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

NCT07803692 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: STUDY00027836
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Idiopathic Generalized Epilepsy

Keywords

generalized epilepsy; HIFU; High Intensity Focused Ultrasound; epilepsy; seizure

Outcome Measures

Primary Outcomes (1)

• Primary Aim 1

  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.

  From enrollment to 1 year following treatment

Secondary Outcomes (1)

• Primary Aim 2

  From enrollment to 1 year following treatment

Study Arms (2)

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

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.

Device: Intervention 2

Interventions

Intervention 1 DEVICE

HIFU ablation of dominant-hemisphere centromedian thalamic nucleus (CMN), or dominant seizure activity hemisphere

Intervention 1

Intervention 2 DEVICE

HIFU ablation of contralateral centromedian thalamic nucleus (CMN)

Intervention 2

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. Pregnancy.
• Prior disqualifying medical or surgical history:
• Patients with advanced kidney disease or on dialysis
• 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
• 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
• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• InSightec: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Links

• Centromedian Nucleus of the Thalamus Deep Brain Stimulation for Genetic Generalized Epilepsy: A Case Report and Review of Literature
• Radiofrequency ablation of the centromedian thalamic nucleus in the treatment of drug-resistant epilepsy
• Centromedian thalamic nucleus with or without anterior thalamic nucleus deep brain stimulation for epilepsy in children and adults: A retrospective case series
• The centromedian nucleus: Anatomy, physiology, and clinical implications.
• Optimally targeting the centromedian nucleus of the thalamus for generalized epilepsy: A meta-analysis
• Imaging the Centromedian Thalamic Nucleus Using Quantitative Susceptibility Mapping.
• Ultrasound Blood-Brain Barrier Opening and Aducanumab in Alzheimer's Disease.
• RNS System NAUTILUS Study (NAUTILUS)
• Teratogenic potential of third-generation antiepileptic drugs: Current status and research needs.
• Network Substrates of Centromedian Nucleus Deep Brain Stimulation in Generalized Pharmacoresistant Epilepsy
• Centromedian Nucleus and Epilepsy
• Centromedian thalamic neuromodulation for the treatment of idiopathic generalized epilepsy

MeSH Terms

Conditions

Epilepsy, Idiopathic Generalized; Epilepsy, Generalized; Epilepsy; Seizures

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ahmed Raslan, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael McGehee, MS

CONTACT

971-509-4932; nsgclinicalresearch@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurological Surgery

Model Details: Exablate 4000 Type 1.0 and Type 1.1

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: September 4, 2026
• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): June 1, 2031
• Last Updated: September 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Data will be uploaded for each subject following each respective 90 days follow-up until study conclusion.
• Access Criteria: Principal Investigator and IRB-approved study team members will have access to this information and are able to share with others via password protected link.

Locations

US (1)