High-Intensity Focused Ultrasound for Epilepsy
(HIFU for MRGE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Ahmed Raslan, MD
Principal Investigator
Oregon Health and Science University
Are You a Good Fit for This Trial?
This trial is for adults aged 18 to 89 who have generalized epilepsy that hasn't improved with standard treatments. Participants should still be having seizures despite trying available medications.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- High-Intensity Focused Ultrasound (HIFU)
Trial Overview
The study tests MRI-guided high-intensity focused ultrasound (HIFU), a non-invasive procedure using targeted sound waves to treat brain tissue linked to seizures, aiming to see if it safely reduces seizure frequency in people with hard-to-treat epilepsy.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Oregon Health and Science University
Lead Sponsor
InSightec
Industry Sponsor
Dr. Maurice R. Ferré
InSightec
Chief Executive Officer
MD
Dr. Arjun Desai
InSightec
Chief Medical Officer
MD
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