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.
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.
1. Pregnancy.
Unable or unwilling to comply with inclusion criteria as described.
Patients with advanced kidney disease or on dialysis
Patients who are not candidates for HIFU.
Single group
Intervention 1
DeviceHIFU ablation of dominant-hemisphere centromedian thalamic nucleus (CMN), or dominant seizure activity hemisphere
Intervention 2
DeviceHIFU ablation of contralateral centromedian thalamic nucleus (CMN)
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.
Primary Aim 2
Number of participants with decreased seizure frequency or severity as assessed according to the ILAE classification.
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Oregon Health and Science University
Lead sponsor
InSightec
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
