.An Open-label Clinical Trial Evaluating the ExAblate Model 4000 Type-1 Focused Ultrasound Unilateral Thalamotomy for Patients with Treatment-refractory Focal Onset Epilepsy and Comorbid Anxiety.
The purpose of this study is to evaluate the feasibility, safety, and effects on anxiety of high intensity focused ultrasound ablation (FUSA) in patients suffering from treatment-refractory focal epilepsy and anxiety. FUSA is a non-invasive neurosurgical procedure that uses ultrasound waves, sent directly through the scalp and skull, to precisely target small abnormal areas of the brain. For this study, the targeted area of the brain is the anterior nucleus of the thalamus. This brain region may cause seizures and may also be involved in anxiety. The study will test if FUSA is safe and tolerated, and if it reduces anxiety and brain response to threat in patients with anxiety receiving the procedure for partial-onset epilepsy that is resistant to medications.
• Disabling, medically refractory epilepsy (≥2 anti-epileptic drug failures).
• Focal onset seizures with secondary generalization; with or without primary generalized seizures.
• Previous seizure work-up within 12 months of enrollment date to include:
⁃ A. Home EEG or EMU video EEG or intracranial EEG. B. High definition MRI imaging/PET imaging. C. Baseline neuropsychological assessment, which includes the Wechsler Advanced Clinical Solutions - Test of Premorbid Functioning (TOPF).
• ≥ 3 seizures/month on average within 3 months of enrollment.
• Stable medication (including anti-epileptic and psychotropic/psychoactive medications) dosage for 3 months before enrollment.
• Moderate-severe anxiety as measured by the Hamilton Anxiety Rating Scale (HAM-A) score \> 17.
• Anterior Nucleus (AN) identifiable on MRI (structural T1 and T2 images).
• Willing to maintain seizure diary (3 months before \& 3 months after).
• Involved care provider.
• Written informed consent to participate.
• Ability to comply with all testing, follow-ups, and study appointments and protocols.