Oregon Health and Science University
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.
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 medic…
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 s…
HIFU ablation of dominant-hemisphere centromedian thalamic nucleus (CMN), or dominant seizure activity hemisphere
HIFU ablation of contralateral centromedian thalamic nucleus (CMN)
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