MR-Guided Focused Ultrasound in the Treatment of Focal Epilepsy
MR-Guided Focused Ultrasound in the Treatment of Focal Epilepsy
The purpose of this study is to evaluate the feasibility, safety, and initial effectiveness
 of Exablate thermal ablation of a focal epileptic target area in the brain of patients
 suffering from medication-refractory epilepsy, using the Exablate transcranial system to
 produce multiple sonications targeted in the focus of interest. The investigators will
 establish the feasibility and collect data to establish the basic safety of this type of
 treatment as the basis for later studies that will evaluate its full clinical efficacy.
The purpose of this study is to evaluate the feasibility, safety, and initial effectiveness
 of Exablate thermal ablation of a focal epileptic target area in the brain of patients
 suffering from medication-refractory epilepsy, using the Exablate transcranial system to
 produce multiple sonications targeted in the lesion of interest. The Investigators will
 establish the feasibility and collect data to establish the basic safety of this type of
 treatment as the basis for later studies that will evaluate its full clinical efficacy.

 The hypotheses tested are that:

 1. MRgFUS treatment of focal epilepsy is feasible and safe, with a low risk of adverse
 effects as evaluated during the follow-up period.

 2. Exablate treatment of foci in patients with focal epilepsy reduces the seizure
 frequency.
Inclusion Criteria:

 -  Seizure refractory to at least three standard antiepileptic medications at adequate
 doses, failed for lack of efficacy. This may include a rescue medication designated
 use as PRN.

 -  A minimum of 3 seizures per month for 2 months by patient diary started at intake
 interview.

 -  Subjects should have focal seizures with or without secondary generalization.

 -  Subjects should have evidence suggesting the focus within the periventricular white
 matter, basal ganglia, thalamus, hypothalamus, or mesial temporal lob has been
 previously determined as the source of seizures by standard clinical criteria
 including at least the description of seizures, physical examination, neuroimaging,
 and video EEG monitoring capturing at least one seizure.

 -  Subjects must be taking 2 medications during the Baseline period and the dosage must
 be stable.

 -  A diagnosis of intractable lesional epilepsy which may include: Hypothalamic
 hamartoma, Periventricular nodular hetereotopia, Dysembryoplastic neuroepithelial
 tumor (DNET), Cortical dysplasia, Tuberous sclerosis, Focal cortical gliosis, or
 Predominately unilateral Mesial Temporal Lobe Epilepsy (MTLE)

 Exclusion Criteria:

 -  Patients with standard contraindications for MR imaging such as non-MRI compatible
 implanted metallic devices including cardiac pacemakers, size limitations, etc.

 -  Individuals who are not able or willing to tolerate the required prolonged stationary
 supine position during treatment (can be up to 4 hrs of total table time.).

 -  Patients with malignant brain tumors.

 -  Patients with a known history of psychogenic non-epileptic spells in the last three
 years.

 -  Patients with a vagal nerve stimulator, deep brain stimulator, other implanted
 electronic device, or prior radiofrequency lesion techniques.

 -  Lesions in the brainstem or cerebellum.

 -  Subjects with symptomatic generalized epilepsy.

 -  Subjects with only simple partial seizures.

 -  Subjects who have had convulsive status epilepticus within 12 months prior to
 baseline.

 -  Subjects with a prior diagnosis of psychogenic/non-epileptic seizures within the last
 5 years.