Sound waves vs. seizures: new ultrasound treatment tested for epilepsy
NCT ID NCT07591350
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
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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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About 13 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 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. 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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