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Sound waves vs. seizures: new ultrasound treatment tested for epilepsy

NCT ID NCT07591350

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether MRI-guided high-intensity focused ultrasound (HIFU) can safely and effectively treat drug-resistant focal epilepsy in 13 adults. The procedure uses focused sound waves to heat and destroy small brain lesions causing seizures, without needing open surgery. Researchers will check if the target temperature is reached and monitor for complications over 12 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MRI-guided high-intensity focused ultrasound (HIFU) thermoablation
What this could lead to
If successful, this could offer a non-surgical option to control seizures in people with drug-resistant epilepsy who cannot have traditional brain surgery.
What could go wrong
This is a very small, early pilot study with only 13 participants, so results may not apply widely. The procedure may not safely reach the target temperature or could cause complications.

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

About 13 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 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. Age ≥18 years old 2. Patient with drug-resistant epilepsy according to ILAE definition 3. Patient presenting lesional image(s) on morphological MRI responsible for epilepsy according to clinical and electrophysiological evaluation, +/-PET+/- SPECT+/-sEEG 4. Patients for whom neurosurgical treatment by craniotomy is not possible: deep-seated lesions, lesions in the eloquent area, patient reluctance to have a surgical procedure with craniotomy, contraindication to general anesthesia 5. Patient affiliated to a social security scheme 6. The patients signed an informed consent form. Exclusion Criteria: 1. Drug-sensitive epilepsy 2. Patients exhibiting suboptimal adherence to medication 3. Individuals under legal protective measures 4. Patients presenting contraindications to Magnetic Resonance Imaging (MRI), such as the presence of metal fragments, allergy to gadolinium, etc. 5. Patients with serious and uncontrolled psychiatric disorders 6. Pregnant women. Women of reproductive capacity were mandated to use oral contraceptives throughout the study duration. 7. Contraindications related to ExAblate treatment: * patients with implants in the brain or skull. * patients where it is not possible to avoid energy-absorbing structures or sensitive tissues (e.g., skull density ratio \<0.35, areas of anterior brain shunts, surgical clamps, or other hard implants) on the path of the ultrasound beam. * patients diagnosed with another brain disease (e.g., malignant brain tumors or intracranial aneurysms). * patients with a history of cerebral hemorrhage, and stroke within the last year. * patients taking medications that are predisposed to bleeding and have not stopped for two weeks before the procedure. * patients with severe hypertension that cannot be controlled with medication (diastolic blood pressure \>100 mmHg). * patients who could not communicate with the physician during the treatment. * patients with unstable cardiac conditions. * patients with history of abnormal bleeding, intracranial hemorrhage, coagulopathy, or documented risk factors for intraoperative or postoperative bleeding or coagulopathy. * patients with cerebrovascular disease (multiple strokes or strokes within six months). * patients with risk factors for intraoperative or postoperative bleeding. * patients with significant healing in an area located on the path of the intended passage of energy to the treatment area.

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Conditions

The condition(s) this trial relates to.

Drug Resistant Epilepsy epilepsy

As listed by the trial registrant

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

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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