Last updated on January 2019

A Pilot Study: Focused Ultrasound Thalamotomy for the Prevention of Secondary Generalization in Focal Onset Epilepsy

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Partial Seizures With Secondary Generalization
  • Age: Between 18 - 65 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Disabling, medically refractory epilepsy (2 anti-epileptic drug failures)
  • Focal onset seizures with secondary generalization; with or without primary generalized seizures.
  • 3 seizures/month on average within 3 months of enrollment.
  • Stable medication dosage for 3 months before enrollment.
  • 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.
  • 18-65 years of age, inclusive.
  • Previous seizure work-up within 12 months of enrollment date to include:
  • Home EEG or EMU video EEG or intracranial EEG.
  • Baseline neuropsychological assessment, which includes the Wechsler Advanced Clinical Solutions - Test of Premorbid Functioning (TOPF). Subjects obtaining an IQ score of 70 on the TOPF will be included.
  • High definition MRI imaging/PET imaging.

Exclusion Criteria:

  • Low seizure frequency (<3 seizures/month).
  • Previous vagal nerve stimulator.
  • Severe untreated neuropsychiatric disorders (untreated depression or behavioral problems).
  • Recent history of drugs or alcohol abuse.
  • Generalized epilepsy (Lennox Gastaut, drop attacks).
  • Post infectious epilepsy (post herpetic).
  • Previous corpus callosotomy.
  • Significant structural brain abnormalities.
  • Unable or unwilling to maintain drug dosage for 3 months post treatment.
  • Pregnant or not practicing birth control method acceptable to the principal investigator.
  • History of claustrophobia.
  • Known allergic reaction and/or hypersensitivity to IV dye and/or IV contrasting agent(s).
  • Skull Density Ratio (SDR) <0.4.
  • IQ score of <70 on the Wechsler Advanced Clinical Solutions - Test of Premorbid Functioning (TOPF), a measure conducted as part of baseline neuropsychological assessment.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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