Can sound waves quiet seizures without surgery?
NCT ID NCT07803692
First seen Sep 04, 2026 · Last updated Sep 04, 2026
Summary
Researchers are testing whether MRI-guided high-intensity focused ultrasound can safely reduce seizures in adults with generalized epilepsy that does not respond to medication. The procedure uses sound waves to precisely target and ablate a small brain region involved in seizure activity. The study will track serious side effects and changes in seizure frequency and severity.
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) ablation of the centromedian thalamic nucleus
- What this could lead to
- If it works, this could offer a non-invasive option to reduce seizures in people with generalized epilepsy that medications do not control.
- What could go wrong
- The trial is small and early, and the procedure carries risks of serious side effects. It may not reduce seizures enough to be useful.
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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 10 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2027
An estimate. Start dates often move.
- Expected to finish
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Jun 2031
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 to 89 years
- 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. Ages 18 years to 89 years. 2. Adult males or females, non-pregnant, on reliable contraceptive regimen as appropriate. 3. Patient and legal representative as appropriate capable of signing written informed consent, completing electronic seizure diary, participating in questionnaires. 4. EEG features of generalized epilepsy performed within two years of enrollment with EEG anomalies not explained by contributory medical history; CT and/or MRI within the last ten years demonstrating no anatomic etiology of epilepsy. 5. MRGE, defined as persistent generalized tonic-clonic seizures, with or without concomitant absence, myoclonic, or focal seizures, despite compliance with at least two anti-seizure medications at therapeutic doses, with at least two generalized tonic-clonic seizures per month in the three months prior to HIFU procedure; must be willing to continue medication regimen during the duration of participation in the study. 6. Patient has not already undergone surgical implantation of RNS, VNS, DBS, or any other device used for management of MRGE that is not compatible with 3 Tesla MRI. Exclusion Criteria: 1. 1\. Pregnancy. 2. Unable or unwilling to comply with inclusion criteria as described. 3. Prior disqualifying medical or surgical history: 1. Patients with advanced kidney disease or on dialysis 2. Patients with unstable cardiac status: I. Unstable angina pectoris on medication II. Subjects with documented myocardial infarction within six months of protocol entry III. Significant congestive heart failure defined with ejection fraction \< 40 IV. Subjects with unstable ventricular arrhythmias V. Subjects with atrial arrhythmias that are not rate-controlled c. Patients with severe hypertension (diastolic BP\>100 on medication) d. Patients exhibiting any behavior consistent with ethanol or substance abuse e. Patients with history of abnormal bleeding, hemorrhage, and/or coagulopathy f. Patients receiving anticoagulant or drugs known to increase risk of hemorrhage within one month of focused ultrasound procedure g. Patients with cerebrovascular disease h. Patients with brain tumors i. Patients who are not able or unwilling to tolerate the required prolonged stationary position during treatment. The average treatment time (the time from the first scan to allocate transducer position and ending with the last energy delivery) is 1:56 ± 0.41 hrs (Min: 0.48 hrs, Max: 5:54 hrs) j. Patients with unstable psychiatric disease, uncontrolled depressive symptoms, psychosis, delusions, hallucinations, or suicidal ideation 4. Patients who are not candidates for HIFU. a. Patients who have an Overall Skull Density Ratio of 0.40 (±0.05) or less as calculated from the screening CT 5. Patients with standard contraindications for MRI such as non-MRI compatible implanted devices including cardiac pacemakers, size limitations, etc. 6. Inability to tolerate MRI without premedication, sedation, or anesthesia. 7. Known intolerance or allergies to MRI contrast agent (e.g. Gadolinium or Magnevist) 8. History of craniotomy or other prior cranial procedure that would render phase correction with CT inaccurate. 9. Subjects with risk factors for intraoperative or postoperative bleeding: 1. Platelet count less than 100,00 per cubic millimeter 2. INR coagulation studies exceeding local institution laboratory standards 3. Documented coagulopathy 10. Subject with life-threatening systemic disease that include and not limited to the following: HIV, liver failure, blood dyscrasias, etc.
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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 study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
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Contacts and locations
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Oregon Health & Science University
Portland, Oregon, 97239, United States
Contact Email: •••••@•••••
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