Idiopathic Generalized EpilepsyHIFU for MRGENCT07803692
High-Intensity Focused Ultrasonic Ablation of the Centromedian Thalamic Nucleus for Treatment of Medically Refractory Generalized Epilepsy in Patients Ages 18 Years to 89 Years
A study testing Intervention 1 and Intervention 2 in people with Idiopathic Generalized Epilepsy, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of this study is to find out if magnetic resonance (MRI)-guided high-intensity focused ultrasound (HIFU) is safe and effective for treating medically refractory generalized epilepsy. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Idiopathic Generalized Epilepsy
- What is being tested?
- Intervention 1 and Intervention 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2027to Jun 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18 years to 89 years.
- Adult males or females, non-pregnant, on reliable contraceptive regimen as appropriate.
- Patient and legal representative as appropriate capable of signing written informed consent, completing electronic seizure diary, participating in questionnaires.
- 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.
- 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.
- 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.
Who cannot join
- 1. Pregnancy.
- Unable or unwilling to comply with inclusion criteria as described.
- Prior disqualifying medical or surgical history:
- Patients with advanced kidney disease or on dialysis
- Patients with unstable cardiac status:
- 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
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- Patients who are not candidates for HIFU.
- Patients who have an Overall Skull Density Ratio of 0.40 (±0.05) or less as calculated from the screening CT
- Patients with standard contraindications for MRI such as non-MRI compatible implanted devices including cardiac pacemakers, size limitations, etc.
- Inability to tolerate MRI without premedication, sedation, or anesthesia.
- Known intolerance or allergies to MRI contrast agent (e.g. Gadolinium or Magnevist)
- History of craniotomy or other prior cranial procedure that would render phase correction with CT inaccurate.
- Subjects with risk factors for intraoperative or postoperative bleeding:
- Platelet count less than 100,00 per cubic millimeter
- INR coagulation studies exceeding local institution laboratory standards
- Documented coagulopathy
- Subject with life-threatening systemic disease that include and not limited to the following: HIV, liver failure, blood dyscrasias, etc.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
Michael T McGehee, MS, 503-494-4988, nsgclinicalresearch@ohsu.edu
Ahmed Raslan, MD
About this study
Official title: High-Intensity Focused Ultrasonic Ablation of the Centromedian Thalamic Nucleus for Treatment of Medically Refractory Generalized Epilepsy
The purpose of this study is to find out if magnetic resonance (MRI)-guided high-intensity focused ultrasound (HIFU) is safe and effective for treating medically refractory generalized epilepsy. HIFU is a procedure that delivers ultrasonic waves to brain regions with great precision to remove tissue that may cause problems. HIFU is approved by the Federal Drug Administration (FDA) for treating patients with essential tremor.
This study aims to find out if HIFU can safely reduce seizure burden in patients with medically refractory generalized epilepsy (MRGE) using metrics commonly used in other treatments for epilepsy, and by the change in frequency of convulsive (generalized tonic-clonic) seizures before and after the intervention.
Read the detailed description
The primary purpose of this study is to evaluate the safety of thalamotomy targeting the centromedian thalamic nucleus (CMN) using magnetic resonance-guided high-intensity focused ultrasound (HIFU), an incisionless, ablative procedure that selectively delivers ultrasonic waves to brain regions with submillimeter precision, which is already FDA-approved for thalamotomy in essential tremor and in practice at many institutions, including that of the investigators. The proposed study aims to determine if ablation of CMN using HIFU can safely reduce generalized seizure burden in patients with medically refractory generalized epilepsy (MRGE) using success metrics commonly used in interventions for epilepsy and by the change in frequency of convulsive (generalized tonic-clonic) seizures before and after the intervention.
Current literature suggests that thalamotomy with HIFU for essential tremor produces minimal and generally transient side effects, while targeted lesioning of CMN with other modalities such as radiofrequency ablation (RFA) produces similarly transient side effects in patients with MRGE. No mortality associated with treatment was reported in any study. Furthermore, the benefits for this patient population from RFA or from deep brain stimulation (DBS) of CMN ranged from 50-98% reduction in generalized seizures as long as 36 months post-operatively. Thus, the investigators hypothesize that HIFU ablation of CMN will safely produce a similar durable reduction in generalized seizure burden for patients with MRGE.
In the proposed study, patients will be evaluated for three months pre-intervention and followed for one year after Intervention 1. The same schedule will be followed by subjects who proceed to receive Intervention 2.
Seizure freedom will be defined according to the International League Against Epilepsy (ILAE) outcome classification scale. The ILAE outcome scale includes six classes of outcome: Class 1 = seizure free; Class 2 = auras only; Class 3 = one to three seizure days/year and auras; Class 4 = four seizure days/year to 50% reduction in baseline and auras; Class 5 = <50% reduction in baseline number of seizure days to 100% increase in baseline number of seizure days and auras; Class 6 = >100% increase in baseline number of seizure days and auras. Only patients classified as ILAE Class 1 or Class 2 will be considered seizure-free.
This is a proof-of-concept interventional study whose primary aims are as follows:
Primary Aim 1: To characterize the safety of bilateral CMN ablation using HIFU in terms of both somatic and neuropsychological adverse events.
Primary Aim 2: To determine the efficacy of bilateral CMN ablation using HIFU in reducing generalized seizure burden and effect on interictal Electroencephalogram (EEG) anomalies.
- Conditions
- Idiopathic Generalized Epilepsy
- Being tested
- Intervention 1, Intervention 2
- Keywords
- generalized epilepsy, HIFU, High Intensity Focused Ultrasound, epilepsy, seizure
- Medical subject headings
- Epilepsy, Idiopathic Generalized, Epilepsy, Generalized, Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention 1Device
HIFU ablation of dominant-hemisphere centromedian thalamic nucleus (CMN), or dominant seizure activity hemisphere
Intervention 2Device
HIFU ablation of contralateral centromedian thalamic nucleus (CMN)
| Study group | Role | What they receive |
|---|---|---|
| Intervention 1 | Experimental | Ten patients will undergo unilateral HIFU treatment of the dominant hemisphere CMN (Intervention 1). Safety follow-up visits will take place at 2-weeks, 1-month, 3-months, 6-months, 9-months, and 1-year post-treatment to assess for persistent clinically relevant adverse events (AEs) and any AEs related to HIFU treatment. A seizure severity assessment will also be performed at these follow-up visits. Seizure freedom will be defined according to the ILAE classification, with only patients in ILAE classes 1 or 2 considered seizure-free.
At the 1-year follow-up visit, patients who have not experienced persistent clinically relevant AEs related to HIFU treatment, and who are not seizure-free according to the ILAE classification, will proceed to second-side HIFU treatment of the CMN (Intervention 2) after an additional three-month pre-second-side evaluation. Patients who are seizure-free according to the ILAE classification after unilateral treatment, or who develop clinically relevant ad Receives: Device: Intervention 1 |
| Intervention 2 | Experimental | At the 1-year follow-up visit (for Intervention 1 - unilateral HIFU treatment of CMN), patients who have not experienced persistent clinically relevant AEs related to HIFU treatment, and who are not seizure-free according to the ILAE classification, will proceed to second-side HIFU treatment of the CMN (Intervention 2) after an additional three-month pre-second-side evaluation. Patients who are seizure-free according to the ILAE classification after unilateral treatment, or who develop clinically relevant adverse events (AEs) and any AEs related to HIFU treatment, will not undergo second-side treatment and will exit the study after the 1-year follow-up visit. Receives: Device: Intervention 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Number of participants with device-related or procedure-related serious adverse events (SAEs) such as deaths, hospitalizations, or life-threatening events as assessed by CTCAE v5.0.
Measured: From enrollment to 1 year following treatment
Secondary outcomes (1)
Seizure Frequency and Severity
Number of participants with decreased seizure frequency or severity as assessed according to the ILAE classification.
Measured: From enrollment to 1 year following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study startFeb 2027 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Generalized EpilepsyStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Exablate 4000 Type 1.0 and Type 1.1
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- InSightec
- Responsible party
- Principal investigator, Ahmed Raslan, Oregon Health and Science University
- Investigators
- Ahmed Raslan, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07803692
- Sponsor's protocol ID
- STUDY00027836
- Acronym
- HIFU for MRGE
- Status last verified
- Jul 2026
- First submitted
- 10 Aug 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: IPD will be shared via secure GitHub folder, which will be provided at time of manuscript submission.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Intensity Focused Ultrasonic Ablation of the Centromedian Thalamic Nucleus for Treatment of Medically Refractory Generalized Epilepsy
- ClinicalTrials.gov ID
- NCT07803692
- Acronym / sponsor ID
- HIFU for MRGE / STUDY00027836
- Conditions
- Idiopathic Generalized Epilepsy
- Keywords
- generalized epilepsy, HIFU, High Intensity Focused Ultrasound, epilepsy, seizure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- InSightec
- Study start
- Feb 2027 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out if magnetic resonance (MRI)-guided high-intensity focused ultrasound (HIFU) is safe and effective for treating medically refractory generalized epilepsy. HIFU is a procedure that delivers ultrasonic waves to brain regions with great precision to remove tissue that may cause problems. HIFU is approved by the Federal Drug Administration (FDA) for treating patients with essential tremor.
This study aims to find out if HIFU can safely reduce seizure burden in patients with medically refractory generalized epilepsy (MRGE) using metrics commonly used in other treatments for epilepsy, and by the change in frequency of convulsive (generalized tonic-clonic) seizures before and after the intervention.
Detailed description
The primary purpose of this study is to evaluate the safety of thalamotomy targeting the centromedian thalamic nucleus (CMN) using magnetic resonance-guided high-intensity focused ultrasound (HIFU), an incisionless, ablative procedure that selectively delivers ultrasonic waves to brain regions with submillimeter precision, which is already FDA-approved for thalamotomy in essential tremor and in practice at many institutions, including that of the investigators. The proposed study aims to determine if ablation of CMN using HIFU can safely reduce generalized seizure burden in patients with medically refractory generalized epilepsy (MRGE) using success metrics commonly used in interventions for epilepsy and by the change in frequency of convulsive (generalized tonic-clonic) seizures before and after the intervention.
Current literature suggests that thalamotomy with HIFU for essential tremor produces minimal and generally transient side effects, while targeted lesioning of CMN with other modalities such as radiofrequency ablation (RFA) produces similarly transient side effects in patients with MRGE. No mortality associated with treatment was reported in any study. Furthermore, the benefits for this patient population from RFA or from deep brain stimulation (DBS) of CMN ranged from 50-98% reduction in generalized seizures as long as 36 months post-operatively. Thus, the investigators hypothesize that HIFU ablation of CMN will safely produce a similar durable reduction in generalized seizure burden for patients with MRGE.
In the proposed study, patients will be evaluated for three months pre-intervention and followed for one year after Intervention 1. The same schedule will be followed by subjects who proceed to receive Intervention 2.
Seizure freedom will be defined according to the International League Against Epilepsy (ILAE) outcome classification scale. The ILAE outcome scale includes six classes of outcome: Class 1 = seizure free; Class 2 = auras only; Class 3 = one to three seizure days/year and auras; Class 4 = four seizure days/year to 50% reduction in baseline and auras; Class 5 = <50% reduction in baseline number of seizure days to 100% increase in baseline number of seizure days and auras; Class 6 = >100% increase in baseline number of seizure days and auras. Only patients classified as ILAE Class 1 or Class 2 will be considered seizure-free.
This is a proof-of-concept interventional study whose primary aims are as follows:
Primary Aim 1: To characterize the safety of bilateral CMN ablation using HIFU in terms of both somatic and neuropsychological adverse events.
Primary Aim 2: To determine the efficacy of bilateral CMN ablation using HIFU in reducing generalized seizure burden and effect on interictal Electroencephalogram (EEG) anomalies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Exablate 4000 Type 1.0 and Type 1.1
| Arm | Type | Receives |
|---|---|---|
| Intervention 1 | Experimental | Device: Intervention 1Ten patients will undergo unilateral HIFU treatment of the dominant hemisphere CMN (Intervention 1). Safety follow-up visits will take place at 2-weeks, 1-month, 3-months, 6-months, 9-months, and 1-year post-treatment to assess for persistent clinically relevant adverse events (AEs) and any AEs related to HIFU treatment. A seizure severity assessment will also be performed at these follow-up visits. Seizure freedom will be defined according to the ILAE classification, with only patients in ILAE classes 1 or 2 considered seizure-free. At the 1-year follow-up visit, patients who have not experienced persistent clinically relevant AEs related to HIFU treatment, and who are not seizure-free according to the ILAE classification, will proceed to second-side HIFU treatment of the CMN (Intervention 2) after an additional three-month pre-second-side evaluation. Patients who are seizure-free according to the ILAE classification after unilateral treatment, or who develop clinically relevant ad |
| Intervention 2 | Experimental | Device: Intervention 2At the 1-year follow-up visit (for Intervention 1 - unilateral HIFU treatment of CMN), patients who have not experienced persistent clinically relevant AEs related to HIFU treatment, and who are not seizure-free according to the ILAE classification, will proceed to second-side HIFU treatment of the CMN (Intervention 2) after an additional three-month pre-second-side evaluation. Patients who are seizure-free according to the ILAE classification after unilateral treatment, or who develop clinically relevant adverse events (AEs) and any AEs related to HIFU treatment, will not undergo second-side treatment and will exit the study after the 1-year follow-up visit. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ages 18 years to 89 years.
- Adult males or females, non-pregnant, on reliable contraceptive regimen as appropriate.
- Patient and legal representative as appropriate capable of signing written informed consent, completing electronic seizure diary, participating in questionnaires.
- 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.
- 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.
Key exclusion criteria (17 listed)
- 1. Pregnancy.
- Unable or unwilling to comply with inclusion criteria as described.
- Prior disqualifying medical or surgical history:
- Patients who are not candidates for HIFU.
- Patients with standard contraindications for MRI such as non-MRI compatible implanted devices including cardiac pacemakers, size limitations, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention 1HIFU ablation of dominant-hemisphere centromedian thalamic nucleus (CMN), or dominant seizure activity hemisphere | Device | Intervention 1 |
| Intervention 2HIFU ablation of contralateral centromedian thalamic nucleus (CMN) | Device | Intervention 2 |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: From enrollment to 1 year following treatment
Number of participants with device-related or procedure-related serious adverse events (SAEs) such as deaths, hospitalizations, or life-threatening events as assessed by CTCAE v5.0.
1 secondary outcome
Seizure Frequency and Severity
Time frame: From enrollment to 1 year following treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Centromedian Nucleus of the Thalamus Deep Brain Stimulation for Genetic Generalized Epilepsy: A Case Report and Review of LiteratureLink provided by the sponsor.
- Radiofrequency ablation of the centromedian thalamic nucleus in the treatment of drug-resistant epilepsyLink provided by the sponsor.
- Centromedian thalamic nucleus with or without anterior thalamic nucleus deep brain stimulation for epilepsy in children and adults: A retrospective case seriesLink provided by the sponsor.
- The centromedian nucleus: Anatomy, physiology, and clinical implications.Link provided by the sponsor.
- Optimally targeting the centromedian nucleus of the thalamus for generalized epilepsy: A meta-analysisLink provided by the sponsor.
- Imaging the Centromedian Thalamic Nucleus Using Quantitative Susceptibility Mapping.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD will be shared via secure GitHub folder, which will be provided at time of manuscript submission.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmed Raslan, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention 1 and Intervention 2 in people with Idiopathic Generalized Epilepsy, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael McGehee, MS (971-509-4932, nsgclinicalresearch@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: From enrollment to 1 year following treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.