- 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.
Cheng-Chia Lee, MD. PhD. principal investigator
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exablate 4000 Transcranial MRgfUS System in people with Focused Ultrasound and MR-guided FUS, run by Taipei Veterans General Hospital, Taiwan 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 9 inclusion and 17 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 16 Oct 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 Cheng-Chia Lee, MD. PhD. (+886-28752121 ext. 9, cclee12@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pulse rate [Safety] (time frame: pre- and post- treatment immediately). The study lists 4 primary outcomes in all. 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 16 Oct 2026.