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Sound waves aimed at the brain could tame tough seizures

NCT ID NCT04999046

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

12 people

The number who actually took part.

Started

Oct 2021

Finished

Jul 2024

Lead sponsor

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

20 years and older

Sex

Anyone

Healthy volunteers

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

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.

Drug Resistant Epilepsy epilepsy visual epilepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

More trials for these conditions

Other studies related to the condition(s) this trial covers.