Sound waves aimed at the brain could tame tough seizures
NCT ID NCT04999046
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This pilot study tested a device called NaviFUS that uses focused ultrasound to stimulate the brain in 12 adults with drug-resistant epilepsy. The goal was to see if it is safe and can reduce seizure frequency. Participants kept seizure diaries and reported any side effects over two months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- focused ultrasound (NaviFUS system)
- What this could lead to
- If it works, this could point toward a non-invasive treatment option for people with epilepsy that doesn't respond to medication.
- What could go wrong
- This is a very small pilot study with only 12 participants, so results may not apply to everyone. The treatment is still experimental and its long-term safety and effectiveness are not yet proven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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12 people
The number who actually took part.
- Started
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Oct 2021
- Finished
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Jul 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female patients aged ≥20 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. An epileptogenic foci is determined by comprehensive presurgical evaluation 4. Seizure number is countable and had been recorded at least 6 times within 2-month in medical history before screening period. 5. Seizure number had been recorded at least 3 times within 28-day screening period. 6. 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 in the opinion of the investigator would 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), or atrophy of the scalp. 4. Clips or other metallic implanted objects in the FUS exposure path, except shunts. 5. Abnormal coagulation profile: 1. Platelet (PLT) \< 100,000/μL. 2. prothrombin time (PT) \>14 sec. 3. activated partial thromboplastin time (APTT) \>36 sec. 4. and international normalized ratio (INR) \> 1.3. 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. 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. Any other condition that, in the investigator's judgment, patient not applicable to participate this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Taipei Veterans General Hospital
Taipei, 11217, Taiwan
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