A Study to Evaluate MR-guided Focused Ultrasound Ablation Therapy to Treat Focal Epilepsy.

Overview

About this study

The purpose of this study is to evaluate the feasibility, safety, and initial effectiveness of ExAblate thermal ablation of a subcortical 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Seizure refractory to at least three standard antiepileptic medications at adequate doses, failed for lack of effectiveness. 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 partial-onset seizures with or without secondary generalization.
  • Subjects should have evidence suggesting the target lesion is 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 epilepsy secondary to a dysplastic subcortical lesion which would include: Hypothalamic hamartoma, Periventricular nodular hetereotopia, Dysembryoplastic neuroepithelial tumor (DNET), Cortical dysplasia, or Tuberous sclerosis.

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.
  • Subjects who are candidates for traditional open surgery or elect to receive traditional open surgery are excluded.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Jamie VanGompel, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Additional contact information

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